ToRCH IgM Rapid Test device , 4mm cassette, gold colloidal
method,Blood test, easily use
Intended Use:
ToRCH IgM Combo Rapid Test Cassette 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 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 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
Toxo IgM Rapid Test:
In this test, 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 T.gondii 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 IgM on the
membrane in the test line region respectively. The presence of a
colored line in the test line region indicates a positive result
for T.gondii infection, while its absence indicates a negative
result for that infection.
Rubella IgM Rapid Test/CMV IgM Rapid Test/HSV 1/2 IgM Rapid Test:
In this test, antigens of Rub, CMV and HSV 1/2 are coated in the
test line regions of each section in the test. During testing, the
whole blood, serum or plasma specimen reacts with Goat anti-human
IgM coated particles in the test strip. The mixture then migrates
upward on the membrane by capillary action and reacts with the Rub,
CMV and HSV 1/2 specific antigens on the membrane in the test line
regions of the respective sections. The presence of a colored line
in the test line region of a particular section indicates a
positive result for the corresponding infection, viz. Rub, CMV, HSV
1/2, while its absence indicates a negative result for that
infection.
To serve as a procedural control, a colored line will always appear
in the respective control line regions of all the four strips
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 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 IgM Combo Rapid Test
Cassette has a high sensitivity and specificity for each of its
sections.
TOXO
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
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
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 | 37 |
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
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 |