Sop-Exl 200

R. K.
LIFE SERVICES PRIVATE LIMITED

(Department of Laboratory Medicine)
Doc No. RKLS/SOP/01 SOP BIOCHEMISTRY
STANDARD OPERATING
PROCEDURE
(BIOCHEMISTRY)
PREPARED AS PER ISO 15189:2012
COPY NO: MASTER COPY
HOLDER: QUALITY MANAGER
ISSUE NO: 04
ISSUE DATE: 09.03.2020
Issue No. 04 Issue Date: 09.03.2020 Prepared By: Copy No. Page 1 of 1
Rev. No.: 01 Rev. Date: 18.08.2022 Approved By: Issued By

R. K. LIFE SERVICES PRIVATE LIMITED
AMENDMENT SHEET
Sl. Page Section/ Date of Amendment Reasons Signature Signature

No. No. Clause Amendment Made of
No. of QM Laboratory
Director
01 All All 09.03.2020 Issue No: 03 Change in
has been automated
withdrawn analyser
and issue no
04 is issued in
the system
02 2-69 Reportable 18.08.2022 Reportable Adequacy
Interval Interval has Raised in
changed Assessment
Issue No. 04 Issue Date:09.03.2020 Prepared By: Copy No. Page 1 of 1
Rev. No.: 00 Rev. Date: Nil Approved By: Issued By

TABLE OF CONTENTS
LAST
CHAPTER SL. REVISION
TITLE REVISION PAGE No.
No. No. NO
MADE
GLUCOSE
1 00 00 02 – 05
UREA
2 00 00 06 – 08
CREATININE
3 00 00 09 - 11
TOTAL BILIRUBIN
4 00 00 12 - 14
DIRECT BILIRUBIN
5 00 00 15 - 17
TOTAL PROTEIN
6 00 00 18 - 20
ALBUMIN
7 00 00 21 - 23
ALKALINE
8 PHOSPHATASE 00 00 24 - 27
ALT (SGPT)
I 9 00 00 28 - 31
AST (SGOT)
10 00 00 32 - 34
CHOLESTEROL
11 00 00 35 - 38
TRIGLYCERIDE
12 00 00 39 - 42
HDL CHOLESTEROL
13 00 00 43 - 46
URIC ACID
14 00 00 47 - 50
PHOSPHOROUS
15 00 00 51 - 54
CALCIUM
16 00 00 55 - 58
GAMMA-GT
17 00 00 59 - 62
Rev. No.: 00 Rev. Date: Nil Approved By: Issued By:

LAST
CHAPTER SL. REVISION
TITLE REVISION PAGE No.
No. No. NO
MADE
18 LDL CHOLESTEROL 00 00 63 - 66
SODIUM, POTASSIUM & CHLORIDE
19 00 00 67 – 69
MACHINE OPERATION
II 00 00 1–2
PROCEDURE
III QUALITY CONTROL PROCEDURE 00 00 1–4
IV CALIBRATION PROCEDURE 00 00 1–1
SAFETY PRECAUTION
V 00 00 1–1
VI LIST OF CRITICAL ALERT VALUE 00 00 1–1
Rev. No.: 00 Rev. Date: Nil Approved By: Issued By:

Doc No. RKLS/SOP/01 SOP BIOCHEMISTRY CHAPTER - I
NAME OF TEST: GLUCOSE

a) Purpose of examination
The GLUC method for the Dimension® clinical chemistry system is an in vitro
diagnostic test intended for the quantitative determination of glucose in
human serum, plasma, urine, and cerebrospinal fluid.
b) Principle of the Procedure used for Examination

Hexokinase (HK) catalyzes the phosphorylation of glucose in the presence of
adenosine-5’-triphosphate (ATP) and magnesium to form glucose-6-phosphate
(G-6-P) and adenosinediphosphate (ADP). G-6-P is then oxidized by glucose-
6-phosphate dehydrogenase (G-6-PDH) in the presence of nicotinamide
adenine dinucleotide (NAD) to produce 6-phosphogluconate and NADH. One
mole of NAD is reduced to one mole of NADH for each mole of glucose
present. The absorbance due to NADH (and thus the glucose concentration) is
determined using a bichromatic (340 and 383 nm) endpoint technique.
Method: Hexokinase.
c) Performance characteristics
The test linearity is 0 – 500 mg/dL.
Analytical Sensitivity: 1 mg/dL.
The analytical sensitivity represents the lowest concentration of GLUC that
can be distinguished from zero.
d) Primary Sample System

Plasma.
e) Patient preparation:
QMSP 15

f) Type of container & additives

Fluoride Vial.
g) Required equipment and reagents

1. DIMENSION EXL 200 2. Centrifuge, 3. Test Tube Racks, 4. Sample
container and 5.Glucose kit.
h) Environmental and safety controls

1. Temp: 200C-280C
2. Humidity: not more than 80% -90%
3. Dust free.
Sample storage:
The sample is stored at 2 – 8ºC for 1 day.
i) Calibration procedure
Periodic hardware calibration is done by the manufacturer. Parameter
specific calibration with standards is done in the following cases:
1. L-J Chart shows rejection Multi QC rule.
2. Lot change of reagent.
3. EQAS result shows outliers.
All auxiliary equipments are calibrated as per NABL 112.
j) Procedural steps
Assay procedure is performed automatically by the instrument.
Operation of instrument
Sample is collected, processed as per requirement and then the examination
is carried out following the operating procedure as described in chapter –II.
k) Quality Control Procedure

For internal quality assessment commercial control is run daily.2 different
levels i.e level1 and level 2 are run every day. The laboratory participates in
Biorad monthly EQAS programme. Detailed Quality Control Procedure is
mentioned in Chapter-III
l) Interferences
Hemoglobin (hemolysate) at 1000 mg/dL [0.62 mmol/L] decreases a GLUC result at
50 mg/dL [2.8 mmol/L] by 11%.
Bilirubin (unconjugated) at 60 mg/dL [1026 μmol/L] increases a GLUC result at 50
mg/dL [2.8 mmol/L] by 13%.

Lipemia (Intralipid®) at 200 mg/dL [2.29 mmol/L] increases a GLUC result at 50

Pralidoxime iodide (PAM) concentration of 512 μg/mL [1.93 mmol/L] increases a
GLUC result of
78 mg/dL [4.3 mmol/L] by 17%.
Pralidoxime iodide (PAM) concentration of 1024 μg/mL [3.88 mmol/L] increases a
GLUC result of
204 mg/dL [11.5 mmol/L] by 13%.
m) Principle of Procedure for calculating result including, relevant, the

measurement uncertainty of measured quality values
Instrument automatically calculates the result. CV% is calculated from
internal QC data. MU% is calculated using the formula CV% X 1.96.
n) Biological Reference intervals or clinical decision values:

70-100 mg/dl. (F)
<140 mg/dl (PP)
<200 mg/dl (Random)
o) Reportable interval of examination results

0-500 mg/dl
p) TAT
Regular: 8 hrs
Emergency: 2 hrs
q) Instruction for determining quantitative results when a result is not

within the measurement interval
Sample having glucose value more than 500 mg/dL should be auto diluted
and re-run.

r) Alert/Critical values, where applicable

Adult: <40 mg/dl, >450 mg/dl
Newborn : <30 mg/dl, > 300mg/dl
s) Laboratory clinical interpretation:

The instrument automatically calculates and prints the concentration of
glucose in mg/dL.
Results of this test should always be interpreted in conjunction with the
patient’s medical history, clinical presentation and other findings.
t) Potential source of variability

Demographic variations and diseased conditions.
Diagnosis of diabetes mellitus (defined by WHO) – Increase of 2 hrs. post load
plasma glucose concentration > 200mg/dl and Fasting plasma glucose > 126
mg/dl is indicative of diabetes mellitus.
Increased values are observed in diabetes mellitus, hemochromatosis,
acromegaly, gigantism, Cushing’s syndrome, increased epinephrine level,
pancreatities, Wernicke’s encephalopathy, CNS lesions. Decreased values are
observed in pancreatic disorder, carcinoma of adrenal gland, carcinoma of
stomach, certain hepatic disease and endrocrine disorders as hypo-
pituitarism, hypothyroidism and malnutrition.
u) Document Reference:
1. Principle and procedure:
a. Kit Instruction.
b. John Bernard Henry, M.D.
2. Biological reference Interval :
a. ADA Guideline
b. Ref: Jacques Wallach, Md
Interpretation of diagnostic test 8th edition page
26-27. Lippincort.

NAME OF TEST: UREA/BUN
The BUN method used on the Dimension® clinical chemistry system is an in
vitro diagnostic test intended for the quantitative determination of urea
nitrogen in human serum, plasma and urine.

Urease specifically hydrolyzes urea to form ammonia and carbon dioxide.
The ammonia is used by the enzyme glutamate dehydrogenase (GLDH) to
reductively aminate α-ketoglutarate (α-KG), with simultaneous oxidation of
reduced nicotinamide-adenine dinucleotide (NADH). The change in
absorbance at 340 nm due to the disappearance of NADH is directly
proportional to the BUN concentration in the sample and is measured using
a bichromatic (340, 383 nm) rate technique.
Urease
Urea +H2O 2NH3 + CO2
GLDH
NH3 + α-KG + L-glutamate +
NADH NAD
Method: UREASE/ GLDH

The test has a linearity range of 0 – 150 mg/dL.
Analytical Sensitivity: 1 mg/dL

The analytical sensitivity represents the lowest concentration of BUN that can
be distinguished from zero.

Serum.
QMSP 15

Plain Vial / Gel Vial/ Clot vial.


