1 x 45/1 x 5/1 mL

MICROALBUMIN TURBILATEX WITH CALIBRATOR 11805001

Intended Use Waste Management

This reagent is intended for in vitro quantitative determination of microal bumin Reagents must be disposed off in accordance with local regulations
in urine.
Sample
- Turbilatex method with high sensitivity & specificity Fresh urine.
- Linear up to 150 mg/L
Interferences
- Single point calibration No interference for
Clinical Significance Hemoglobin up to 1000 mg/dL
The significant increase of al bumin concentration in the urine has been used some Creatinine up to 3 g/L
years as an indicative value of incipient nephropathy and cardiovascular disease Bilirubin up to 10 mg/dL
in diabetic patients. Microal buminuria has also been associated with hypertension
and risk of cardiovascular disease in non-diabetic patients. Microal buminuria Materials Provided
occurs in response to acute inflammatory conditions such as ischemia, trauma Microal bumin Reagent R1,R2 & Calibrator
and thermal injury, surgery, pancreatitis and inflammatory bowel disease. In many
of these conditions, al bumin excretion increase within minutes or hours of the Materials Required but not Provided
initiating stimulus. The degree of microal buminuria is proportional to the severity l Pipettes & Tips
of the inflammatory process.
l Test Tubes & racks
Principle l Timer
Latex particles coated with anti-human al bumin are agglutinated when mixed with l Incubator
sample containing al bumin. The agglutination causes an absorbance change, l Analyzer
dependent upon al bumin concentration of the patient sample that can be
quantified by comparison with a calibrator of known micro al bumin concentration Test Parameters
Kit Components Ful ly Auto Semi Auto
Analyzer Analyzer
Reagent/ Product code Description
Component 11805001 Mode of reaction Rate Fixed time
Diluent
Microal bumin R1 1 x 45 mL Glycine buffer (pH 10.0) 100 mmol/L Slope of reaction Increasing Increasing
Sodium azide Wavelength 546 nm 546 nm
Microal bumin R2 1 x 5 mL Latex O O
Suspension of latex particles Temperature 37 C 37 C
coated with anti human
Al bumin (pH8.2) Calibrator concentration As mentioned on the As mentioned on the
Sodium azide 0.95 g/L vial label vial label
Microal bumin 1 x 1 mL Micro al bumin calibrator Linearity 150 mg/L 150 mg/L
Calibrator concentration as mentioned
on vial label Blank Reagent Blank DI Water

Risk & Safety Delay - 2 sec

Material safety data sheets (MSDS) will be provided on request Interval - 120 sec
Reagent Preparation Sample volume 3 µL 7 µL
Microal bumin Reagent1, Reagent 2 and calibrator are ready to use. Reagent 1 volume 270 µL 900 µL
Reagent Storage and Stability Reagent 2 volume 30 µL 100 µL
The sealed reagents are stable up to the expiry date stated on the label, when
0
stored at 2 - 8 C, protected from light. Do not freeze Cuvette 1 cm light path 1 cm light path

Open Vial Stability

o Application parameters for various instrument are available. Please contact
Once opened, the reagent is stable up to four weeks at 2-8 C if contamination is customer support department for specific information
avoided.
Calibration
Onboard Calibration Stability
Calibration is stable for 20 days Agappe Microal bumin Turbilatex calibrator is recommended for calibration of this
assay.
Reagent Deterioration
Turbidity or precipitation in any kit component indicates deterioration and the
Procedure Notes
component must be discarded. Values outside the recommended acceptable range
for the control may also be an indication of reagent instability and associated Laboratory Procedure for Ful ly Auto Analyzer
results are invalid. Sample should be retested using a fresh vial of reagent. Blank Calibrator Sample/control
Precaution M Al b R1 270 µL 270 µL 270 µL
To avoid contamination, use clean laboratory wares. Use clean, dry disposable Calibrator - 3 µL -
pipette tips for dispensing. Close reagent bottles immediately after use. Sample /control - - 3 µL
O
Avoid direct exposure of reagent to light. Do not blow into the reagent bottles. Mix and incubate for 5 minutes at 37 C.

This reagent is only for IVD use and follow the normal precaution required for M Al b R2 30 µL 30 µL 30 µL
handling all laboratory reagents Mix and read the absorbance immediately (A1), and after 2 minutes (A2) at
546 nm.

SYMBOLS USED ON THE LABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS LTD.

Agappe Hills, Dist. Ernakulam, Kerala, India-683 562.
Customer Care No. +91 484 3120002 ISO 9001:2008
customercare@agappe.in | www.agappe.com REV. NO.: ADL/IFU/MALB/TURBI/R00 EN ISO 13485:2012
 1 x 45/1 x 5/1 mL
MICROALBUMIN TURBILATEX WITH CALIBRATOR 11805001

Laboratory Procedure for Semi Auto Analyzer 3. Precision

Calibrator Sample/control Intra Run

M Al b R1 900 µL 900 µL Control Level 1 Control Level 2
Calibrator 7 µL - n 20 20
Sample/control - 7 µL Mean (mg/L) 28.19 88.98
M Al b R2 100 µL 100 µL SD 1.21 2.33
Mix and read the absorbance immediately (A1), and after 2 minutes (A2) at
CV(%) 4.3 2.62
546 nm.

Calculation Inter Run

(A2 - A1) sample Control Level 1 Control Level 2
Micro Al bumin Conc. in mg/L = ———————————— x Calibrator Conc.
(A2 - A1) calibrator n 20 20
Quality Control Mean (mg/L) 28.08 88.81
It is recommended to use control to verify the performance of the assay. Each SD 1.06 1.86
laboratory has to establish its own internal quality control scheme and procedure
CV(%) 3.78 2.1
for corrective action, if control do not recover within the acceptable range.
Reference Range
Accuracy (mg/L)
It is recommended that each laboratory establish its own reference values.
Control Expected Value Measured Value
The following value may be used as guide line.
Urine : up to 15 mg/L Control Level 1 22.1 ± 9.1 26
Results obtained for patient samples are to be correlated with clinical findings of Control Level 2 82.2 ± 26.9 91
patient for interpretation and diagnosis.
4.Sensitivity
Performance
Lower detection Limit is 2 mg/L
1. Linearity
This reagent is linear up to 150 mg/L Bibliography
If the concentration is greater than linearity (150 mg/L), dilute the sample 1. Feldt –Rasmussen, B. et al J Diab Comp 1994; 8; 137 145
with normal saline and repeat the assay. Multiply the result with dilution factor 2. Panuyiotou, B. N. Journal international Medical Research 1994 ; 22;181,
Prozone effect: No prozone effect was detected up to >1000 mg/L 181-201
3. Bar, J. et al Diabetic Medicine 1995; 12;649-656
2. Comparison
4. Gil bert , R. E. et al Diabetic Medicine 1994; 11;636 - 645
A comparison study has been performed between Agappe reagent and another
internationally available reagent yielded a correlation coefficient of r2 = 0.9889 5. Medcalf, E. A. et al. Clin chem. 1990; 36/3; 446-449
and a regression equation of y = 1.0174x 6. Young, D. S. Eeffects of drugs on clinical laboratory test, 4th ed. AACC Press,
1995.

SYMBOLS USED ON THE LABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS LTD.

Agappe Hills, Dist. Ernakulam, Kerala, India-683 562.
Customer Care No. +91 484 3120002 ISO 9001:2008
customercare@agappe.in | www.agappe.com REV. NO.: ADL/IFU/MALB/TURBI/R00 EN ISO 13485:2012