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

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

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Accu-Tell® ToRCH IgG Combo Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Toxoplasma 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

Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
ToRCH IgG Combo CassetteSerum/PlasmaABT-FT-B30815T


KEY POINTS

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

Reading time: 15 minutes

Sensitivity & Specificity & Accuracy:

TOXO:

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:

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:

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:

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

 

INTRODUCTION

ToRCH is an acronym for a group of infectious diseases that, while infecting the pregnant women, may cause birth defects in their newborns.1 ToRCH 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 infections are Toxomplasma gondii (A spirochete), 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 Combo Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Toxoplasma 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 Rapid Test Procedure.jpg

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 draw the serum/plasma up to the Fill Line as shown in illustration below (approximately 10 μl ) to the S area of each specimen well of the test cassette, then add 2 drops of buffer (approx. 80 μl) respectively and start the timer. Avoid trapping air bubbles in the specimen well. See the illustration below.

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 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 Combo Cassette (Serum/Plasma) has a high sensitivity and specificity for each of its sections.

TOXO

MethodT.Gondii ELISA (IgG)Total Results
TOXO IgG 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

MethodRubella EIA (IgG)Total Results
Rubella IgG 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

MethodCMV EIA (IgG)Total Results
CMV IgG 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

MethodHSV 1/2 EIA (IgG)Total Results
HSV-2 IgG 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 10 replicates of three specimens containing negative, low positive 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 same three specimens of negative, low positive and high positive of Toxo, Rubella, CMV and HSV-2 in 3 independent assays. Three different lots of ACCU-TELL® ToRCH IgG Combo 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® ToRCH IgG Combo Cassette (Serum/Plasma) has been tested for HAV, HBV, HCV, HIV, RF, Syphilis, H. Pylori. The results showed no cross-reactivity. In addition, the rubella, CMV and HSV-2 IgG positive for Toxo section, the Toxo, CMV and HSV-2 IgG positive for Rubella section, the Toxo, Rubella and HSV-2 IgG positive for CMV section and the Toxo, Rubella and CMV IgG positive for HSV-2 section showed no cross-reactivity.

Interfering Substances

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

Acetaminophen: 20mg/dl         

Caffeine: 20mg/dl                                    

Hemoglobin: 1g/dl          

Oxalic acid: 60mg/dl                         

Bilirubin: 1g/dL                              

Uric acid: 20mg/ml               

Ascorbic Acid: 20mg/ml                    

Aspirin: 20mg/dl                                           

Methanol: 10%               

Gentisic Acid: 20mg/dl                      

Creatine: 200mg/dl                                   

Albumin: 2g/dl

 

LIMITATIONS

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

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

 

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