Pro4-9 Ureez 11
Pro4-9 Ureez 11
Pro4-9 Ureez 11
DIAGNOSTIC USE
Urea is the end product of protein metabolism. It is produced in the liver and eliminated QUALITY CONTROL
from the blood in the kidneys Urea determination, together with that of creatinine, allows Control serum, Seriscann Normal (Ref. 994148/996571) and Seriscann Anormal (Ref.
assessing kidney function. 994685/999329) should be included in each test series. It is recommended to calibrate
Usually the elevated levels of blood urea reflect some alteration of the excretory function of
the kidney. This increase may also be due to poor liver function, cardiac failure or diet itself. AUTOANALYZERS
Dehydration and bleeding can raise levels of blood urea. Adaptations to different autoanalyzers are available on request.
Single test result could not be used to make a clinical diagnosis. It should integrate clinical
and laboratory data. PROCEDURE
REAGENTS
Kit 5 x 100 mL. (Ref.99 36 48). Contents: Techique BL mL SA mL ST mL
A. 5 x 100 mL Urease/salicylate Ref. 99 21 04
B. 1 x 15 mL Alkaline hypochlorite Ref. 99 14 75 Standard -- -- 0.01
C. 1 x 5 mL Standard Ref. 99 02 41 Sample -- 0.01 --
D. White polyethylene bottle 100mL Ref. 99 70 73
Kit 2 x 50 mL. (Ref.99 70 71). Contents: Reagent A 1.00 1.00 1.00
A. 2 x 50 mL Urease/salicylate Ref. 99 70 72
Mix well and incubate 3 min/37ºC or 5 min at room temperature
B. 1 x 3 mL Alkaline hypochlorite Ref. 99 70 74
(20-25ºC).
C. 1 x 5 mL Standard Ref. 99 02 41
D. White polyethylene bottle 100mL Ref. 99 70 73 Reagent B 1.00 1.00 1.00
Mix well and incubate again 3 min/37ºC or 5 min at room temperature
WORKING REAGENT PREPARATION
(20-25ºC).
Ref 99 36 48:
Vial A. Pour the contents of the urease/salicylate vial into the bottle. Add while softly stirring,
Lecture
100 mL of deionized water.
Wavelength: 578 nm; 600 nm
Vial B. Dilute the contents of the alkaline hypochlorite vial up to 500 mL with deionized
Blank: The contents of the BL tube
water.
Colour stability: 4 hours
Vial C. Standard is ready to use.
Ref 99 70 71: CALCULATIONS
Vial A. Add 50mL of deionized water softly stirring in each vial until completely dissolution. SA Abs
Vial B. Pour the content of the alkalyne hypochlorite vial into the plastic bottle and add x 40 = mg urea/dL
deionized water up to 100mL. ST Abs
Vial C. Standard is ready to use.
Where:
SA Abs: Sample absorbance
ST Abs: Standard absorbance
REAGENTS COMPOSITION
The concentrations in the reagent A solution are: S.I. Units
Phosphate buffer pH 6.8 20 mM (mg/dL) x 0.1665 = mmol/L
Sodium salicylate 61 mM REFERENCES VALUES
Sodium nitroprusiate 3.4 mM Serum, plasma: 6 - 20 mg/dL urea
EDTA-Na2 1.34 mM >60 years: 8 - 23 mg/dL urea
Urease ≥ 23 U/mL Urine: 10 - 20 g/24h urea.
Stabilizers
Serum concentartions tend to be slightly higher in males than in females. The stated values
Concentrations of reagent B solution are: are for guidance. It is advisable that each laboratory determines its own reference values.
Alkaline hypochlorite 7.5 mM
NaOH 160 mM Results as BUN (Blood Urea Nitrogen)
mg/dL urea x 0.467 = mg/dL BUN
Standard: Aqueous solution of urea equivalent to 40 mg/dL (6.6 mmol/L)
PERFORMANCE CHARACTERISTICS
STORAGE AND STABILITY Performance of the reagent depends on the reagent itself and also depends on method
The components of the kit, stored at 2-8ºC, will remain stable until the expiration date stated and analyzer used.
on the label. Once the urease/salicylate vial has been dissolved, will remain stable for 4 The results indicated are obtained using a manual method.
weeks, if stored protected from light at 2-8ºC. The alkaline hypochlorite solution will remain
stable for 8 months, if stored in the same way. Sensitivity, as detection limit: 2.0 mg/dL
Linearity: Up to 400 mg/dL of Urea. For higher values, dilute the sample 1/2 in deionised
Signs of reagent deterioration: water and assay once again. Multiply the final result by 2.
