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

Product Description

CATALOG

KEY POINTS

Detection for: IgM anti-Toxo plasma Gondii(T. gondii) and IgG anti-T. gondii in human serum or plasma

Reading time: 15 minutes.

Sensitivity & Specificity & Accuracy:

Toxo IgG:

Sensitivity: 90.0%

Specificity: 99.1%

Accuracy: 98.0 %

Toxo IgM:

Sensitivity: ＞99.9%

Specificity: 99.5%

Accuracy:99.6%

INTRODUCTION

T. gondii is an obligate intracellular protozoan parasite with a worldwide distribution. Serological data indicates that approximately 30% of the population of most industrialized nations is chronically infected with the organism.

INTENDED USE

ACCU-TELL^® TOXO IgG/IgM Rapid Test Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM anti-Toxo plasma 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 ACCU-TELL^® TOXO IgG/IgM Cassette (Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.

TEST PROCEDURE

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 within one hour.

2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 3 drops of serum or plasma (Approx.75 μl) to the specimen well of the test cassette. Avoid trapping air bubbles in the specimen well. See the illustration above.

3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 15minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

A clinical evaluation was conducted comparing the results obtained using ACCU-TELL^® TOXO IgG/IgM Cassette (Serum/Plasma) to TOXO IgG/IgM ELISA Testing. The study included 252 IgG specimens and 223 IgMspecimen, and about the IgG specimen both assays identified 220 negative and 27 positive results, about the IgM specimen both assays identified 197 negative and 25 positive results.

IgG Results

Sensitivity: 90.0% (95%CI:   73.4%~97.9%)*

Specificity:   99.1% (95%CI: 96.8%~99.9%)*

Accuracy: 98.0 %( 95%CI: 95.4%~99.4%)*

*Confidence Interval

IgM Results

Sensitivity: ＞99.9%(95%CI:88.7%-100%)*

Specificity: 99.5% (95%CI:97.2%~100%)*

Accuracy:99.6%(95%CI:97.5%~100%)*

*Confidence interval

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^® TOXO IgG/IgM Cassette ACCU-TELL^® TOXO IgG/IgM 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^® TOXO IgG/IgM 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

AcetylsalicylicAcid:          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^® TOXO IgG/IgM 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.

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