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Toxo IgG/IgM Serum Cassette

Catalog No.        Product Name                 

ABT-FT-B209         Toxo IgG/IgM Serum/Plasma Cassette

 

INTENDED USE

ACCU-TELL®Rapid Toxo IgG/IgM Test Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM anti-Toxoplasma Gondii (T. gondii) and IgG anti- T. gondii in human serum or plasma. This kit is intended to be used as a screening test and as an aid in the diagnosis of infection with T. gondii. Any reactive specimen with the Toxo IgG/IgM Rapid Test Cassette must be confirmed with alternative testing method(s) and clinical findings.

PERFORMANCE CHARACTERISTICS

 Sensitivity and Specificity

A clinical evaluation was conducted comparing the results obtained using ACCU-TELL®Rapid Toxo IgG/IgM Test Cassette (Serum/Plasma) to Toxo IgG/IgM ELISA Testing. The study included 368 IgG specimens and 230 IgM specimens, and about the IgG specimen both assays identified 297 negative and 63 positive results, about the IgM specimen both assays identified 199 negative and 30 positive results.

 IgG Results

 

Method

 

 

T.Gondii EIA (IgG)

Total Results

 

 

ACCU-TELL® Rapid Toxo IgG/IgM

Test

Cassette for IgG

Results

Positive

Negative

 

 

 

 

Positive

63

3

66

 

 

Negative

5

297

302

 

 

Total Results

 

68

300

368

 

Relative Sensitivity:92.6% (95%CI*: 83.7%~97.6%);

Relative Specificity:99.0% (95%CI*: 97.1%~99.8%);

Accuracy:97.8% (95%CI*: 95.8%~99.1%).

*Confidence Intervals

 IgM Results

 

Method

 

 

T.Gondii EIA (IgG)

Total Results

 

 

ACCU-TELL® Rapid Toxo IgG/IgM

Test

Cassette for IgM

Results

Positive

Negative

 

 

 

 

Positive

30

1

31

 

 

Negative

0

199

199

 

 

Total Results

 

30

200

230

 

Relative Sensitivity: 99.9% (95%CI*: 90.5%-100%);

Relative Specificity: 99.5% (95%CI*: 97.2%-100%);

Accuracy: 99.6% (95%CI*: 97.6%-100%).

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 10 replicates of three specimens: a negative, a low positive, and a high positive. The negative, low 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 three specimens: a negative, a low positive, and a high positive. Three different lots of ACCU-TELL®Rapid Toxo IgG/IgM Test Cassette (Serum/Plasma)have been tested over a 3-day period using negative, low positive, and high positive specimens. The specimens were correctly identified >99% of the time.

 Cross-reactivity

ACCU-TELL®Rapid Toxo IgG/IgM Test Cassette (Serum/Plasma) has been tested for HBsAg, HBsAb, HbeAg, HBeAb, HBcAb, HCV,HIV, Syphilis, H. Pylori, CMV and Rubella positive specimens. The results showed no cross-reactivity.

 Interfering Substances

The following potentially interfering substances were added to TOXO 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

Bilirubin: 1g/dL

Oxalic Acid: 600mg/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 T.gondii in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.

  2. ACCU-TELL®Rapid Toxo IgG/IgM Test Cassette (Serum/Plasma)is limited to the qualitative detection of the antibodies to T.gondii in human serum or plasma. The intensity of the test band does not linear correlation with the antibody titer in the specimen.
  3. A negative result for an individual subject indicates absence of detectable T. gondii antibodies. However, a negative test result does not preclude the possibility of exposure to or infection with T. gondii
  4. A negative result can occur if the quantity of the T. gondii 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.