1. DIMENSION EXL 200 2. Centrifuge, 3. Sample cups, 4.Urea reagent
cartridge.

1. Temp: 200C-280C
3. Dust free.
Sample storage:
The conversion factor of 2.14 must be applied to the BUN calibrator bottle
values (mg/dL) prior to calibrating, to express the results of urea nitrogen as
urea.
j) Procedural steps

levels i.e level 1 and level 2 are run daily. The laboratory participates in Bio
Rad monthly EQAS programme.
l) Interferences
This method reacts quantitatively with ammonium ions.
Triglyceride (Intralipid®) of 1000 mg/dL [11.3 mmol/L] and above tripped a
test report message; therefore the magnitude of the interference could not be
determined.


n) Biological Reference intervals
In serum / plasma:
Adult: 17 – 43 mg/dl
Newborn: 8.4 – 25.8 mg/dl
Infant/Child: 10.8 – 38.4 mg/dl
o) Reportable interval of examination results:
6-250 mg/dl
p) TAT
Regular: 8 hrs
Emergency: 2 hrs
Sample having UREA value more than 150 mg/dl should be auto diluted and
re-run.
>171 <4.20
s) Laboratory clinical interpretation:

Results of this test should always be interpreted in conjunction with the
patient’s medical history, clinical presentation and other findings.

Elevated values are observed in impaired kidney functions, liver diseases,
congestive cardiac failure, diabetes and in infections of Kidneys.
a. Kit Instruction.
a. Kit Literature.
26-27. Lippincort.

NAME OF TEST: CREATININE
The CREA method used on the Dimension® clinical chemistry system is an in
vitro diagnostic test intended for the quantitative determination of creatinine
in human serum, plasma and urine.

In the presence of a strong base such as NaOH, picrate reacts with creatinine
to form a red chromophore. The rate of increasing absorbance at 510 nm due
to the formation of this chromophore is directly proportional to the creatinine
concentration in the sample and is measured using a bichromatic
(510, 600 nm) rate technique. Bilirubin is oxidized by potassium ferricyanide 3
to prevent interference.
NaOH
Creatinine + Red
Picrate chromophore
(absorbs at
510 nm)
Method: Kinetic Jaffe
The method has a linearity range of 0 – 20.0 mg/dL.
Analytical Sensitivity: 0.05 mg/dL.

The analytical sensitivity represents the lowest concentration of creatinine
that can be distinguished from zero.
d) Type of Sample: Serum.
e) Patient preparation: QMSP 15


1. DIMENSION EXL 200 2. Centrifuge 3. Sample cups 4. Creatinine reagent
cartridge.


1. Temp: 200C-280C
3. Dust free.
Sample storage:
Periodic hardware calibration is done by the manufacturer. Parameter specific
calibration with standards is done in the following cases:
j) Procedural steps

l) Interferences
Interfering Substances
Bilirubin (unconjugated) at 20 mg/dL [342 µmol/L] and 40 mg/dL [684
µmol/L] decreases a CREA result of 1.7 mg/dL [150.3 µmol/L] by 12% at
standard sample volume.
Bilirubin (unconjugated) at 60 mg/dL [1026 µmol/L] decreases a CREA result
of 1.7 mg/dL [150.3 µmol/L] by 57% at standard sample volume.
Lipemia (Intralipid®) interference testing at levels 600 mg/dL [6.78 mmol/L]
and greater tripped a test report message; therefore the magnitude of the
interference could not be determined.


Serum/ plasma not compensated:
Male < 50 years: 0.84 – 1.25 mg/dl
Male > 50 years: 0.81 – 1.44 mg/dl
Female: 0.66 – 1.09 mg/dl
Neonate: 0.5 – 1.2 mg/dl
Infant: 0.4 – 0.7 mg/dl
Child: 0.5 – 1.2 mg/dl
o) Reportable interval of examination results
Regular: 8 hrs
Emergency: 2 hrs
p) Instruction for determining quantitative results when a result is not
Sample having creatinine value more than 20 mg/dl should be auto diluted
and re-run.
q) Alert/Critical values, where applicable
> 5 mg/dL.
r) Laboratory clinical interpretation: Not done
s) Potential source of variability

Creatinine is an useful indicator of renal function. Elevated level is
associated with various renal diseases. Increased level is also observed in
muscular dystrophy, congestive heart failure, shock and obstruction of
urinary tract.
t) Document Reference:
a. Kit Instruction.
a. Kit Literature.
26-27. Lippincort.

NAME OF TEST: TOTAL BILIRUBIN
The TBI method for the Dimension® clinical chemistry system is an in vitro
diagnostic test intended to quantitatively measure total bilirubin in human
serum and plasma. Measurements of total bilirubin are used in the diagnosis
and treatment of liver, hemolytic, hematological, and metabolic disorders,
including hepatitis and gallbladder disease.

Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic
acid at low pH. Bilirubin (unconjugated) in the sample is solubilized by
dilution in a mixture of caffeine/benzoate/acetate/EDTA. Upon addition of
the diazotized sulfanilic acid, the solubilized bilirubin including conjugated
bilirubins (mono and diglucoronides) and the delta form 4 (biliprotein-bilirubin
covalently bound to albumin) is converted to diazo-bilirubin, a red
chromophore representing the total bilirubin which absorbs at 540 nm and is
measured using a bichromatic (540, 700 nm) endpoint technique. A sample
blank correction is used.
Solubilized bilirubin + Red chromophore

Diazotized sulfanilic acid (absorbs at 540
nm)
Method: DPD
The Linearity is 0.1 – 25.0 mg/dL

The analytical sensitivity represents the lower limit of detection (lowest
concentration of total bilirubin that can be distinguished from zero).

Serum.
QMSP 15



1. DIMENSION EXL 200 2. Centrifuge, 3. Sample cups, 4. Micro pipettes
of variable volume, 5. Micro tips and 6.Tolat bilirubin reagent.

1. Temp: 200C-280C
3. Dust free.
Sample storage:
Periodic hardware calibration is done by the manufacturer. Parameter specific
calibration with standards is done in the following cases:
j) Procedural steps

For internal quality assessment commercial control is run daily.2
different levels i.e level 1 and level 2 are run daily. The laboratory
participates in Bio Rad monthly EQAS programme.
l) Interferences
The TBI method was evaluated for interference according to CLSI/NCCLS EP7-A.10 Bias is
the difference in the results between the control sample (without the interferent) and the test
sample (contains the interferent) expressed in mg/dL [µmol/L]. Bias exceeding 10% is
considered interference.
Concentration
Interferent SI Units Total Bilirubin Bias Bias (%)
Levodopa 300 µg/mL 1.1 mg/dL +2.6 mg/dL +236
[1.52 mmol/L] [19 µmol/L] [44 µmol/L]

Lipemia 600 mg/dL 1.1 mg/dL +0.2 mg/dL +18

(Intralipid®) [6.78 mmol/L] [19 µmol/L] [3 µmol/L]
Phenazopyridine 80 µg/mL 1.1 mg/dL +0.8 mg/dL +42
[320 µmol/L] [19 µmol/L] [14 µmol/L]
Adults : 0.3-1.2 mg/dl
Children
0-1 day 1.4-8.7 mg/dl
1-2 day 3.4-11.5 mg/dl
3-5 day 1.5-12.0 mg/dl
o) Reportable Interval
0-25 mg/dl
p) Instruction for determining quantitative results when a result is not
Sample having Total Bilirubin value more than 25 mg/dL should be auto
diluted and re-run.
q) Alert/Critical values, where applicable
Newborn : > 15 mg/dl
r) Laboratory clinical interpretation: Not done
s) Potential source of variability

Elevated bilirubin may be indicative of obstructive condition of bile duct,
hepatitis, cirrhosis, hemolytic disorder, toxic condition, infection, neoplasm
and genetic diseases.
t) Document Reference:
a. Kit Instruction.
a. Kit Literature.


NAME OF TEST: DIRECT BILIRUBIN
The DBIL method used on the Dimension® clinical chemistry system is an in
vitro diagnostic test intended for the quantitative determination of direct
(conjugated) bilirubin in human serum and plasma.

Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic
acid at low pH. The sample is diluted in 0.05M HCl. A blank reading is taken
to eliminate interference from non-bilirubin pigments. Upon addition of the
diazotized sulfanilic acid, the conjugated bilirubin is converted to diazo-
bilirubin, a red chromophore which absorbs at 540 nm and is measured
using a bichromatic (540, 700 nm) endpoint technique.
Conjugated bilirubin + Diazotized Red chromophore

sulfanilic acid
(absorbs at 540 nm)
Method: DPD
The Linearity is 0.00 – 20.00 mg/dL.

The analytical sensitivity represents the lowest concentration of direct
bilirubin that can be distinguished from zero.

Serum.
QMSP 15



1. DIMENSION EXL 200 2. Centrifuge, 3. Sample cups, 4. Micro pipettes of
variable volume, 5. Micro tips, 6.Direct bilirubin reagent.

1. Temp: 200C-280C
3. Dust free.
Sample storage:
j) Procedural steps

l) Interferences
Lipemia (Intralipid®) of 600 mg/dL [6.78 mmol/L] and greater at a DBIL
value of 0.17 mg/dL [2.19 µmol/L] tripped a test report message; therefore
the magnitude of the interference could not be determined.
Hemolysis may depress DBIL results. Follow your laboratory’s procedures for
reporting results when the sample is hemolyzed.



Adults and children : < 0.2 mg/dl

0-20 mg/dl
p) TAT
Regular: 8 hrs
Emergency: 2 hrs

Sample having Direct Bilirubin value more than 20 mg/dl should be auto
diluted and re-run.

