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Products

Filariasis Test
Filariasis IgG/IgM WB Cassette

Catalog No.          Product Name               

ABT-IDT-B221      Filariasis IgG/IgM WB Cassette


INTENDED USE

ACCU-TELL® Rapid Filariasis Test Cassette(Whole Blood/Serum /Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Filarial parasites (W. bancrofti and B. ma layi) in whole blood, serum, or plasma to aid in the diagnosis of Filariasis.

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

IgG Results

40 samples from patients with chronic lymphatic filariasis and 251 samples collected from a non-filariasis region were tested by ACCU-TELL® Rapid Filariasis Test Cassette(Whole Blood/Serum/ Plasma). Comparison for all subjects is showed in the following table

Method

ELISA

Total Results

ACCU-TELL®Rapid Filariasis Test Cassette

Results

Positive

Negative

Positive

37

4

41

Negative

3

247

250

Total Results

40

251

291

Relative Sensitivity: 92.5% (95%CI*: 79.6%-98.4%)             

*Confidence Interval

Relatively Specificity: 98.4% (95%CI*: 96.0%-99.6%)

Accuracy: 97.6% (95%CI*: 95.1%-99.0%)            

IgM Results

32 samples from patients with chronic lymphatic filariasis and 251 samples collected from a non-filariasis region were tested by ACCU-TELL® Rapid Filariasis Test Cassette(Whole Blood/Serum/ Plasma). Comparison for all subjects is showed in the following table

Method

ELISA

Total Results

ACCU-TELL®Rapid Filariasis Test Cassette

Results

Positive

Negative

Positive

31

3

34

Negative

1

248

249

Total Results

32

251

283

Relative Sensitivity: 96.9% (95%CI*: 83.8%-99.9%)             

*Confidence Interval

Relatively Specificity: 98.8% (95%CI*: 96.5%-99.8%)

Accuracy: 98.6% (95%CI*: 96.4%-99.6%)

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 10 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®Rapid Filariasis Test Cassette (Whole Blood/Serum/Plasma) have been tested using negative, low positive, medium positive and high positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

Sera containing known amounts of antibodies to Filariasis have been tested with Hepatitis A, B, C, E, HIV and Syphilis. No cross-reactivity was observed, indicating that ACCU-TELL® Rapid Filariasis Test Cassette(Whole Blood/Serum/Plasma) has a high degree of specificity for antibodies to H. pylori.

Interfering Substances

ACCU-TELL® Rapid Filariasis Test Cassette(Whole Blood/Serum/Plasma) has been tested for possible interference from visibly hemolyzed and lipemic specimens, as well as serum specimens containing high bilirubin levels. In addition, no interference was observed in specimens containing up to 1,000 mg/dL hemoglobin; up to 1,000 mg/dL bilirubin; and up to 2,000 mg/dL human serum albumin.

 

LIMITATIONS

  1. The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of antibodies to filarial parasites in serum, plasma or whole blood from individual subjects. Failure to follow the procedure may give inaccurate results.

  2. ACCU-TELL®Rapid Filariasis Test Cassette (Whole Blood/Serum/Plasma) is limited to the qualitative detection of antibodies to W. bancrofti and B. malayi in human serum, plasma or whole blood. The intensity of the test band does not have linear correlation with the antibody titer in the specimen.

  3. A negative result for an individual subject indicates absence of detectable W. bancrofti and B. malayi antibodies. However, a negative test result does not preclude the possibility of exposure to W. bancrofti and B. malayi.

  4. A negative result can occur if the concentration of W. bancrofti and B. malayi antibodies 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.

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

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