E-Mail: sales@accubiotech.com

Products

ToRCH Test
ToRCH IgM Combo Serum Cassette

Catalog No.          Product Name               

ABT-IDT-B213           ToRCH IgM Combo Serum Cassette


INTENDED USE

ACCU-TELL®Rapid ToRCH IgM Combo Test Cassette(Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to Toxoplasma gondii (Toxo), Rubella virus (Rubella), Cytomegalovirus (CMV), and Herpes simplex virus 1/2 (HSV 1/2) in serum or plasma to aid in the diagnosis of ToRCH.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL®Rapid ToRCH IgM Combo Test Cassette (Serum/Plasma) was compared with leading commercial EIA Toxo, Rubella, CMV and HSV 1/2 tests; the results show that ACCU-TELL®Rapid ToRCH IgM Combo Test Cassette (Serum/Plasma) has a high sensitivity and specificity for each of its sections.


TOXO

Method

Toxo EIA (IgM)

Total Results

ACCUTELL® Rapid Toxo IgM Test Cassette

Results

Positive

Negative

Positive

71

7

78

Negative

2

674

676

Total Results

73

681

754

Relative Sensitivity: 97.3% (95%CI*: 90.5%~99.7%)

Relatively Specificity: 99.0% (95%CI*: 97.9%~99.6%)

Accuracy: 98.8 %( 95%CI*: 97.7%~99.5%)

*Confidence Intervals

 

Rubella

Method

CMV EIA (IgM)

Total Results

ACCU-TELL® Rapid Rubella IgM Test Cassette

Results

Positive

Negative

Positive

35

2

37

Negative

1

356

357

Total Results

36

358

394

Relative Sensitivity: 97.2% (95%CI*: 86.5%~100%)

Relatively Specificity: 99.4% (95%CI*: 97.8%~99.9%)

Accuracy: 99.2 %( 95%CI*: 97.6%~99.8%)

*Confidence Intervals

 

HSV 1/2

Method

HSV 1/2 EIA (IgM)

Total Results

ACCU-TELL® Rapid HSV 1/2 IgM Test Cassette

Results

Positive

Negative

Positive

28

1

29

Negative

2

348

350

Total Results

30

349

379

Relative Sensitivity: 93.3% (95%CI*: 77.9%~99.2%)

Relatively Specificity: 99.7% (95%CI*: 98.4%~100.0%)

Accuracy: 99.2 %( 95%CI*: 97.7%~99.8%)

*Confidence Intervals

 Precision

 Intra-Assay

Within-run precision has been determined by using 10 replicates of three specimens containing negative, low positive and high positive of Toxo, Rubella, CMV and HSV 1/2. The negative, low positive, and high positive values were correctly identified >99% of the time.

 Inter-Assay

Between-run precision has been determined by using the same three specimens of negative, low positive and high positive of Toxo, Rubella, CMV and HSV 1/2 in 3 independent assays. Three different lots of ACCU-TELL® Rapid ToRCH IgM Antibodies Combo Test Cassette (Serum/Plasma) have been tested using negative, low positive and high positive specimens. The specimens were correctly identified >99% of the time.

 Cross-reactivity

ACCU-TELL®Rapid ToRCH IgM Combo Test Cassette(Serum/Plasma) has been tested for HAV, HBV, HCV, HIV, RF, Syphilis, H. Pylori, Rubella, TOXO, HSV 1/2 positive specimens. The results showed no cross-reactivity.

 Interfering Substances

The following compounds have also been tested using ACCU-TELL®Rapid ToRCH IgM Combo Test Cassette(Serum/Plasma) and no interference was observed.

Acetaminophen

Caffeine:

EDTA

Acetylsalicylic Acid

Gentisic Acid

Ethanol

Ascorbic Acid

Phenylpropanolamine

Glucose

Bilirubin: 1g/dL

Salicylic Acid

Phenothiazine

 

LIMITATIONS

  1. ACCU-TELL®Rapid ToRCH IgM Combo Test Cassette(Serum/Plasma) is for in vitro diagnostic use only. This test should be used for detection of IgM antibodies to Toxo, Rubella, CMV and HSV 1/2 in serum or plasma specimens. Neither the quantitative value nor the rate of increase in the concentration of IgM antibodies to Toxo, Rubella, CMV and HSV 1/2 can be determined by this qualitative test.

  2. ACCU-TELL®Rapid ToRCH IgM Combo Test Cassette(Serum/Plasma) will only indicate the presence of IgM antibodies to Toxo, Rubella, CMV and HSV 1/2 in the specimen and should not be used as the sole criteria for the diagnosis of ToRCH infections for which the positive result is obtained.

  3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

  4. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result for any one out of the four infections of ToRCH at any time does not preclude the possibility of that particular infection.