Accu-Tell^® HEV IgM Rapid Test Cassette (Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: IgM antibody to Hepatitis E virus (HEV) in serum or plasma.

Reading time: 10 minutes

Relative Sensitivity: 97.4%

Relative Specificity: 99.1%

Accuracy: 98.9%

INTRODUCTION

Hepatitis E is a recurring infection in developing countries. In less frequent, isolated cases, it has also been reported in developed countries. Identified in 1990, Hepatitis E (HEV) is a non-enveloped, single-stranded RNA virus where infection can lead to acute (or subclinical) liver disease, like that associated to hepatitis A infection. Fatality rates are generally low - averaging 0.5-3 percent for most patients, while pregnant women hold elevated averages around 15-25 percent.

INTENDED USE

ACCU-TELL^® HEV IgM Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatitis E virus (HEV) in serum or plasma.

TEST PROCEDURE

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1.   Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening foil pouch.

2.   Place the cassette on a clean and level surface.

For Serum/Plasma specimen:

·  Use a disposal specimen dropper: Hold the dropper vertically, draw the specimen up to the Fill Line as shown in illustration below (approximately 5ul). Transfer the specimen to the specimen well(S), then add 1 drop of buffer (approximately 40ul) into the dilution well (B), and start the timer.

·  Use a pipette: To transfer 5ul of Serum/Plasma specimen to the specimen well(S), then add 1 drop of buffer (approximately 40ul) into the dilution well (B), and start the timer.

3.      Wait for the colored line(s) to appear. The test result should be read at 10 minutes.

Do not interpret the result after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL^® HEV IgM Cassette (Serum/Plasma) was compared with a leading commercial ELISA HEV IgM test; the results show that ACCU-TELL® HEV IgM Cassette (Serum/Plasma) has a high sensitivity and specificity.

Relative sensitivity: 97.4% (95%CI*: 86.5%~99.9%);  

Relative specificity: 99.1% (95%CI*: 96.9%~99.9%);

Accuracy: 98.9% (95%CI*: 96.7%~99.8%).      

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 10 replicates of four specimens: a negative, a low positive, a medium positive and a high positive. The negative, low positive, medium positive and high positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 3 independent assays on the same four specimens: a negative, a low positive, a medium positive and a high positive. Three different lots of ACCU-TELL® HEV IgM Cassette (Serum/Plasma) have been tested over a 10-day period using negative, low positive, medium positive and high positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

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

Interfering Substances

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

Acetaminophen:  20 mg/dL                                

Caffeine: 20 mg/dL

Acetylsalicylic Acid:  20 mg/dL                           

Gentisic Acid: 20 mg/dL

Ascorbic Acid:  2g/dL                                         

Albumin: 2 g/dL

Creatin: 200 mg/dL                                             

Hemoglobin: 1.1 mg/dL

Bilirubin: 1g/dL                                                   

Oxalic Acid: 600mg/dL

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

LIMITATIONS

1. ACCU-TELL^® HEV IgM Cassette (Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of anti-HEV IgM in serum or plasma specimens only and should not be used as the sole criteria for the diagnosis of HEV infection. Neither the quantitative value nor the rate of increase in anti-HEV IgM can be determined by this qualitative test.

2. The Assay Procedure and the Assay Result Interpretation must be followed closely when testing the presence of anti-HEV IgM in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.

3. ACCU-TELL^® HEV IgM Cassette (Serum/Plasma)  is limited to the qualitative detection of anti-HEV IgM in human 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-HEV IgM. However, a negative test result does not preclude the possibility of exposure to or infection with HEV.

5. A negative result can occur if the quantity of the anti-HEV 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. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

8. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of HEV infection.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.