Newborn : > 15 mg/dl
s) Laboratory clinical interpretation: Not done

Elevated level is indicative of infections, hepatic disorders, haemolytic
disorders, biliary duct obstruction, toxic state, metastatic tumour and
hereditary disorders.
c. Kit Instruction.
d. John Bernard Henry, M.D.
c. Kit Literature.
d. Ref: Jacques Wallach, Md
26-27. Lippincort.

NAME OF TEST: TOTAL PROTEIN
The TP method used on the Dimension ® clinical chemistry system is an in
vitro diagnostic test intended for the quantitative determination of total
protein in human serum and heparinized plasma. Measurements of total
protein are used in the diagnosis and treatment of a variety of diseases
involving the liver, kidney or bone marrow as well as metabolic or nutritional
disorders.
Cupric ion (Cu++) reacts with the peptide linkages of protein in a basic solution.
The blue copper (II) protein complex thus formed is proportional to the total protein concentration in
the sample and is measured using a bichromatic (540, 700 nm) endpoint technique.
Method: Biuret Reaction
The Linearity is 2.0 – 12.0 g/dL.
Analytical Sensitivity: ≤ 2.0 g/dL.

The analytical sensitivity represents the lowest concentration of TP that can
be distinguished from zero.

Serum.
QMSP 15



variable volume, 5. Micro tips and 6.Tolat Protein reagent.

1. Temp: 200C-280C
3. Dust free.
Sample storage:
j) Procedural steps

l) Interferences
Dextran 40 of 1500 mg/dL [375 μmol/L] increases a TP result of 7.0 g/dL [70 g/L]
by 17%.
Immunoglobulin G of 2.5 g/dL [25 g/L] increases a TP result of 7.0 g/dL [70 g/L] by
25%.
Using standard sample size (15 μL):
Hemoglobin (hemolysate) of 500 mg/dL [0.31 mmol/L] (monomer) increases a TP
result of 3.9 g/dL [39 g/L] by 11%.
Bilirubin (unconjugated) of 20 mg/dL [342 μmol/L] decreases a TP result of 3.8 g/dL
[38 g/L] by -11%.

Lipemia (Intralipid®) of 600 mg/dL [6.78 mmol/L] and above tripped an error flag on
this method, so the magnitude of the interference is not available.
Adults : 6.6-8.3 g/dL
Children (1-18 y) : 5.7-8.0 g/dl
New- born (1-30 d) : 4.1-6.3 g/dl
2-12 gm/dl
p) TAT
Regular: 8 hrs
Emergency: 2 hrs
Sample having Total Protein value more than 12.0 g/dl should be auto
diluted and re-run.
Not Applicable.
Increased levels are observed in dehydration, multiple myeloma, chronic liver
diseases, chronic infections. Decreased values are observed in renal diseases,
malnutrition, albuminuria and terminal liver failure.
a. Kit Instruction.
a. Kit Literature.
26-27. Lippincort.

NAME OF TEST: ALBUMIN
The ALB method used on the Dimension® clinical chemistry system is an
in vitro diagnostic test intended for the quantitative determination of
albumin in human serum and plasma.

In the presence of a solubilizing agent, BCP binds to albumin at pH 4.9.
The amount of albumin-BCP complex is directly proportional to the
albumin concentration. The complex absorbs at 600 nm and is measured
using a polychromatic (600, 540, 700 nm) endpoint technique.
pH 4.9
Albumin + BCP Albumin-BCP
dye complex
(nonabsorbing at (absorbs at 600 nm)
600 nm)
Method: BROMOCRESOL GREEN
c) Analytical measuring range.

Then linearity range of the test is from 0.6 – 8.0 g/dL.
Analytical Sensitivity: 0.6 g/dL

The analytical sensitivity represents the lowest concentration of albumin
that can be distinguished from zero.

Serum.
QMSP 15



variable volume, 5. Micro tips and 6.Albumin reagent.

1. Temp: 200C-280C
3. Dust free.
Sample storage:
j) Procedural steps

l) Interferences
CMPF (3-carboxy-4-methyl-5-propyl-2-furanpropanoic acid) present in sera of
patients with renal failure has been reported to give falsely low albumin values.
Lipemia (Intralipid®) at 1000 mg/dL [11.3 mmol/L] and above tripped a test report
message; therefore the magnitude of the interference could not be determined.



Adults: 3.5 – 5.2 g/dl.
Newborn: 2.8 – 4.4 g/dl

0.6-8 g/dl
p) TAT
Regular: 8 hrs
Emergency: 2 hrs

Sample having Albumin value more than 8 g/dL should be manually diluted
and re-run.

Not Applicable.
s) Laboratory clinical interpretation: Not Done

Increased levels are observed in dehydration, stasis during venipuncture.
Decreased levels are observed in over hydration, excessive protein loss
from kidney, skin or intestine, liver diseases, malnutrition, mal-
absorption, decreased synthesis, hypertension and increased catabolism
as in diabetes mellitus.
a. Kit Instruction.
a. Kit Literature.
26-27. Lippincort.

NAME OF TEST: ALKALINE PHOSPHATASE
The ALP method used on the Dimension® clinical chemistry system is an in
protein in human serum and plasma.

Alkaline phosphate catalyzes the transphosphorylation of p-
nitrophenylphosphate (p-NPP) to p-nitrophenol (p-NP) in the presence of the
transphosphorylating buffer, 2 amino-2-methyl-1 propanol (AMP) The
reaction is enhanced through the use of Magnesium (Mg is essential for
stability and for catalytic activity) and Zinc ions .The reaction is change in
absorbance at 405 nm due to the formation of p-NP is directly proportional to
the ALP activity, since other reactants are in non-rate limiting quantities and
is measured using bichromatic (405, 510 n m) rate technique.
ALP
p-NPP + AMP p-NP + AMP +PO4
pH 10.35 Mg/Zn
Method : IFCC KINETIC AMP BUFFER
c) Performance characteristics .
The linearity range of the test is from 10-1000 U/L
Analytical Sensitivity: 10 U/L

The analytical sensitivity represents the lowest concentration of albumin that
Serum.
QMSP 15

Plain Vial / Gel Vial / Clot Vial


1. DIMENSION EXL 200 2. Centrifuge, 3. Sample cups, 4. Alkaline
phosphatase reagent.

1. Temp: 200C-280C
3. Dust free.
Sample storage:
j) Procedural steps

l) Interferences
Results of studies conducted to evaluate the susceptibility of the method
to interference were as follows:
Icterus Interference less than 10% up to 28 mg/dl or 479 µmol/L
bilirubin
Haemolysis Interference less than 10% up to 4.5 g/L haemoglobin
lipemia Interference less than 3% up to 1000 mg/dl Intralipid



Adults >17y: 30 – 120 U/L
Children Male (U/L) Female(U/L)
1- 30d 75-316 48-406
30d-1y 82-383 124-341
1-3y 104-345 108-317
4-6y 93-309 96-297
7-9y 86-315 69-325
10-12y 42-362 51-332
13-15y 74-390 50-162
16-18y 52-171 47-119

0-1000 U/L
p) TAT
Regular: 8 hrs
Emergency: 2 hrs

Sample having ALP value more than 1000 U/L should be auto diluted and re-
run.

Not Applicable.
Elevated values are obtained in pregnant women and growing children.
Increased levels occur in Hodgkins disease or congestive heart failure bile
duct obstruction, cirrhosis of liver, hyper parathyroidism, infectious
mononucleosis, osteogenic sarcoma, rickets, osteomalacia, metastatic
tumour in bone. Decreased levels occur in hypophosphatasia and
malnourished patients.

a. Kit Instruction.
a. Kit Literature.
26-27. Lippincort.

NAME OF TEST: ALT (SGPT)
The alanine aminotransferase (ALTI) method is an in vitro diagnostic test for
the quantitative measurement of alanine aminotransferase activity in human
serum or plasma on the Dimension® clinical chemistry system.
Measurements of alanine aminotransferase are used in the diagnosis and
treatment of certain liver diseases and heart diseases.

Alanine aminotransferase catalyzes the transamination of L-alanine to α-
ketoglutarate (α-KG), forming
L-glutamate and pyruvate. The pyruvate formed is reduced to lactate by
lactate dehydrogenase (LDH) with simultaneous oxidation of reduced
nicotinamide-adenine dinucleotide (NADH). The change in absorbance is
directly proportional to the alanine aminotransferase activity and is measured
using a bichromatic
(340, 700 nm) rate technique.
Method: IFCC ( without p -5 – p)
The linearity range of the test is 6 – 1000 U/L.

Serum.

QMSP 15


1. DIMENSION EXL 200 200 2. Centrifuge 3. Sample cups 4. Micro
pipettes of variable volume 5. Micro tips 6. ALT (SGPT) cartridge.

1. Temp: 200C-280C
3. Dust free.
Sample storage:
j) Procedural steps

l) Interferences
Bilirubin (unconjugated) at 60 mg/dL [1026 μmol/L] decreases ALTI results
at an activity of 68 U/L[1.14 μkat/L] by -11%.

Bilirubin (conjugated) at 40 mg/dL [684 μmol/L] decreases ALTI results at an

activity of 71 U/L [1.19 μkat/L] by -13%.
Bilirubin (conjugated) at 60 mg/dL [1026 μmol/L] decreases ALTI results at
an activity of 144 U/L [2.40 μkat/L] by -12%.
Triglycerides above 400 mg/dL[4.52 mmol/L] tripped a test report message
therefore the magnitude of the interference could not be determined.
Lipemia (Intralipid®) above 600 mg/dL[6.78 mmol/L] tripped a test report
message; therefore the magnitude of the interference could not be
determined.


