Avitex CRP CE Globe A5 V4

AVITEX CRP Ref OD073/OD023/OD023/E
Latex serology test for detection of C-Reactive Protein

o
o
Store at 2 C to 8 C. DO NOT FREEZE.
For in-vitro diagnostic use only.
INTRODUCTION AND INTENDED USE
STORAGE
AVITEX CRP is a rapid latex agglutination test kit for

the detection of C-Reactive Protein in human serum.
C-Reactive Protein (CRP) in patients sera has been
found in association with acute infections, necrotic
conditions and a variety of inflammatory disorders.
There is a strong correlation between serum levels of
CRP and the onset of the inflammatory process.
Monitoring the levels of CRP in patients sera
indicates the effectiveness of treatment and the
assessment of patient recovery.
For professional use only.
Reagents must be stored at temperatures between 2oC

o
to 8 C.
PRINCIPLE OF THE TEST
DO NOT FREEZE ANY OF THE REAGENTS as this

will cause irreversible damage.
The AVITEX CRP latex particles are coated with

antibodies to human CRP, as described by Singer et
al. When the latex suspension is mixed with serum
containing elevated CRP levels on a slide, clear
agglutination is seen within 2 minutes.
st
Calibrated against the 1 International Standard 1986
85/506
CONTENTS
The kit will perform within specification until the stated

expiry date as determined from date of product
manufacture and stated on kit and components. Expiry
date is the last day of the month on the bottle and the
kit label. Do not use reagents after the expiry date.
Exposure of reagents to excessive temperatures should
be avoided. Do not expose to direct sunlight.
SPECIMEN COLLECTION
Obtain a sample of venous blood from the patient and
allow a clot to form and retract. Centrifuge clotted
blood sample and collect clear serum. Fresh serum
samples are required.
Do not use haemolysed, contaminated or lipaemic
serum for testing as this will adversly affect the results.
Ref
OD073
Ref
OD023
Ref
OD023/E
LATEX
Suspension of polystyrene latex ( approximately 1%)
particles coated with Anti-CRP antibodies. Working
Strength.
CONTROL
+
0.5ml
0.5ml
N/A
Positive Control. Serum containing CRP antibodies.
Working Strength.
CONTROL
0.5ml 0.5ml
N/A
Negative Control. Serum free of CRP antibodies.
Working Strength.
STIRRERS
50
PLASTIC SLIDE
1
INSTRUCTION LEAFLET 1
100
1
1
N/A
N/A
1
MATERIAL REQUIRED BUT NOT PROVIDED

Micro-pipettes capable of dispensing 50l.
Isotonic saline (0.9% NaCI)
PRECAUTIONS
AVITEX CRP reagents contain materials of human
origin which have been tested and confirmed
negative for HCV, HIV I and HIV II antibodies, and
HBsAg by FDA approved procedures. Because no
test can offer complete assurance that products
derived from human source will not transmit infectious
agents it is recommended that the reagents within
this kit be handled with due care and attention during
use and disposal. All reagents should, however, be
treated as potential biohazards in use and for
disposal. Do not ingest.
AVITEX CRP Reagents do not contain dangerous
substances as defined by current UK Chemicals
(Hazardous Information and Packaging for Supply)
regulations. All reagents should, however, be treated
as potential biohazards in use and disposal. Final
disposal must be in accordance with local legislation.
AVITEX reagents contain 0.095% sodium azide as a
preservative which may be toxic if ingested. Sodium
azide may react with lead and copper plumbing to
form highly explosive salts. On disposal, flush with
large quantities of water.
Serum may be stored at 2oC to 8oC for up to 48 hours

prior to testing. If longer storage is required, store at
20oC for up to 6 weeks. Thawed samples must be
mixed prior to testing.
Do not repeatedly freeze-thaw the specimens as this
will cause false results.
DO NOT DILUTE THE PATIENT SERUM PRIOR TO
USE IN THE QUALITATIVE TEST.
REAGENT PREPARATION
All reagents should be brought to room temperature
(20oC to 25oC) and mixed gently to resuspend latex
prior to use. Do not induce foaming.
The test slide should be thoroughly cleaned before use
as traces of detergent or prior specimen may affect the
result.
Recommended Cleaning procedure:
1.
Used cards must be immediately immersed in
a disinfectant solution. Follow disinfectant
manufactures guidelines.
2.
The reaction circles must be physically rubbed
with non-abrasive material to ensure removal
of possible adhering particles.
3.
Thoroughly rinse in purified water.
4.
Allow reaction card to dry.
5.
Spray cards with a 70% alcohol solution.
6.
Allow the alcohol to evaporate prior to re-use.
LIMITATIONS OF USE
The use of samples other than serum has not been
validated in this test.
There is no reuse protocol for this product.
A low or suspected positive result should be reassessed. Diagnosis should not be made solely on the
findings of one clinical assay. When making an
interpretation of the test it is strongly advised to take all
clinical data into consideration.
Most normal, healthy humans have serum CRP
concentrations of less than 6mg/litre.
In patients with high serum concentrations continued
monitoring of the CRP levels can give a good indication
of patient response to therapy during inflammatory
disorders.
ASSAY PROCEDURE
Qualitative Method
1.
Allow kit reagents and patient serum to come to room temperature.
2.
Transfer one drop (50l) of patients serum to the test circle on the slide.
3.
Shake the latex reagent, then using the dropper provided, add one drop of
suspension to the test circle.
4.
Mix the drops using a disposable stirrer ensuring coverage of the test circle
with the mixture.
5.
Gently and evenly, rock and rotate the test slide for 2 minutes whilst
examining the test slide for agglutination.
TROUBLESHOOTING
Use a separate disposable tip for each sample to prevent cross contamination.
Replace caps on all reagents immediately after use.
Prior to the start of the assay bring all reagents to room temperature (20oC to 25oC).
Gently mix all reagents by gentle inversion or swirling.
For use by operatives with at least a minimum of basic laboratory training.
Do not use damaged or contaminated kit components.
Semi Quantitative Method

