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Products

Leishmania Test
Leishmania Serum Cassette

Catalog No.          Product Name               

ABT-IDT-B223      Leishmania Serum Cassette


INTENDED USE

ACCU-TELL®Rapid Leishmania IgG/IgM Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Leishmania in human’s serum or plasma.

PERFORMANCE CHARACTERISTICS

 Sensitivity and Specificity

A total of 235 samples from susceptible subjects were tested by ACCU-TELL®Rapid Leishmania IgG/IgM Test Cassette (Serum/Plasma) and by a commercial L. donovani IgM EIA. Comparison for all subjects is shown in the following table.

IgM Results

Method

ELA

Total Results

ACCUTELL® Rapid Leishmania IgG/IgM Test Cassette

Results

Positive

Negative

Positive

31

2

34

Negative

3

199

201

Total Results

34

201

235

Relative Sensitivity: 91.2% (95%CI:*76.3%-98.1%)

Relative Specificity: 99.0% (95%CI:*96.5%-99.9%)

Accuracy: 97.9% (95%CI:*95.1%-99.3%)

*Confidence Intervals

A total of 214 samples from susceptible subjects were tested by ACCU-TELL®Rapid Leishmania IgG/IgM Test Cassette (Serum/Plasma) and by a commercial L. donovani IgM EIA. Comparison for all subjects is shown in the following table..

IgG Results

Method

ELA

Total Results

ACCU-TELL® Rapid Leishmania IgG/IgM Test Cassette

Results

Positive

Negative

Positive

13

2

15

Negative

1

198

199

Total Results

14

200

214

Relative Sensitivity: 92.9% (95%CI:*66.1%-99.8%)

Relative Specificity: 99.0% (95%CI:*96.4%-99.9%)

Accuracy: 98.6% (95%CI:*96.0%-99.7%)

*Confidence Intervals

 Precision

 Intra-Assay

Within-run precision has been determined by using 20 replicates of three specimens: a negative, a Leishmania IgM low titer positive, a Leishmania IgM high titer positive, a Leishmania IgG low titer positive and a Leishmania IgG high titer positive. The negative, a Leishmania IgM low titer positive, a Leishmania IgM high titer positive, a Leishmania IgG low titer positive and a Leishmania IgG high titer positive values were correctly identified 100% of the time.

 Inter-Assay

Between-run precision has been determined by 20 independent assays on the same three specimens: a negative, a Leishmania IgM low titer positive, a Leishmania IgM high titer positive, a Leishmania IgG low titer positive and a Leishmania IgG high titer positive. Three different lots of ACCU-TELL®Rapid Leishmania IgG/IgM Test Cassette (Serum/Plasma) have been tested over a 3-month period using negative, a Leishmania IgM low titer positive, a Leishmania IgM high titer positive, a Leishmania IgG low titer positive and a Leishmania IgG high titer positive specimens. The specimens were correctly identified 100% of the time.

 Cross-reactivity

ACCU-TELL®Rapid Leishmania IgG/IgM Test Cassette (Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, 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 HCV negative and positive specimens.

Acetaminophen: 20mg/dL               Caffeine: 20mg/dL

Acetylsalicylic Acid: 20mg/dL                Gentisic Acid: 20mg/dL

Ascorbic Acid: 2g/dL                     Albumin: 2g/dL

Creatin: 200mg/dL                        Hemoglobin 1000mg/dL

Bilirubin: 1g/dL                              Oxalic Acid: 60mg/dL

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

 


LIMITATIONS

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

  2. ACCU-TELL®Rapid Leishmania IgG/IgM Test Cassette (Serum/Plasma) is limited to the qualitative detection of antibodies to L. donovani in human serum or plasma. 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 anti-L. donovani antibodies. However, a negative test result does not preclude the possibility of exposure to Visceral leishmaniasis causative species of the L. donovani

  4. A negative result can occur if the quantity of the L. donovani 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. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical finding.