Women < 35 U/L
Men < 50 U/L
Infant/ New born 13 – 45 U/L

0-1000 U/L
p) TAT
Regular: 8 hrs
Emergency: 2 hrs

Sample having ALT value more than 1000 U/L should be manually diluted
and re-run.

Not Applicable
s) Laboratory clinical interpretation: Not Done

Elevation of values observed in liver diseases such as cirrhosis, carcinoma,

viral hepatitis, obstructive jaundice. Diseases of kidney, heart, skeletal

muscle, pancreas, spleen and lungs also elevate ALT levels to some extent.

In renal dialysis patient and in Vitamin B6 deficiency lower level of ALT is

observed.
a. Kit Instruction.
a. Kit Literature.
26-27. Lippincort.

NAME OF TEST: AST (SGOT)
The ASTI method is an in vitro diagnostic test for the quantitative
measurement of AST activity in human serum or plasma on the Dimension ®
clinical chemistry system.

Aspartate aminotransferase (AST) catalyzes the transamination from L-
aspartate to α-ketoglutarate forming L glutamate and oxaloacetate. The
oxaloacetate formed is reduced to malate by amalate dehydrogenous (MDH)
with simultaneous oxidation of reduced nicotinamide adenine dinucleotide
(NADH). The change in absorbance with time due to the conversion of NADH
to NAD is directly proportional to the AST activity and is measured using
bichromatic (340, 700 nm) rate technique.
AST
L-aspartate + α-ketoglutarate Oxaloacetate + L-glutamate
pH 7.8
MDH
Oxaloacetate + NADH Malate +NAD
Method: IFCC ( without p -5 – p)
Test has a linearity range of 6 – 1000 U/L.
Serum.
QMSP 15



1. DIMENSION EXL 200 2. Centrifuge, 3. Sample cups, 4.AST reagent
cartridge.

1. Temp: 200C-280C
3. Dust free.
Sample storage:
j) Procedural steps

l) Interferences
Results of studies conducted to evaluate the susceptibility of the method to
interference were as follows:
Icterus: Interference less than 10% up to 40 mg/dL or 684 μmol/L bilirubin
Lipemia: Interference less than 5% up to 300 mg/dL Intralipid®
Pyruvate: Interference less than 10% up to 1 mmol/L pyruvate


Men : <50 U/L
Female : <35 U/L
Newborn : 25-75 U/L
Infant : 15-60 U/L
,
0-1000 U/L
p) TAT
Regular: 8 hrs
Emergency: 2 hrs
Sample having AST value more than 1000 U/L should be auto diluted and re-
run.
Not Applicable

Increased levels are observed in liver damage or diseases, myocardial
infarction, muscular dystrophy, cholecystitis, acute pancreatitis, cardiac
arrythmias, congestive heart failure, peri carditis, pulmonary infarction
and cirrhosis. Decreased levels are also seen in dialysis patients and
Vitamin B6 deficient patients.
a. Kit Instruction.
a. Kit Literature.


26-27. Lippincort.

NAME OF TEST: CHOLESTEROL
The CHOL method used on the Dimension® clinical chemistry system is an in
cholesterol in human serum and plasma.

Cholesterol esterase (CE) catalyzes the hydrolysis of cholesterol esters to
produce free cholesterol which, along with preexisting free cholesterol, is
oxidized in a reaction catalyzed by cholesterol oxidase (CO) to form cholest-4-
ene-3-one and hydrogen peroxide. In the presence of horseradish peroxidase
(HPO), the hydrogen peroxide thus formed is used to oxidize N,N
diethylaniline-HCl/4-aminoantipyrine (DEA-HCl/AAP) to produce a
chromophore that absorbs at 540 nm. The absorbance due to oxidized DEA-
HCl/AAP is directly proportional to the total cholesterol concentration and is
measured using a polychromatic (452, 540, 700 nm) endpoint technique.
CE
Cholesterol esters Cholesterol + Fatty Acids
CO
Cholesterol + O2 Cholest-4-ene-3-one + H2O2
HPO
2 H2O2 +
4 H2O + Oxidized DEA•HCl/AAP
DEA•HCl/AAP
Method: CHOD-POD
The linearity range of the test is 50 – 600 mg/dL.
Analytical Sensitivity: 50 mg/dL

The analytical sensitivity represents the lowest concentration of CHOL that

Serum.

QMSP 15


1. DIMENSION EXL 200 2. Centrifuge 3. Sample cups 4. Micro pipettes of
variable volume 5. Micro tips 6.Cholesterol reagent.

1. Temp: 200C-280C
3. Dust free.
Sample storage:

j) Procedural steps

For internal quality assessment commercial control is run daily. 2 different
l) Interferences
Potassium Oxalate/Sodium Fluoride can decrease cholesterol results an average of
12%.
Li Heparin can depress cholesterol results by an average of 4 mg/dL [0.1 mmol/L] at
a level of 200 mg/dL [5.2 mmol/L].
Bilirubin (conjugated) of 8.1 mg/dL [139 µmol/L] and bilirubin (unconjugated) of 9.4
mg/dL [161 µmol/L] decrease the CHOL result by 15 mg/dL [0.4 mmol/L] at CHOL
concentration of 150 mg/dL [3.9 mmol/L].
Bilirubin (conjugated) of 12.8 mg/dL [219 µmol/L] and bilirubin (unconjugated) of
14.7 mg/dL [251 µmol/L] decrease the CHOL result by 25 mg/dL [0.7 mmol/L] at
CHOL concentration of 250 mg/dL [6.5 mmol/L].
Bilirubin (unconjugated) of 20 mg/dL [342 µmol/L] decreases a CHOL result of 178
Hemoglobin (hemolysate) of 1000 mg/dL [0.62 mmol/L] (monomer) decreases a
CHOL result of 177 mg/dL [4.6 mmol/L] by 15%.
Lipemia (Intralipid®) at 1000 mg/dL [11.3 mmol/L] tripped a test report message;
therefore the magnitude of the interference could not be determined.


<200 mg/dl Desirable
200 - 239 mg/dl Borderline High
≥ 240 mg/dl High


50-600 mg/dl
p) TAT
Regular: 8 hrs
Emergency: 2 hrs

Sample having CHOL value more than 600 mg/dl should be manually diluted
and re-run.

Not Applicable

Hypercholesterolomia is observed in nephrosis, nephritis, diabetes
mellitus, obstructive jaundice, myxoedema, hypopituitarism, several liver
disease, coronary thrombosis, angina pectoris, obesity, familial
hyperlipoproteinemias.
Decreased values are observed in hyperthyroidism, anemias,
malabsorption syndrome and acute infections.
a. Kit Instruction.
c. Kit Literature.
d. Ref: Jacques Wallach, Md
26-27. Lippincort.

NAME OF TEST: TRIGLYCERIDES
The TGL method used on the Dimension ® clinical chemistry system is an in
vitro diagnostic test intended for the quantitative determination of
triglycerides in human serum and plasma. Measurements obtained are used
in the diagnosis and treatment of patients with diabetes mellitus, nephrosis,
liver obstruction, other diseases involving lipid metabolism, or various
endocrine disorders.

The triglycerides method is based on an enzymatic procedure in which a
combination of enzymes are employed for the measurement of serum or
plasma triglycerides. The sample is incubated with lipoprotein lipase (LPL)
enzyme reagent that converts triglycerides into free glycerol and fatty acids.
Glycerol kinase (GK) catalyzes the phosphorylation of glycerol by adenosine-
5-triphosphate (ATP) to glycerol-3-phosphate. Glycerol-3-phosphate-oxidase
oxidizes glycerol-3-phosphate to dihydroxyacetone phosphate and hydrogen
peroxide (H2O2). The catalytic action of peroxidase (POD) forms quinoneimine
from H2O2, aminoantipyrine and 4-chlorophenol. The change in absorbance
due to the formation of quinoneimine is directly proportional to the total
amount of glycerol and its precursors in the sample and is measured using a
bichromatic (510, 700 nm) endpoint technique.
Method: GPO-POD
The Linearity is 15 - 1000 mg/dl.


Serum.
QMSP 15

Plain Vial / Gel Vial / Clot Vial.

1. DIMENSION EXL 200 2. Centrifuge 3. Sample cups 4. Triglyceride reagent.

1. Temp: 200C-280C
3. Dust free.
Sample storage:
specific calibration with CHEM II Calibrator is done in the following cases:
j) Procedural steps

For internal quality assessment commercial control is run daily 2

l) Interferences
Small amounts of free glycerol may be found in blood samples from healthy
individuals due to natural lipolysis. The concentration of free glycerol may be
increased by stress, disease states or administration of intravenous infusates. Free
glycerol or other polyols may cause a positive interference.
Glycerol-based quality control products should not be used with this method.
Hemoglobin (hemolysate) of 500 mg/dL [0.31 mmol/L] (monomer) will increase a
triglycerides result of 155 mg/dL [1.75 mmol/L] by 12%.
Bilirubin (unconjugated) of 20 mg/dL [342 μmol/L] will increase a triglycerides
result of 156 mg/dL [1.76 mmol/L] by 11%.

Instrument automatically calculates the result & CV%. MU% is calculated as
CV% X 1.96.

< 150 mg/dl - Desirable
150 - 199 mg/dl - Borderline High
200 - 499 mg/dl - High
> 500 mg/dl - Very High

15-1000 mg/dl
p) TAT
Regular: 8 hrs
Emergency: 2 hrs

Sample having TG value more than 1000 mg/dl should be auto diluted and
re-run.

