One Step HSV IgG/IgM Combo Rapid Diagnostic, to detect antibodies
to HSV 1/2 ,Gold colloidal,quickly and easily
Product Name:
One Step Herpes Simplex Virus IgG/IgM Combo Rapid Diagnostic test
One Step HSV IgG/IgM Combo Rapid Diagnostic test
Intended Use:
The HSV 1/2 IgG/IgM Combo Rapid Test Cassette is a lateral flow
chromatographic immunoassay for the qualitative detection of IgG
and IgM antibodies to HSV 1/2 in whole blood, serum or plasma to
aid in the diagnosis of HSV 1/2 infection.
Summary:
HSV 1/2 virus is a member of the Togaviridae family, found mainly
in human populations. Generally rubella is considered a mild
adolescence disease. However a maternal infection could be
transmitted through the placenta to the fetus, causing congenital
rubella. Primary rubella infection contracted during early
pregnancy, may have severe consequences as severe fetal damage,
stillbirth or abortion. Children born asymptomatic may develop
these abnormalities later in life.1,2 Widespread vaccination has
significantly reduced the incidence of rubella in all age groups.
However, 10 to 20% of young adults still appear susceptible to the
virus. To reduce risk of severe complications, accurate serological
methods must be performed to determine the serologic status of
childbearing aged women. The HSV 1/2 IgG/IgM Combo Rapid Test
Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic
immunoassay for the qualitative detection of IgG and IgM antibodies
to rubella virus in whole blood, serum or plasma specimens.
TEST PRINCIPLE
The HSV 1/2 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 HSV 1/2 in whole blood,
serum or plasma specimens. In this test, HSV 1/2 Antigen is coated
in the test line regions of the test. During testing, the whole
blood, serum or plasma specimen reacts with mouse anti-human IgG or
goat anti-human IgM coated particles in the test strip. The mixture
then migrates forward on the membrane by capillary action and
reacts with the HSV 1/2 Antigen 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 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 respective control line regions of all the two 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 cassette from the sealed pouch and use it within
one hour. Best results will be obtained if the assay is performed
as soon as possible.
3. Place the test cassette on a clean and level surface. Hold the
dropper vertically; draw the specimen about 1cm above the upper end
of the nozzle as shown in illustration below. Transfer 1 full drop
(approx. 20μL) of specimen to each sample well, then add 2 drops of
buffer (approximately 80μL) to each sample well and start the
timer. See the illustration below.
4. Wait for the colored line(s) to appear. The result should be
read at 15 minutes. Do not interpret results 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 CHARACTERS:
Sensitivity and Specificity
The HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole
Blood/Serum/Plasma) was compared with leading commercial EIA HSV
1/2 tests; the results show that HSV 1/2 IgG/IgM Combo Rapid Test
Cassette (Whole Blood/Serum/Plasma) has a high sensitivity and
specificity.
| 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%)
| 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%)
NOTE: Insufficient specimen volume or incorrect procedural techniques
are the most likely reasons for the control line failure. Review
the procedure and repeat the test with a new device. If problem
persists, please contact your local distributor.
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
