Parsagen® ToRCH IgM Combo 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-2 (HSV-2) in serum or plasma to aid in the diagnosis of ToRCH.
Product Description
CATALOG
| Product Name | Specimen | Catalog No. | Quantity per box |
| ToRCH IGM Combo Cassette | Serum/Plasma | PS-C-0031 | 15T |
KEY POINTS
Detection for: IgM 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: 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%)
Rubella:
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%)
CMV:
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%)
HSV-2:
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
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
Parsagen® ToRCH IgM Combo 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-2 (HSV-2) in serum or plasma to aid in the diagnosis of ToRCH.
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 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
Parsagen® ToRCH IgM Combo Cassette (Serum/Plasma) was compared with leading commercial EIA Toxo, Rubella, CMV and HSV-2 tests; the results show that Parsagen® ToRCH IgM Combo Cassette (Serum/Plasma) has a high sensitivity and specificity for each of its sections.
TOXO
| Method | Toxo EIA (IgM) | Total Results | ||
| Toxo IgM Test Cassette(Serum/Plasma) | Results | Positive | Negative | |
| Positive | 25 | 1 | 26 | |
| Negative | 2 | 219 | 221 | |
| Total Results | 27 | 220 | 247 | |
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
Rubella
| Method | Rubella EIA (IgM) | Total Results | ||
| Rubella IgM Test Cassette(Serum/Plasma) | Results | Positive | Negative | |
| Positive | 22 | 2 | 24 | |
| Negative | 1 | 300 | 301 | |
| Total Results | 23 | 302 | 325 | |
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
CMV
| Method | CMV EIA (IgM) | Total Results | ||
| CMV IgM Test Cassette(Serum/Plasma) | Results | Positive | Negative | |
| Positive | 31 | 1 | 32 | |
| Negative | 2 | 214 | 216 | |
| Total Results | 33 | 215 | 248 | |
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
HSV-2
| Method | HSV 1/2 EIA (IgM) | Total Results | ||
| HSV-2 IgM Test Cassette(Serum/Plasma) | Results | Positive | Negative | |
| Positive | 18 | 0 | 18 | |
| Negative | 2 | 200 | 202 | |
| Total Results | 20 | 200 | 220 | |
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
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 the ToRCH IgM Antibodies Combo Rapid Test 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
Parsagen® ToRCH 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 IgM positive for Toxo section, the Toxo, CMV and HSV-2 IgM positive for Rubella section, the Toxo, Rubella and HSV-2 IgM positive for CMV section and the Toxo, Rubella and CMV IgM positive for HSV-2 section showed no cross-reactivity.
Interfering Substances
The following compounds have also been tested using Parsagen® ToRCH 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: 2 g/dL
Caffeine: 20 mg/dl
LIMITATIONS
1. Parsagen® ToRCH IgM Combo 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-2 can be determined by this qualitative test.
2. Parsagen® ToRCH IgM Combo Cassette (Serum/Plasma) will only indicate the presence of IgM 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.