Not Applicable


Increased level occur in different types of hyperlipoproteinemias, liver disease,
nephritic syndrome, hypothyroidism, poorly controlled diabetes, pancreatitis,
glycogen storage disease, myocardial infarction, toxemia. Decreased level in
malnutrition and congential alpha-beta lipoproteinemia.
a. Kit Instruction.
a. Kit Literature.
26-27. Lippincort.

NAME OF TEST: HDL CHOLESTEROL
The AHDL method for the Dimension® clinical chemistry system is an in vitro
diagnostic test intended to quantitatively measure high density lipoprotein
cholesterol (HDL-C) in human serum and plasma. HDL-C measurements are
used as an aid in the diagnosis of lipid disorders.

The AHDL Cholesterol assay is a homogeneous method for directly measuring
HDL-C levels without the need for off-line pretreatment or centrifugation
steps.
The method is in a two reagent format and depends on the properties of a
unique detergent, as illustrated. This method is based on accelerating the
reaction of cholesterol oxidase (CO) with non-HDL unesterified cholesterol
and dissolving HDL selectively using a specific detergent. In the first reagent,
non-HDL unesterified cholesterol is subject to an enzyme reaction and the
peroxide generated is consumed by a peroxidase reaction with DSBmT
yielding a colorless product. The second reagent consists of a detergent
capable of solubilizing HDL specifically, cholesterol esterase (CE) and
chromagenic coupler to develop color for the quantitative determination of
HDL-C.
Accelerator + CO
HDL, LDL,
Non-reactive LDL, VLDL, Chylomicrons
VLDL,
Chylomicrons DSBmT + Peroxidase
HDL Specific
Detergent
HDL HDL disrupted
Cholesterol esterase
HDL Cholesterol ∆4 Cholestenone + H2O2
Cholesterol oxidase
Peroxidase
H2O2 + DSBmT + 4-AAP Color development
Method: ACCELERATOR SELECTIVE DETERGENT METHODOLOGY.

QMSP 15
f) Performance characteristics
The Linearity is 10.0 - 150 mg/dl.

Serum.
e) Type of container & additives


variable volume 5. Micro tips 6.HDL-cholesterol reagent.

1. Temp: 200C-280C
3. Dust free.
Sample storage:
specific calibration with AHDL Calibrator is done in the following cases:
j) Procedural steps


For internal quality assessment commercial control is run daily 2 different
l) Interferences
The AHDL method was evaluated for interference from hemolysis, icterus and
lipemia according to CLSI/NCCLS EP7-P. Bias is the difference in the results
between the control sample (without the interferent) and the test sample
(contains the interferent) expressed in percent. Bias exceeding 10% is
considered interference.
Substance Test Concentration AHDL Concentration Biasi
Tested SI Units mg/dL [mmol/L] %
Hemoglobin 1000 mg/dL 29 [0.75] < 10
(hemolysate) [0.62 mmol/L] (monomer)
Bilirubin 80 mg/dL 29 [0.75] < 10

(unconjugated) [1368 µmol/L]
Lipemia 3000 mg/dL 28 [0.73] < 10
(Intralipid® [34.29 mmol/L]

CV% X 1.96.

< 40 mg/dl(Man) - Poor
<50 mg/dl(Women) - Poor
40 - 49 mg/dl(Man) - Good
50 - 59 mg/dl(Women) - Good
≥ 60 mg/dl - Best

10.0 - 150 mg/dl
p) TAT
Regular: 8 hrs
Emergency: 2 hrs


Sample having HDL value more than 150 mg/dl should be auto diluted and
re-run.

Not Applicable

Increased values are observed in vigorous exercise, increased clearance of
Triglyceride, insulin treatment and estrogen therapy. Decreased values are
observed in stress, acute myocardial infarction, surgery, starvation,
obesity, lack of exercise, cigarette smoking, diabetes mellitus,
hypothyroidism, liver disease, nephrosis, uremia, familial hypo
alphalipoproteinemias, rare genetic disorders.
However, it should be noted that moderate increment in values is
beneficial to health.
HDL Cholesterol > 60mg% counts as negative risk factor for CHD.
a. Kit Instruction.
a. AHA Guideline
26-27. Lippincort.

NAME OF TEST: URIC ACID
The URCA method used on the Dimension ® clinical chemistry system is an in
vitro diagnostic test intended for the quantitative determination of uric acid in
human serum, plasma and urine.

Uric acid, which absorbs light at 293 nm is converted by uricase to allantoin,
which is nonabsorbing at
293 nm. The change in absorbance at 293 nm due to the disappearance of
uric acid is directly proportional to the concentration of uric acid in the
sample and is measured using a bichromatic (293, 700 nm) endpoint
technique.
Method: URICASE
Test has a linearity range of 0 – 20 mg/dl.

Serum.
QMSP 15


variable volume 5. Micro tips 7.Uric acid.


1. Temp: 200C-280C
3. Dust free.
Sample storage:
specific calibration with CHEM I Calibrator is done in the following cases:
j) Procedural steps

l) Interferences
The URCA method (using the standard sample size of 17 μL) was evaluated for
interference from hemolysis, icterus and lipemia according to CLSI/NCCLS EP7-P.
Bias, defined as the difference between the control sample (does not contain
interferent) and the test sample (contains the interferent), is shown in the table
below. Bias exceeding 10% is considered “interference”.


CV% X 1.96.

Women : 2.6 – 6.0 mg/dl
Men : 3.5 – 7.2 mg/dl

0 – 20 mg/dl
p) TAT
Regular: 8 hrs
Emergency: 2 hrs

Sample having U/A value more than 20 mg/dl should be auto diluted and re-
run.

Not Applicable
Elevated Uric Acid level may be indicative of renal insufficiency and
commonly associated with gout. Increase in level occur in excessive dietary
purines, polycythemia myeloid metaplasia, sickle cell anemia, alcohol
ingestion, ketoacidosis especially in diabetes and starvation, and excess
aspirin intake.

a. Kit Instruction.
a. Kit Literature.
26-27. Lippincort.

NAME OF TEST: PHOSPHORUS
The PHOS method is an in vitro diagnostic test for the quantitative measurement of
inorganic phosphorus in serum, plasma and urine on the Dimension® clinical chemistry
system. Measurements of phosphorus (inorganic) are used in the diagnosis and
treatment of bone, parathyroid and renal disease.

Inorganic phosphate reacts with ammonium molybdate in the presence of
sulfuric acid to form a phosphomolybdate complex which is measured at
340 nm and blanked at 700 nm.
(NH4)2MoO4 + PO4-3 (NH4)3[PO4(MoO3)12]

pH 1.1
Method
Photometric UV test with endpoint determination.
The Linearity is 0.5 – 9.0 mg/dl.

Serum.
QMSP 15


1. DIMENSION EXL 200 2. Centrifuge 3. Sample cups 4. Micro pipettes
of variable volume 5. Micro tips 6.Phosphorus.


1. Temp: 200C-280C
3. Dust free.
Sample storage:
specific calibration with CHEM II Calibrator is done in the following cases:
j) Procedural steps

For internal quality assessment commercial control is run daily 2
l) Interferences
The PHOS method was evaluated for interference according to CLSI EP07-
A2.8 Bias is the difference in results between the control sample (without
interferent) and the test sample (contains interferent) expressed in percent.
Bias exceeding 10% is considered interference.
Hemoglobin at 1000 mg/dL [0.62 mmol/L] increases PHOS results by 17% at
a phosphorus concentration of 2.5 mg/dL [0.81 mmol/L].
Lipemia (Intralipid®) at 3000 mg/dL [33.9 mmol/L] increases PHOS results
by 71% and 30% at a phosphorus concentration of 2.5 mg/dL [0.81 mmol/L]
and 6.5 mg/dL [2.1 mmol/L] respectively.
Albumin at 6.0 g/dL [60 g/L] increases PHOS results by 19% at a
concentration of 2.5 mg/dL [0.81 mmol/L].
Hemolyzed samples may give spuriously elevated phosphorus results. Bias
from hemolysis may result from inorganic phosphates produced by the action

of phosphatases on organic phosphates, both of which are released from red

blood cells upon hemolysis.

CV% X 1.96.

[mg/dL]
Adult 2.5 – 4.5
Children 4.0 – 7.0

0-9 mg/dl
p) TAT
Regular: 8 hrs
Emergency: 2 hrs

Sample having PHOS value more than 9.0 mg/dl should be auto diluted and
re-run.

< 1 mg/dl

Venous statis should be avoided during collection of blood sample.
Common contaminant of Laboratory glass wares interferes with results so
care should be taken to overcome the problem.
Elevation of values observed in diabetes mellitus, renal diseases,
hypoparathyroidism, Paget’s disease, acromegaly, dehydration, Vitamin D
intoxication, osteolytic metastatic tumour of bone and sickle cell anemia.
Hyperparathyroidism, rickets, osteomalacia, malabsorption, Vitamin D
deficiency and alcoholism lower phosphorous level.

a. Kit Instruction.
a. Kit Literature.
26-27. Lippincort.

NAME OF TEST: CALCIUM
The CA method used on the Dimension ® clinical chemistry system is an in
vitro diagnostic test intended for the quantitative determination of calcium in
human serum, plasma and urine.

Calcium reacts with OCPC to form a purple complex. The amount of complex
thus formed is proportional to the calcium concentration and is measured
using a bichromatic (577, 540 nm) endpoint technique. Magnesium ions,
which also form a colored complex with OCPC, are removed from the reaction
by complexation with 8-quinolinol.
Method: OCPC
The method has a linearity range of 5.0 – 15.0 mg/dl.

Serum.
QMSP 15


variable volume 5. Micro tips 6.Calcium cartridge.