Presence of particles or turbidity in the reagent. Working reagent blank >0.500 Accuracy: 97.9 %.
Repetitivity as Variation Coefficient: 1.66%
ADDITIONAL EQUIPMENT Reproducibility, as Variation Coefficient: 2.05%
General laboratory equipment. Trueness: Results obtained with this reagent did not show systematic differences when
Spectrophotometer or photometer thermostatable at 37ºC. Cuvette: 1cm light-path compared with reference reagent.
SAMPLE
Details of the performance studies are available on request
Serum, plasma and urine. Urea will remain stable in serum for at least 1 day at room
temperature (≤ 25ºC), 5 days at 2-8ºC and 6 months when frozen (-20º C). In urine, urea will INTERFERENCES
remain stable, when kept at 2-8ºC, for 5 days, provided that the pH value be lower than 4. Any glassware contamination by ammonium salts or ammonia should be avoided.
If a urine sample is to be assayed, it should be previously diluted 1/100 with deionised Serum samples should be free from haemolysis and turbidity. Fluoride as well as ammonium
water. Multiply the final result by 100. heparinate inhibit the reaction.
CAUTION The use of disposable equipment is recommended to prevent unwanted contamination.
Reagent B: In case of contact with the skin, mucose or eyes, wash thoroughly with water REFERENCES
and ask the physician. Foster, L.B., Hochholzer, J.M. (1971), Clin. Chem., 17, 921-925.
The reagent A contains sodium azide at 0.09%. Handle with care. Wilcox, A., Wallace, E.C., Sterling, R.E., David, H.A., Ware, A.G. (1966), Clin. Chem. 12,
The safety statements are on the label. It is advisable to look at the MSDS before using 151-157.
the reagent. Sampson E.J., Baird M.A.,Burtis C.A., Smith E.M., Witte D.L.,Bayse D.D. (1980), Clin.
The disposal of the residues has to be made according to legal local regulations. Chem. 26,816-826.
B
8, PG III UN: 1760
H314,H400
P260,P264,P280,P303+P361+P353,P305+P351+P338,P310,P321
ES - UREA ENZIMÁTICA, HIPOCLIRITO ALCALINO
Peligro
Peligro: Provoca quemaduras graves en la piel y lesiones oculares graves. Muy tóxico para los
organismos acuáticos.
Precaución: No respirar el polvo/el humo/el gas/la niebla/los vapores/el aerosol. Lavarse
concienzudamente tras la manipulación. Llevar guantes/prendas/gafas/máscara de protección.
EN CASO DE CONTACTO CON LA PIEL (o el pelo): Quitar inmediatamente todas las prendas
contaminadas. Aclararse la piel con agua/ducharse. EN CASO DE CONTACTO CON LOS
OJOS: Aclarar cuidadosamente con agua durante varios minutos. Quitar las lentes de contacto,
si lleva y resulta fácil. Seguir aclarando. Llamar inmediatamente a un CENTRO DE TOXICOLO-
GlA/médico. Se necesita un tratamiento específico.
Contiene: hidróxido de sodio
GB - UREA ENZYMATIC, ALKALINE HYPOCHLORITE
Danger
Hazard: Causes severe skin burns and eye damage. Very toxic to aquatic life.
Precautionary: Do not breathe dust/fume/gas/mist/vapours/spray. Wash thoroughly after han-
dling. Wear protective gloves/protective clothing/eye protection/face protection. IF ON SKIN (or
hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. IF IN EYES:
Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to
do. Continue rinsing. Immediately call a POISON CENTER/doctor. Specific treatment.
Contains: caustic soda,sodium hydroxide
PT - URÉIA ENZIMÁTICA, HIPOCLORITO ALCALINO
Perigo
Perigo: Provoca queimaduras na pele e lesões oculares graves. Muito tóxico para os organis-
mos aquáticos.
Precaução: Não respirar as poeiras/fumos/gases/névoas/vapores/aerossóis. Lavar cuidadosa-
mente após manuseamento. Usar luvas de protecção/vestuário de protecção/protecção ocular/
protecção facial. SE ENTRAR EM CONTACTO COM A PELE (ou o cabelo): retirar imediata-
mente toda a roupa contaminada. Enxaguar a pele com água/tomar um duche. SE ENTRAR
EM CONTACTO COM OS OLHOS: enxaguar cuidadosamente com água durante vários
minutos. Se usar lentes de contacto, retire-as, se tal lhe for possível. Continuar a enxaguar.
Contacte imediatamente um CENTRO DE INFORMAÇÃO ANTIVENENOS/médico. Tratamento
específico.