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Products

HAV Test
HAV IgG/IgM Test Cassette

Catalog No.       Product Name

ABT-IDT-B226        HAV IgG/IgM Serum Test Cassette

 

INTENDED USE

ACCU-TELL® Rapid HAV IgG/IgM Test Cassette(Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Hepatitis A virus in human serum or plasma.


 

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Rapid HAV IgG/IgM Test Cassette(Serum/Plasma) was compared with a leading commercial HAV ELISA test.

The results show that the overall relative sensitivity for the primary and secondary infection of ACCU-TELL® Rapid HAV IgG/IgM Test Cassette(Serum/Plasma) is 95.6%, and the relative specificity is >99.9%,and the relative accuracy is 99.1%.

HAV Primary Infection for IgG/IgM test results

Method

ELISA

ACCU-TELL® Rapid HAV IgG/IgM Test Cassette

(Serum/Plasma)

Results

Positive

Negative

IgM

IgG

Positive

IgM

25

0

0

IgG

3

0

0

Negative

0

0

0

Relative Sensitivity

89.3%

/

/

HAV Secondary Infection for I IgG/IgM test results

Method

ELISA

ACCU-TELL® Rapid HAV IgG/IgM Test Cassette

(Serum/Plasma)

Results

Positive

Negative

IgM

IgG

Positive

IgM

36

0

0

IgG

4

40

0

Negative

0

0

0

Relative Sensitivity

90.0%

>99.9%

/

Non-HAV Infection for I IgG/IgM test results

Method

ELISA

ACCU-TELL® Rapid HAV IgG/IgM Test Cassette

(Serum/Plasma)

Results

Positive

Negative

IgM

IgG

Positive

IgM

0

0

0

IgG

0

0

0

Negative

0

0

248

Relative Sensitivity

/

/

>99.9%

Relative Sensitivity: (25+40)/ (28+40) =95.6% (95%CI*: 87.6%~99.1%);

Relative Specificity:248/248>99.9% (95%CI*: 98.8%~100.0%);

Accuracy: (25+40+248)/ (28+40+248) =99.1% (95%CI*: 97.2%~99.8%).

*95% Confidence Intervals

 Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. The specimens were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 15 independent assays on the same four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. Three different lots of ACCU-TELL® Rapid HAV IgG/IgM Test Cassette(Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL® Rapid HAV IgG/IgM Test Cassette(Serum/Plasma) has been tested by HAMA,RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, HCV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to HAV negative and positive specimens.

Acetaminophen: 20 mg/ Dl                Acetylsalicylic Acid: 20 mg/dL 

Ascorbic Acid:          2g/dL                 Bilirubin:                        1g/dL 

Creatin:            200 mg/dL                 Caffeine:                  20 mg/dL

Gentisic Acid:     20 mg/dL                 Albumin:                       2 g/dL 

Hemoglobin:    1000mg/dL                 Oxalic Acid:              60mg/dL

None of the substances at the concentration tested interfered in the assay.


LIMITATIONS

  1. ACCU-TELL® Rapid HAV IgG/IgM Test Cassette(Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of HAV IgG/IgM antibodies in serum or plasma specimens only. Neither the quantitative value nor the rate of increase in HAV antibody concentration can be determined by this qualitative test.

  2. ACCU-TELL® Rapid HAV IgG/IgM Test Cassette(Serum/Plasma) will only indicate the presence of HAV antibodies in the specimen and should not be used as the sole criteria for the diagnosis of HAV.

  3. ACCU-TELL® Rapid HAV IgG/IgM Test Cassette(Serum/Plasma) is limited to the qualitative detection of anti-HAV IgM inhuman serum or plasma. The intensity of the test band does not have linear correlation with the antibody titer in the specimen.

  4. A negative result for an individual subject indicates absence of detectable anti-HAV IgG and anti-HAV IgM. However, a negative test result does not preclude the possibility of exposure to or infection with HAV.

  5. A negative result can occur if the quantity of the anti-HAV IgG and anti-HAV IgM present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.

  6. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.

  7. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.