1. Temp: 200C-280C
3. Dust free.

Sample storage:
specific calibration with CHEM I Calibrator is done in the following cases:
j) Procedural steps

l) Interferences
Interference due to magnesium is negligible at magnesium levels normally
encountered in human serum. A maximum positive interference of 0.7 mg/dL
[0.17 mmol/L] occurs at a magnesium level of 7 mg/dL [2.9 mmol/L].
Calcium values may be falsely decreased in the presence of gadolinium-
containing contrast agents such as Omniscan™. Therefore the manufacturer
of this product recommends to avoid drawing samples for serum calcium
determination 24 hours after administration of Omniscan™.
Bilirubin (unconjugated) of 80 mg/dL [1368 μmol/L] decreases calcium at 6.4
Lipemia (Intralipid®) of 600 mg/dL [6.78 mmol/L] and above tripped a test
report message; therefore the magnitude of the interference could not be
determined.
EDTA when present at 200 mg/dL [2 g/L]e and potassium oxalate when
present at 500 mg/dL [5 g/L]e depresses the CA result to less than the assay
range of the method.


CV% X 1.96.
Adult: 8.8 – 10.6 mg/dl
Children:
0 – 10 days: 7.6 – 10.4 mg/dl
10 days – 24 months: 9.0 – 11.0 mg/dl
2 – 12 year: 8.8 – 10.8 mg/dl

5-15 mg/dl
p) TAT
Regular: 8 hrs
Emergency: 2 hrs

Sample having Ca value more than 15.0 mg/dl should be auto diluted and re-
run.

< 6 mg/dl and > 13 mg/dl

Venous statis should be avoided during collection of blood sample.
Elevation of values observed in hyperparathyroidism, multiple myeloma,
neoplasm of bone and parathyroid, rapid demineralization of bone.
Hypo parathyroidism, tetany, nephrosis, pancreatitis, rickets, osteomalacia,
tropical sprue and celiac disease lower calcium level.

a. Kit Instruction.
a. Kit Literature.
26-27. Lippincort.

NAME OF TEST: GAMMA-GT
The GGT method used on the Dimension ® clinical chemistry system is an in
vitro diagnostic test intended for the quantitative determination of γ-
glutamyl transferase activity in human serum and plasma.

γ-glutamyl transferase catalyzes the transfer of the glutamyl moiety from γ-
glutamyl-3-carboxy-4-nitranilide (GCNA) to glycylglycine thereby releasing
5-amino-2-nitrobenzoate which absorbs at 405 nm. This change is
proportional to the γ-glutamyl transferase activity and is measured using a
bichromatic (405, 600 nm) rate technique.
Method: SZASZ method.
c) Analytical measuring range

The Linearity is 0 – 800 U/L
The analytical sensitivity represents the lowest activity of GGT that can be
distinguished from zero.

Serum.
QMSP 15


1. DIMENSION EXL 200 2. Centrifuge 3. Sample container 4.
Micropipettes of variable volume, 5. Tips, 6. GGT.


1. Temp: 200C-280C
3. Dust free.
Sample storage:
j) Procedural steps


l) Interferences
Hemolysis (hemolysate) of 500 mg/dL [0.31 mmol/L]f(monomer) and above
tripped a test report message; therefore the magnitude of the interference
could not be determined.
Bilirubin (unconjugated) of 60 mg/dL [1024 μmol/L] and above tripped a test
report message; therefore the magnitude of the interference could not be
determined.
Triglycerides as (Intralipid®) of 200 mg/dL [2.299 mmol/L] decreases a GGT
at 128 U/L by 16%.
CV% X 1.96.
Male : < 55 U/L
Female: < 38 U/L
Children: Male Female
1 – 182 days 12 – 122 U/L 15 – 132 U/L
183 – 365 days 1 – 39 U/L 1 – 39 U/L
1 – 12 years 3 – 22 U/L 4 – 22 U/L
13 – 18 years 2 – 42 U/L 4 – 24 U/L
0-800 U/L
p) TAT
Regular: 8 hrs
Emergency: 2 hrs
Sample having GGT value more than 800 U/L should be auto diluted and re-
run.
Not Applicable


Increase in enzyme activity is observed in various hepatobiliary diseases

and pancreatitis, acute myocardial infarction, heavy use of alcohol,
carcinoma of breast and lung, neoplasms and carcinoma of prostate.
a. Kit Instruction.
a. Kit Literature.
26-27. Lippincort.

NAME OF TEST: LDL CHOLESTEROL
The ALDL method for the Dimension® clinical chemistry system is an in vitro
diagnostic test intended for the quantitative determination of low-density
lipoprotein cholesterol (LDL-C) in human serum and plasma.
LDL-C measurements are used in the diagnosis and treatment of lipid
disorders such as diabetes mellitus, atherosclerosis, and various liver and
renal diseases.

The ALDL Cholesterol assay is a homogeneous method for directly measuring
LDL-C levels in human serum or plasma, without the need for any off-line
pretreatment or centrifugation steps.
The method is in a two reagent format and depends on the properties of
detergent 1 which solubilizes only non- LDL particles. Cholesterol released is
consumed by cholesterol esterase and cholesterol oxidase in a non-color
forming reaction. Detergent 2 solubilizes the remaining LDL particles. The
soluble LDL-C is then oxidized by the action of cholesterol esterase and
cholesterol oxidase forming cholestenone and hydrogen peroxide (H 2O2). The
enzymatic action of peroxidase on H2O2 produces color in the presence of N,N-
bis(4-sulfobutyl)-m-toluidine, disodium salt (DSBmT) and 4- aminoantipyrine
(4-AA) that is measured using a bichromatic (540, 700 nm) endpoint
technique. The color produced is directly proportional to the amount of LDL-C
present in the sample.

Method
Direct Homogeneous Enzymatic Colorimetric (Without Precipitation)
Test has a linearity range of 5 - 300 mg/dl
The sensitivity of the ALDL method is 5 mg/dL and represents the lowest
concentration of LDL-C that can be distinguished from zero.

Serum.
QMSP 15


1. DIMENSION EXL 200 2. Centrifuge, 3. Sample rack, 4. Micropipettes of
variable volume, 5. Micro Tips, 6. LDL Kit.

1. Temp: 200C-280C
3. Dust free.
Sample storage:
j) Procedural steps


l) Interferences
Bilirubin (unconjugated) of 80 mg/dL [1368 μmol/L] will decrease an ALDL
result of 124 mg/dL
[3.2 mmol/L] by 10%.
Lipemia (Intralipid®) of 3000 mg/dL[33.9 mmol/L] will decrease an ALDL
result of 122 mg/dL [3.2 mmol/L] by 19%.

CV% X 1.96.

< 100 mg/dl - Ideal for people at risk
of heart disease
100 - 129 mg/dl - Near ideal
130 - 159 mg/dl - Borderline High
160 - 189 mg/dl - High
≥ 190 mg/dl - Very High

NA
p) TAT
Regular: 8 hrs
Emergency: 2 hrs

Sample having LDL value more than 300 mg/dl should be auto diluted and
re-run.


As described in chapter VI.

LDL’s constitute about 50% of the total lipoprotein mass in human plasma.
The particles are much smaller than the triglyceride – rich lipoprotein, and
even greatly increased concentration of LDL don’t scatter light or alter the
clarity of plasma. cholesterol most of it esterified, accounts for about half of
LDL mass. About 25% of LDL mass is protein, mostly apoB - 100 with traces
os apoC.
Discrete of LDL have been identified that differ somewhat in their size and
chemical composition this smaller species of LDL contain lower amount of
Cholesterol ester, result in a lower cholesterol / apoB ration in this particles
than in larger species of LDL. Increased amount of the smaller particles have
been found in patient with several common forms of dyslipoproteinemia that
are associated with coronary artery disease.
u) Reference:
a. Kit Instruction.
a. AHA Guideline
26-27. Lippincort.

SODIUM, POTASSIUM AND CHLORIDE
a. Purpose of examination:
Estimation of Serum Sodium, Potassium and Chloride
b. Principle of the Procedure used for Examination:

Indirect measurement by Integrated Multisensor Technology (IMT).
There are five electrodes used to measure electrolytes on the dimension system.Three of these
electrodes are incorporated into the QuickLYTE IMT and are Ion selective for Sodium,Potassium
and Chloride.A reference electrode is also incorporated in the multisensor. After a diluted sample
is positioned in the sensor,Sodium,Potassium and Chloride ions establish an equilibrium with the
electrode surface.A potential is generated proportional to the logarithm of the analyte activity in
the sample.The electrical potential generated on a sample is compared to the electrical potential
generated on a standard solution and the concentration of the desired ions is calculated by the
use of Nernst equation.
c. Performance specifications:
Test is measurable from detection limit:
Sodium: 20 – 200 mEq/L.
Potasium: 1 – 10 mEq/L.
Chloride: 25 – 200 mEq/L.
d. Primary Sample System:

Clotted Serum .
e. PATIENT PREPARATION: Refer to QMSP/15.
f. Type of container & additives:

Clotted gel vial.
g. Required equipment and reagents:

1. EXL 200
2. Centrifuge
3. Clotted vial
4. Siemens Reagent-QuikLYTE
h. ENVIRONMENTAL AND SAFETY CONTROL

1. Temp: 20 0C-25 0C 5. Water Quality
2. Humidity: not more than 80%-90 % 6. Stability of Power Supply
3. Absolutely dust free.
4. Wrong sampling.

