Multiple Cassette ToRCH Test Kit Strip 5-15 Mins Testing Time CE Certiication

multiple cassette ToRCH IgG/IgM Combo Rapid Test device ,gold colloidal method,Blood/serum/plasma

 

 

Product Name: One Step ToRCH IgG/IgM Combo Rapid Diagnostic Test Cassette

 

 

Intended Use:

 

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

 

Summary:

 

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 1/2 – Herpes Simplex Virus 1 and/or 2 (Virus). The infections usually cause few, if any, symptoms in the pregnant woman, but pose greater risks of serious birth defects for neonates. Infections caused by ToRCH – Toxoplasma, Rubella Virus, Cytomegalo Virus (CMV) and Herpes Simplex Virus (HSV) – is the major cause of BOH (Bad Obstetric History).2 Risks are severe, if the mother gets the infection in the first trimester as the baby's organs start to form in this stage. General symptoms include premature birth, growth retardation, neurological abnormalities, and damage of the eye, liver, heart and ear as well as bone lesions. Microcephaly, hydrocephaly, seizures and psychomotor retardation accompany these malformations.

 

The ToRCH IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies and IgM antibodies to Toxo, Rubella, CMV, and HSV 1/2 in whole blood, serum or plasma specimens.

 

TEST PRINCIPLE

 

The ToRCH IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of IgG and IgM antibodies to Toxoplasma, Rubella, CMV and HSV 1/2 in whole blood, serum or plasma specimens. In this test, mouse anti-human IgG and mouse anti-human IgM are coated in the test line regions of the test. During testing, the whole blood, serum or plasma specimen reacts with Toxoplasma antigen, Rubella antigen, CMV antigen and HSV 1/2 antigen coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the mouse anti-human IgG or mouse anti-human IgM on the membrane in the test line region. The presence of a colored line in the test line region indicates a positive result for Toxoplasma, Rubella, CMV or HSV 1/2 infection, while its absence indicates a negative result for that infection.To serve as a procedural control, a colored line will always appear in the control line region of the strip indicating that proper volume of specimen has been added and membrane wicking has occurred

 

TEST PROCEDURE

 

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

 

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

 

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

 

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

 

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

 

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

 

INTERPRETATION OF RESULTS

 

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

 

Negative:

The control line appears in the result window, but the test line is not visible.

 

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

 

PERFORMANCE CHARACTERISTICS

 

Sensitivity and Specificity

 

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

 

TOXO IgG

Method		T.Gondii EIA (IgG)		Total Results
Toxo IgG Rapid Test Cassette	Results	Positive	Negative
	Positive	48	6	54
	Negative	2	394	396
Total Results		50	400	450

 

Relative Sensitivity: 96.0% (95%CI*: 86.3%-99.5%) *Confidence Interval

 

Relative Specificity: 98.5% (95%CI*: 96.8%-99.4%)

 

Accuracy: 98.2% (95%CI*: 96.5%-99.2%)

 

 

TOXO IgM

 

Method		T.Gondii EIA (IgM)		Total Results
Toxo IgM Rapid Test Cassette	Results	Positive	Negative
	Positive	47	5	52
	Negative	3	395	398
Total Results		50	400	450

 

 

Relative Sensitivity: 94.0% (95%CI*: 83.5%-98.7%) *Confidence Interval

 

Relative Specificity: 98.8% (95%CI*: 97.1%-99.6%)

 

Accuracy: 98.2% (95%CI*: 96.5%-99.2%)

 

 

Rubella IgG

Method		Rubella EIA (IgG)		Total Results
Rubella IgG Rapid Test Cassette	Results	Positive	Negative
	Positive	56	4	60
	Negative	5	306	311
Total Results		61	310	371

 

Relative Sensitivity: 91.8% (95%CI*: 81.9%-97.3%) *Confidence Interval

 

Relative Specificity: 98.7% (95%CI*: 96.7%-99.6%)

 

Overall Accuracy: 97.6% (95%CI*: 95.4%-98.9%)

 

 

Rubella IgM

 

Method		Rubella EIA (IgM)		Total Results
Rubella IgM Rapid Test Cassette	Results	Positive	Negative
	Positive	57	3	60
	Negative	4	307	311
Total Results		61	310	371

 

Relative Sensitivity: 93.4% (95%CI*: 89.4%-99.9%) *Confidence Interval

 

Relative Specificity: 99.0% (95%CI*: 97.2%-99.8%)

 

Overall Accuracy: 98.1% (95%CI*: 96.2%-99.2%)

 

 

CMV IgG

 

Method		CMV EIA (IgG)		Total Results
CMV IgG Rapid Test Cassette	Results	Positive	Negative
	Positive	43	4	47
	Negative	3	321	324
Total Results		46	325	371

 

Relative Sensitivity: 93.5% (95%CI*: 82.1%-98.6%) *Confidence Interval

 

Relative Specificity: 98.8% (95%CI*: 96.9%-99.7%)

 

Accuracy: 98.1% (95%CI*: 96.2%-99.2%)

 

 

 

CMV IgM

Method		CMV EIA (IgM)		Total Results
CMV IgM Rapid Test Cassette	Results	Positive	Negative
	Positive	36	4	40
	Negative	3	328	331
Total Results		39	332	371

 

Relative Sensitivity: 92.3% (95%CI*: 79.1%-98.4%) *Confidence Interval

 

Relative Specificity: 98.8% (95%CI*: 96.9%-99.7%)

 

Accuracy: 98.1% (95%CI*: 96.2%-99.2%)

 

 

 

HSV 1/2 IgG

Method		HSV 1/2 EIA (IgG)		Total Results
HSV 1/2 IgG Rapid Test Cassette	Results	Positive	Negative
	Positive	33	5	38
	Negative	2	300	302
Total Result		35	305	340

 

Relative Sensitivity: 94.3% (95%CI*: 80.8%-99.3%) *Confidence Interval

 

Relative Specificity: 98.4% (95%CI*: 96.2%-99.5%)

 

Accuracy: 97.9% (95%CI*: 95.8%-99.2%)

 

 

 

HSV 1/2 IgM

 

Method		HSV 1/2 EIA (IgM)		Total Results
HSV 1/2 IgM Rapid Test Cassette	Results	Positive	Negative
	Positive	32	4	36
	Negative	3	301	304
Total Result		35	305	340

 

Relative Sensitivity: 91.4% (95%CI*: 76.9%-98.2%) *Confidence Interval

 

Relative Specificity: 98.7% (95%CI*: 96.7%-99.6%)

 

Accuracy: 97.9% (95%CI*: 95.8%-99.2%)

 

ORIENT NEW LIFE MEDICAL CO., LTD.
Contact:	Jerry Meng
Email:	Jerry @ newlifebiotest .com
Tel.	+86 18657312116
SKYPE	enetjerry