15 Tests/ 30 Tests

IgM 52009029/ 52009046

PERFORMANCE CHARACTERISTICS
INTENDED USE:
MEASURING RANGE
This reagent is intended for the invitro quantitative determination of IgM in human
serum by nephelometric immunoassay 15– 400mg/dL
-Nephelometry methodology DETECTION LIMIT
-Linear up to 400mg/dL 15mg/dL
-Ready to use reagents PRECISION:[%CV]
-No calibration required
INTRA RUN
-Lower detection level 15mg/dL
Level1 Level 3
CLINICAL SIGNIFICANCE Mean(mg/dL) 75.35 231.55
IgM is important in early response to infections. The measurement of IgM is important for SD 1.15 6.27
typing immunodeficiencies and myelomas. Furthermore it plays a role in acute and chronic
infections as first line of defense of the body. Serum levels may be increased in all kinds of CV(%) 1.53 2.71
acute infections. Elevated levels in chord serum suggest clinical infection in new born. n 20 20
PRINCIPLE
Antibodies to IgM in the reagent are combined with IgM in the patient’s serum, forming INTER RUN
immune complexes. The immune complexes cause an increase in light scattering which Level1 Level 3
correlate with the concentration of IgM in the serum. Mean(mg/dL) 75.25 239.32
SD 1.87 4.09
REAGENT COMPOSITION
CV(%) 2.49 1.71
IgM R1 : 1x 1.7mL / 1x 2.6 mL n 20 20
Tris(hydroxymethyl)aminomethane buffer
IgM R2 : 1x 3.6mL / 1x 6.5 mL Accuracy in mg/dL
Anti-human IgM antiserum Immunology control Assigned value Measured value
Biorad Level 1 72.6(61.0-91.5) 75.35
STORAGE AND STABILITY
Biorad Level 3 231(185-277) 231.55
The sealed reagents are stable up to expiry date stated on the label when stored at
Agappe IC 157 (128-186) 153.38
2-8°C.
LINEARITY INTERFERENCES
The reagent is linear up to 400mg/dL. If the concentration is greater than linearity, Bilirubin up to 20 mg/dL and hemoglobin up to 1000 mg/dL do not interfere.
dilute the sample with normal saline and repeat the assay. Multiply the result with
dilution factor.
REFERENCES
REFERENCE RANGE
1. Otani, H., Medical Technology, 14, 965 (1986)
These reference values are given for orientation only. Each laboratory should establish
its own reference values.
mg/dL
< 1 yr: 0 – 145
1 – 3 Yrs: 19 – 146
4 – 12 yrs: 24 –179
> 13 Yrs: 35 – 220
SAMPLE
Fresh serum. Do not use lipemic or hemolysed sample.
PREPARATION AND STABILITY OF WORKING REAGENT
Reagent 1 and Reagent 2 are ready to use
Note: Once opened the reagents are stable for 60 days only.
PRECAUTIONS
To avoid contamination use clean dry pipette tips and cuvettes. Close reagent bottle
immediately after use. Avoid direct exposure of reagent to light.
PROCEDURE
The test procedure and the calibration data is provided in the smart card along with
the kit. Insert the smart card and follow the instructions
Step 1: Insert card to card reader slot and display will prompt to add R1+ Sample
Step 2: Pipette 60μL R1 and 10μL sample to cuvette and place the cuvette in to the
cuvette holder.
Step 3: After incubation display will prompt to add R2
.Step 4: Pipette 190μL R2 using attached sensor pipette to the cuvette.
Step 5: The result will show in the display and print out.

The calibration data is incorporated in the smart card and hence no calibration is required.

ADS/V.01/190314