SAMPLE STORAGE:
i. Calibration procedure:
The dimension are IMT system will routinely perform a one point calibration with each sample
measurement.In addition,the system performs as two point automatic calibration in duplicate
every two hours,if no analysis is in progress.Auto calibration also occurs shortly after turn
on,with the changing of standards A,B or a sensor and when reset.Calibration can be initiated at
any time a sample is not being run.
j. PREANALYTICAL PROCEDURE/ OPERATION OF THE INSTRUMENT

 Blood is collected using standard laboratory procedures
 3.0 ml of whole blood for plasma preparation is collected in sodium fluoride vial.
 Whole blood in sodium fluoride vial is centrifuged at 3000 rpm for 5 minutes for Plasma
separation.
 Bar-coded primary tubes are processed in the analyser.
TESTING PROCEDURE:- Testing procedure is automatically performed by the analyser.
OPERATION OF INSTRUMENT
Sample is collected, processed as per requirement and then the examination is carried out
following the operating procedure as described in chapter –II.
k. Quality Control Procedure:

For internal quality assessment 2 level commercial controls from Biorad is run. The laboratory
participates in Biorad EQAS monthly clinical chemistry. Detailed Quality control procedure is
described in Chapter – III.
l. Interferences:
Clots and fibrin interfere.Prolonged tourniquet use and hand exercise when drawing blood falsely
increase potassium level. Na2EDTA as anticoagulant may interfere
m. PRINCIPLE OF PROCEDURE FOR CALCULATING RESULTS INCLUDING, WHERE

RELEVANT, THE MEASUREMENT UNCERTAINTY OF MEASURED QUANTITY VALUES
Instrument automatically calculates the result.
CV%/MU% is calculated from internal QC data.
n. REPORTABLE INTERVAL OF EXAMINATION RESULTS:

Sodium: 20 – 200 mEq/L.
Potasium: 1 – 10 mEq/L.
Chloride: 25 – 200 mEq/L.

o. TAT
Regular timing for reporting is 8 hrs.
Emergency – 2 hrs.
p. Biological Reference intervals:

Sodium: 136– 145 mmol/L.

Potassium: 3.5-5.1 mmol/L

Chloride : 98-107 mmol/L
q. INSTRUCTIONS FOR DETERMINING QUANTITATIVE RESULTS WHEN A RESULT IS NOT

WITHIN THE MEASUREMENT INTERVAL:
Auto rerun facility is there in the instrument if it crosses the reagent linearity and also upon
pathologists discretion.
r. Alert/Critical values, where applicable:

Sodium < 120 mmol/L, > 160 mmol/L
Potassium <2 mmol/L, > 6.0 mmol/L
s. Laboratory interpretation:
Sodium-as hypo and hypernatremia,
Potassium-as hypo and hyperkalemia
t. Potential source of variability:

Potassium: Demographic variations and diseased conditions.
Increased level is observed in adreno cotical insufficiency, diabetic acidosis, acute respiratory
acidosis, acute renal failure. Decreased level is observed in diarrhea, pyloric obstruction,
starvation, malabsorption, hyper aldosteronism, chronic renal failure, excessive sweating, burns,
leukemia and hyperthyroidism.
Sodium: Demographic variations and diseased conditions.

Increased level is observed in dehydration, primary aldosteronism, hyperglycemia, diabetes
insipidus, diabetic ketoacidosis. Decreased level is observed in congestive heart failure, excessive
sweating, diarrhea, pyloric obstruction, malabsorption, burns, adreno cortical insufficiency, renal
tubular acidosis, chronic and acute renal failure, cirrhosis, nephrotic syndrome.
Chloride: Demographic variations and diseased conditions.

Hypochloremia is observed in chronic pyelonephritis, metabolic acidosis, renal failure and
prolonged vomiting. Hyperchloremia is observed in dyhydration, renal tubular acidosis, acute
renal failure, metabolic acidosis with diarrhea, respiratory alkalosis, congestive heart failure.
In CSF, decreased value is observed in coccal meningitis, tubercular meningitis; raised level is
observed in hyper tension and renal diseases.
Lowering of serum chloride level is reflected in CSF chloride.
u. Reference: Kit Literature

Doc No. RKLS/SOP/01 SOP BIOCHEMISTRY CHAPTER - II
MACHINE OPERATING PROCEDURE

A. Start Up
Step 1:
If the instrument is unplugged, plug the power cord into the wall outlet.
Step 2.
Open the left front instrument door and turn on the main instrument power switch.
Wait until the Operating Menu display appears on the screen.
Step 2
After initialization is complete, you should perform the Daily Maintenance procedure.
You should wait until the instrument reaches proper operating temperatures before
performing the system check porting of daily maintenance.
Step 3
After completing daily maintenance, you need to run your laboratory’s daily QC
procedures to ensure the system is operating properly.
NOTE : IMT will automatically calibrate.
B. Sample processing for
Instructions for processing Sample
Bar Coded Tubes-
1. Place the bar-coded sample on a segment in the appropriate adaptor 10 ml tubes
may be put directly in segment with the bar code facing the bar code reader.7 ml
and 5 ml tubes must be placed in appropriate adaptors . Beige adaptors are for
7ml tubes ; teal adaptors are for 5 ml tubes . Check for sufficient sample volumes
using the tube fill gauge .
2. Short bar-coded tube samples can be transferred into the clear plastic small
sample containers (SSC) . Place sample into available position in SSC designated
segment . Place SS atop barcoded tube. Ensure the barcode label is visible in the
opening of the segment .
3. Non –bar-coded samples can be put in plastic sample cups and place in either
beige or teal adaptors . Enter patient information manually .
4. Urine and CSF specimens can be processed in sample cups . patient information
must be entered manually .
5. manually Entering patient Information :

From main operating menu, press F1 : Enter data.

POSITION Enter segment letter and position number
PATIENT NAME Enter name (if applicable)
SAMPLE NO Enter patient accession number (if applicable
) LOCATION Enter optional
TEST Select test by pressing method keys on keyboard.
F7 : Mode Select the sample container you are using . Sample
cup primary tube, SSC ,etc.
F4 : PRIORITY Routine ,stat, etc .
DILUTION Enter dilution factor (if applicable)
F8 : FLUID Serum , urine , plasma or csf.
I. To run single specimen, enter the patients information . place the specimen in the
segment position you have selected , press F2 : process Single .
II. If you have more than one sample to enter manually , press F1 new Sample
after each entry . After entering all samples, press F3 Load list place samples in
the designated segment positions, press RUN.
III. Segment that are in use are highlighted in red at the top of the screen. Any
segments in red should not be taken of the instrument .
IV. To initiate processing of down loaded sample: .
 From Sample Status screen move cursor to double asterisked sample
. The cursor will change to a box.
 Enter segment position for the sample .
 Press enter
 Load barcoded samples
 Press Run.
V Other instructions :
 View calibration preparation conditions and expiration date on the package
insert sheet of calibration product . For lyophilized products ,the preparation
steps must be followed precisely .

 Review the instrument maintenance logs and the System counter screen for any
maintenance that may be overdue. Check the system count for the sample probe
tip, especially if the problem is on a method with a low sample volume.
 Check that all temperatures are within range on the Daily maintenance screen.
Check the temperatures with a calibrated thermometer according to the
“Calibration Cuvettes system Temperature” “Calibration range system
Temperature “and “Calibration HM module Temperature” procedures in your
operator’s guide.
 If any data point are missing due to a process error.
1. For logit methods, you must reject the calibration

2. For linear methods, up to three data points can be missing as long as there is
at least one data point for each level. If the calibration meets the criteria, it can
be accepted.
C. Shut Down :
Step 1.
After Pump prime step is completed, wait until the system is in STANBY status.
From the operating menu display, press the EXIT key two times.
The system will display the following message:
“Do you really want to exit? (Hit “EXIT” to confirm, “RETURN” to continue)”
Step 2
Press the EXIT key. The system will the following message.
‘If you really want to shut down the system down, type ‘y’.”
Step 3
Press y. The system will make a backup copy of all important data to the disks.
Step 4
Wait until both disk drive lights are stay off, and the message “ Rhug;” appears on
the computer display screen.
Step 5
Open the left front instrument door and turn off the main instrument power switch.
Dimension

A. Start up Procedure for Dimension:

Switching on the analyzer
Start the application software, and Wait for the 15 sec. then switch on the analyser.
Or Switch on the analyser, Wait for one minute, then start the application software
↓
Click the button Maintenance
↓
Click the button of cuvette rinse and check absorbance of cuvettes
To go back to Main Menu
↓
Sample Processor
B. Sample processing for DIMENSION
1.) Clicking on the <Patient Entry> button on the main menu screen, patient ID &
patient name’s whose test to be performed are click <Save>.
↓
2.) Click the <Work list> icon on the screen of ‘Patient Entry’. The work list includes
the following details in the form of chart: Disk No., Sample position, Test name,
Replicates, Run type and Sample volume type. And the Work list is assigned for
each Patient.
↓
3.) Information related to sample & reagent bar codes (optional) and reagent volume
& stability is displayed on this screen. The details about the options available on
this screen are explained in the sub-sections.
↓
4.) Clicking on the <Run Monitor> button on the [Run Test : Run Status] screen,
analysis of the sample is run by clicking on <Start Pat Run>.
↓
5.) To assign STAT priority: Samples are programmed during run at E1 to E20
position after selecting the emergency position for the sample.
↓
6.) Sample added during the run will be analysed giving priority over the routine
sample.