1.
Using isotonic saline prepare serial dilutions of the patients serum (1/2, 1/4,
1/8, 1/16, 1/32, 1/64 and so on)
2.
Transfer one drop (50l) of each serum dilution to the test circle on the slide.
3.
Shake the latex reagent, then using the dropper provided, add one drop of
suspension to the test circle.
4.
Mix the drops using a disposable stirrer ensuring coverage of the test circle
with the mixture.
5.
Gently and evenly, rock and rotate the test slide for 2 minutes whilst
examining the test slide for agglutination.
RESULTS AND INTERPRETATION
Examine the test slide under a strong light source after 2 minutes. Kit controls or
known level value samples should be tested with each test run. The kit negative
control should give a negative result after 2 minutes. The kit positive control should
give a positive result at a titre of 1/4 +/- one double dilution after 2 minutes. If levels
of controls or users known samples do not give expected results, test results must be
considered invalid.
Qualitative Method
A positive result is indicated by the obvious agglutination pattern of the latex, in a
clear solution. A negative result is indicated by no change in the latex suspension on
the test slide.
EVALUATION DATA
Reproducability of AVITEX CRP is 100% (+/- one double dilution).
Avitex CRP
CRP +
CRP -
+
31
0
31
Totals
0
69
69
Sensitivity 31/31 = 100%

Specificty 69/69 = 100%
REFERENCES
1.
2.
3.
4.
Anderson H.C., McCarthy M., Am. J. Med., 8 : 445 (1950).

Ward A.N., Cooper E.M., Clin Chem. Acta, 81, 75 (1975).
Fisher C.L., Nakamura R., Am. J. Clin. Path., 66, 840 (1976).
Connell E.B., Connell J., Am. J. Obs. Gynaec., 110, 633 (1971).
8008A Issue 4 Revised May 2005.

Omega Diagnostics Ltd 2005.
AVITEX CRP has a detection limit of 6mg/Litre of CRP in the patients serum.
Positive results will be obtained at a CRP serum concentration above 6mg/Litre and
negative results will be obtained at 6mg/Litre and below.
Semi-Quantitative Method
The serum CRP concentration can then be calculated approximately by multiplying
the dilution factor (i.e 2, 4, 8 or 16) by the detection limit, i.e. 6, to give the number of
mg/Litre concentration e.g. if the agglutination titre appears at 1/8 the approximate
serum CRP concentration is 8 x 6 = 48 mg/Litre.
Titres of 500 mg/Litre have been detected with Avitex CRP with no prozone ( hook )
effect.
OMEGA DIAGNOSTICS LTD.

Omega House, Hillfoots Business Village
Alva FK12 5DQ, Scotland, United Kingdom
[email protected]
www.omegadiagnostics.com
AN ISO 9001 AND ISO 13485 CERTIFIED COMPANY
31
69
100

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AVITEX CRP Ref OD073/OD023/OD023/E

Latex serology test for detection of C-Reactive Protein

AVITEX CRP is a rapid latex agglutination test kit for

Reagents must be stored at temperatures between 2oC

PRINCIPLE OF THE TEST

DO NOT FREEZE ANY OF THE REAGENTS as this

The AVITEX CRP latex particles are coated with

The kit will perform within specification until the stated

MATERIAL REQUIRED BUT NOT PROVIDED

Serum may be stored at 2oC to 8oC for up to 48 hours

Semi Quantitative Method

Sensitivity 31/31 = 100%

Anderson H.C., McCarthy M., Am. J. Med., 8 : 445 (1950).

8008A Issue 4 Revised May 2005.

OMEGA DIAGNOSTICS LTD.

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