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Accu-Tell® ToRCH IgG/IgM Combo Rapid Test Cassette (Serum/Plasma)

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Accu-Tell® ToRCH IgG/IgM Combo Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG/IgM antibodies to Toxo plasma gondii (Toxo), Rubella virus (Rubella), Cytomegalovirus (CMV), and Herpes simplex virus 2 (HSV-2) in serum or plasma to aid in the diagnosis of ToRCH.
Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
ToRCH IgG/IGM Combo CassetteSerum/PlasmaABT-FT-B29830T/15T


KEY POINTS

Detection for: IgG/IgM antibodies to Toxo plasma gondii (Toxo), Rubella virus (Rubella), Cytomegalovirus (CMV), and Herpes simplex virus 2 (HSV-2) in serum or plasma;

Reading time: 15 minutes.

 

INTRODUCTION

ToRCH is an acronym for a group of infectious diseases that, while infecting the pregnant women, may cause birth defects in their newborns.1ToRCH stands for 4 different infections that can adversely affect the pregnant women and the fetus, newborn children including birth defects and often leading to abortion. The four pathogens are Toxo plasma gondii (parasitic protozoan), Rubella virus, CMV – Cytomegalovirus (Virus), HSV-2 – Herpes Simplex Virus 2 (Virus). The infections usually cause few, if any, symptoms in the pregnant woman, but pose greater risks of serious birth defects for neonates.

 

INTENDED USE

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

 

TEST PROCEDURE

ToRCH IgG IgM Rapid Test Procedure.png

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 1 drop of serum/plasma (approximately 25 μl) and 2 drops of buffer (approx. 80µl) to each specimen well of the test cassette respectively, and then start the timer. 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 20 minutes.


PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

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

TOXO IgM

MethodToxo EIA (IgM)Total Results
Toxo IgM Test CassetteResultsPositiveNegative
Positive25126
Negative2219221
Total Results27220247

Sensitivity: 92.6% (95%CI: 75.7%-99.1%)*

Specificity: 99.5% (95%CI: 97.5%~99.9%)*

Accuracy: 98.8% (95%CI: 96.5%~99.7%)*

*Confidence interval

TOXO IgG

MethodToxo EIA (IgG)Total Results
TOXO IgG Test CassetteResultsPositiveNegative
Positive30232
Negative3229232
Total Results33231264

Sensitivity: 90.9% (95%CI: 75.7%-98.1%)*

Specificity: 99.1% (95%CI: 96.9%~99.9%)*

Accuracy: 98.1% (95%CI: 95.6%~99.4%)*

*Confidence interval

Rubella IgM

MethodRubella EIA (IgM)Total Results
Rubella IgM Test CassetteResultsPositiveNegative
Positive22224
Negative1300301
Total Results23302325

Sensitivity: 95.7% (95%CI*: 78.1%~99.9%)

Specificity: 99.3% (95%CI*: 97.6%~99.9%)

Accuracy: 99.1 %( 95%CI*: 97.3%~99.8%)

*Confidence Interval

Rubella IgG

MethodRubella EIA (IgG)Total Results
Rubella IgG Test CassetteResultsPositiveNegative
Positive2411242
Negative22527
Total Results24326269

Sensitivity: 99.2% (95%CI*: 97.1%~99.9%)

Specificity: 96.2% (95%CI*: 80.4%~99.9%)

Accuracy:  98.9% (95%CI*: 96.8%~99.8%)

*Confidence Interval

CMV IgM

MethodCMV EIA (IgM)Total Results
CMV IgM Test CassetteResultsPositiveNegative
Positive31132
Negative2214216
Total Results33215248

Sensitivity: 93.9% (95%CI*: 79.8%~99.3%)

Specificity: 99.5% (95%CI*: 97.4%~99.9%)

Accuracy: 98.8 %( 95%CI*: 96.5%~99.7%)

*Confidence Interval

CMV IgG

MethodCMV EIA (IgG)Total Results
CMV IgG Test CassetteResultsPositiveNegative
Positive2101211
Negative23638
Total Results21237249

Sensitivity: 99.1% (95%CI*: 96.6%~99.9%)

Specificity: 97.3% (95%CI*: 85.8%~99.9%)

Accuracy: 98.8 % (95%CI*: 96.5%~99.8%)

*Confidence Interval

HSV-2 IgM

MethodHSV-2 EIA (IgM)Total Results
HSV -2 IgM Test CassetteResultsPositiveNegative
Positive18018
Negative2200202
Total Results20200220

Sensitivity: 90.0% (95%CI*: 68.3%~98.8%)

Specificity: 100% (95%CI*: 98.5%~100.0%)

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

*Confidence Interval

HSV-2 IgG

MethodHSV-2 EIA (IgG)Total Results
HSV-2 IgG Test CassetteResultsPositiveNegative
Positive30131
Negative3199202
Total Results33200233

Sensitivity: 90.9% (95%CI*: 75.7%~98.1%)

Specificity: 99.5% (95%CI*: 97.2%~99.9%)

Accuracy: 98.3 %( 95%CI*: 95.7%~99.5%)

*Confidence Interval

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of the specimens containing negative, low positive, middle and high positive of Toxo, Rubella, CMV and HSV-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 specimens of negative, low positive, middle and high positive of Toxo, Rubella, CMV and HSV -2 in 15 independent assays. Three different lots of ACCU-TELL® ToRCH IgG/IgM Combo Cassette (Serum/Plasma) have been tested using negative, low positive, middle and high positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL® ToRCH IgG/IgM Combo Cassette (Serum/Plasma) has been tested for HAV+, HBV+, HIV+, HCV+, HEV+, Syphilis+, HAMA+, RF+, H.pylori+, MONO+, CEA and AFP. The results showed no cross-reactivity. In addition, the rubella, CMV and HSV-2 IgG/IgM positive for Toxo section, the Toxo, CMV and HSV-2 IgG/IgM positive for Rubella section, the Toxo, Rubella and HSV-2IgG/IgM positive for CMV section and the Toxo, Rubella and CMV IgG/IgM positive for HSV-2 section showed no cross-reactivity.

Interfering Substances

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

Ascorbic Acid:  20mg/ml        

Hemoglobin: 1000mg/dl        

Gentisic Acid: 20 mg/dL

Oxalic Acid: 60mg/dL              

Bilirubin: 1000mg/dL             

Uric acid: 20mg/ml

Acetaminophen:  20 mg/dL     

Aspirin: 20mg/dl                    

Methanol:10%

Creatine: 200mg/dl                  

Albumin: 2g/dL                     

Caffeine: 20mg/dl

 

LIMITATIONS

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

2. ACCU-TELL® ToRCH IgG/IgM Combo Cassette (Serum/Plasma) will only indicate the presence of IgG/IgM antibodies to Toxo, Rub, CMV and HSV-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.

 

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