C. Shut
Down Go back to main Menu
↓
Go back to maintenance & Start water save procedure
↓
Go to Exit & Shut Down the Windows
↓
Switch Off

Doc No. RKLS/SOP/01 SOP BIOCHEMISTRY CHAPTER - III
QUALITY CONTROL PROCEDURE:

Purpose:
Quality control (QC) is concerned with the analytical phase of QA. The purpose
of this document is to monitor the overall reliability and monitoring the validity
of laboratory results.
Scope:
All routine biochemical tests under the scope of Accreditation
RESPONSIBILITY: Consultant Pathologist
Following Procedure is followed in Biochemistry.

A. Regular use of QC material of renowned QC kit manufacturer
B. Participation in EQAS / inter-laboratory comparison
C. Retesting of retained sample
D. Correlations of results
A. Regular use of QC material of renowned QC kit manufacturer:

Laboratory runs QC as per Quality Control Plan (RKLS/FM/70) i.e. daily two level of control for all
the parameters under scope. Laboratory interprets QC results by using statistical technique such
as L-J chart. Where any parameter value is found to deviate Westgard Multi QC rules, cause is
identified & corrective action is taken. Consultant reviews it and records are maintained
accordingly.
Calculation of CV %: The standard deviation (SD) of a set of results divided by the mean result is
expressed as a percentage CV. In automated analyzer percentage CV is auto calculated along with
L-J chart.
GENERAL PROCEDURE AND TERMINOLOGY:

Running commercial control:
Dimension EXL 200

Two level controls are run once daily for all of the parameters

PROCEDURE FOR HANDLING INTERNAL COMMERCIAL CONTROL:
 Receive the sample and confirm Lot No and Expiry Date with reference values specific to
the machine.
 Make a note of the storage temperature.
 Controls are stored at 2-8oC in specified Biochemistry Refrigerator
 Vials are kept at room temperature for a maximum period of 1 hour while running tests.
 Record sample validity period after opening or reconstitution.
 Prepare aliquots (if applicable) and store in recommended temperature.
 Internal Controls are run on a daily basis immediately after the specific machines are switched
on and in perfect running mode. Only authorized personnel in each department run controls.
 Values observed are recorded and plotted in L-J charts.
 Observe for any violation of Multi QC Deviation Rule and proceed accordingly.
INTERPRETATION OF QUALITY CONTROL DATA
QC Results are reviewed & if any of the parameters run out of 2SD or do not follow any of the MULTI
QC RULES described below, then a QC Level is run for the second time. If the results still do not fall
within the expected range, then the test parameter is calibrated, QC checked & samples run. All the
QC values are checked and filed and reviewed by the Consultant Pathologist.

The rules to follow when 1 level QC material are used:

Reject QC if:
13S: One control observation exceeding the mean ± 3s; primarily sensitive to random error.
22S: Two consecutive control observation exceeding the same mean plus 2 s or mean minus 2 s
limit; sensitive to systematic error.
10X: 10 consecutive control observations falling on one side of the mean (above or below, with no
other requirement on size of the deviations); sensitive to systematic error.
41s: Four consecutive values on either side of mean are within 1SD to 2SD (41S).
The rules to follow when 2 level QC material are used:

Reject QC if:
1.
Either QC value is outside 3 SD (1 3 S)
2.
Both QC value are outside 2 SD on the same side, but within 3 SD (2 2 S)
3.
Different between both QC value is > 4 SD i.e. one level QC is > 2 SD and other level QC is
<2SD (R 4 S)
4.
Ten consecutive value of the same level QC are >/< the mean, but within 2 SD (10x)
5.
Five consecutive value of one level QC and five consecutive value of another level QC are
>/< the mean but within 2 SD (10x).
6.
Four consecutive values on either side of mean are within 1SD to 2SD
Procedure to be followed when QC results are “out of control” (> ± 2 SD).
FOLLOW STEP WISE TILL QC RESULTS ARE “IN CONTROL”

1. Repeat with same aliquot of QC.
2. Repeat with new aliquot of QC.
3. Reconstitute new QC.
4. Calibrate with current calibration pack and same reagent.
5. Calibrate with new calibration pack and same reagent.
6. Check generation no. of slide/ lot no. Cartridge/ reagent expiry / on board reagent expiry.
7. Use new reagent.
8. Calibrate with new calibration pack and new reagent
9. Contact respective Application Specialist.

B. Participation in EQAS / Inter-Laboratory Comparison:

The laboratory participates in EQAS with Bio-Rad. Before testing of EQAS sample daily QC results
are reviewed, if results are found satisfactory then EQAS sample is tested. ILC is done with NABL
accredited labs once in a month.
C. Retesting of retained sample:

Retesting of the sample is done daily. Primary sample is chosen at a random and tested within 24
hrs. Consultant Pathologist reviews retesting results and record is maintained.
D. Correlations of results:
Different Tests when results indicate the same pathology are used to confirm test results when
necessary. Both inter and intradepartmental correlation is done. Pathologist reviews the record

Doc No. RKLS/SOP/01 SOP BIOCHEMISTRY CHAPTER - IV
CALIBRATION PROCEDURE
EXL 200
 Machine is calibrated by the manufacturer as and when required
 Individual parameter calibration is done in-house by calibrators having
international traceability.

Doc No. RKLS/SOP/01 SOP BIOCHEMISTRY CHAPTER - V
SAFETY AND PRECAUTIONS PROCEDURE:
 Safety instructions of different instruments and chemicals given by manufacturers

are followed strictly.
 General safety precautions of biohazard are observed.
 Samples are handled with utmost care.
 Samples are handled wearing gloves, facemask and apron.
 Reagents and chemicals are kept according to the company instructions
Issue No. 03 Issue Date: 11.09.2014 Prepared By: QM Copy No. Page 1 of 1
Rev. No.: 01 Rev. Date: 18.08.2022 Approved By: LD Issued By: QM

Doc No. RKLS/SOP/01 SOP BIOCHEMISTRY CHAPTER - VI
List of Critical Alert Value

SL NO TEST DISCIPLINE TEST PARAMETER CRITICAL VALUE
1. Biochemistry Glucose Adult: <40 mg/dl
>450 mg/dl
Newborn: <30 mg/dl
> 300mg/dl
2. Biochemistry Amylase > 700 U/L
3. Biochemistry Bilirubin Newborn : > 15 mg/dl
4. Biochemistry Calcium (T) < 6 mg/dl

> 13 mg/dl
5. Biochemistry Lipase > 700 U/L
6. Biochemistry Creatinine > 5 mg/dl

7. Biochemistry Urea > 175 mg/dl
8. Biochemistry Sodium < 120 mmol/L

> 160 mmol/L
9. Biochemistry Potassium > 6.0 mmol/L
< 2.5 mmol/L
10. Biochemistry Chloride <80 mEq/L, > 115mEq/L
11. Biochemistry BUN 2 mg/dL, >80 mg/dL
Ref: Wallsch. J interpretation of diagnostic test 7th edition page 29-31. Lippincort

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Doc No. RKLS/SOP/01 SOP BIOCHEMISTRY

COPY NO: MASTER COPY

HOLDER: QUALITY MANAGER

ISSUE DATE: 09.03.2020

Rev. No.: 01 Rev. Date: 18.08.2022 Approved By: Issued By

Doc No. RKLS/SOP/01 SOP BIOCHEMISTRY

Sl. Page Section/ Date of Amendment Reasons Signature Signature

Issue No. 04 Issue Date:09.03.2020 Prepared By: Copy No. Page 1 of 1

Rev. No.: 00 Rev. Date: Nil Approved By: Issued By

Doc No. RKLS/SOP/01 SOP BIOCHEMISTRY

Rev. No.: 00 Rev. Date: Nil Approved By: Issued By:

Doc No. RKLS/SOP/01 SOP BIOCHEMISTRY

III QUALITY CONTROL PROCEDURE 00 00 1–4

IV CALIBRATION PROCEDURE 00 00 1–1

VI LIST OF CRITICAL ALERT VALUE 00 00 1–1

Rev. No.: 00 Rev. Date: Nil Approved By: Issued By:

NAME OF TEST: GLUCOSE

b) Principle of the Procedure used for Examination

d) Primary Sample System

Rev. No.: 00 Rev. Date: Nil Approved By: Issued By

f) Type of container & additives

g) Required equipment and reagents

h) Environmental and safety controls

k) Quality Control Procedure

Rev. No.: 00 Rev. Date: Nil Approved By: Issued By

Lipemia (Intralipid®) at 200 mg/dL [2.29 mmol/L] increases a GLUC result at 50

m) Principle of Procedure for calculating result including, relevant, the

n) Biological Reference intervals or clinical decision values:

o) Reportable interval of examination results

q) Instruction for determining quantitative results when a result is not

Rev. No.: 00 Rev. Date: Nil Approved By: Issued By

r) Alert/Critical values, where applicable

s) Laboratory clinical interpretation:

t) Potential source of variability

Rev. No.: 00 Rev. Date: Nil Approved By: Issued By

NAME OF TEST: UREA/BUN

b) Principle of the Procedure used for Examination

Method: UREASE/ GLDH

Analytical Sensitivity: 1 mg/dL

d) Primary Sample System

f) Type of container & additives

Rev. No.: 00 Rev. Date: Nil Approved By: Issued By

g) Required equipment and reagents

h) Environmental and safety controls

k) Quality Control Procedure

Rev. No.: 00 Rev. Date: Nil Approved By: Issued By

m) Principle of Procedure for calculating result including, relevant, the

s) Laboratory clinical interpretation:

t) Potential source of variability

Rev. No.: 00 Rev. Date: Nil Approved By: Issued By

NAME OF TEST: CREATININE

b) Principle of the Procedure used for Examination

Method: Kinetic Jaffe

Analytical Sensitivity: 0.05 mg/dL.

d) Type of Sample: Serum.

e) Patient preparation: QMSP 15

f) Type of container & additives