99% accuracy HCV Home Testing kits, full individual package, home
test use, detecting Hepatitis C virus
INTENDED USE:
The HCV Home Testing kit is a rapid chromatographic immunoassay for
the qualitative detection of antibodies to Hepatitis C Virus in
blood for the self test at home.
INTRODUCTION
The current diagnosis of HCV infection relies primarily on the
detection of HCV specific antibodies and/or clinical symptoms not
attributed to Hepatitis A, B, D or E. The transmission of HCV has
been reported to be via transfusion of contaminated blood or blood
products as well as shared needles and close personal contact with
an infected individual.
The HCV Home Testing kit is a rapid test to qualitatively detect
the presence of antibodies to HCV in a serum or plasma sample. The
test utilizes a combination of protein A coated particles and
recombinant HCV proteins to selectively detect antibodies to HCV in
serum or plasma. The recombinant HCV proteins used in the test kit
are encoded with the genes for both structural (nucleocapsid) and
non-structural proteins.
The availability of a rapid, simple test for HCV will enable HCV
testing in urgent situations such as transplant and grafting
procedures. Such a test will also allow small private laboratories
to perform the assay in-house rather than referring the sample to
the reference centre. The HCV Rapid Test may also be utilized by
large reference centres or blood transfusion centres as a second
assay when they are required to perform two methods on each
reactive sample.
PRINCIPLE
The HCV Rapid Test utilizes a combination of protein A coated
particles and recombinant antigens derived from HCV structural and
non-structural sequences. The presence of antibodies is revealed by
a reaction of antibodies with protein A coated particles and
subsequent binding to recombinant HCV antigen that generates a red
line on the membrane.
An internal sample/ reagent addition control is also included in
the device to minimize the risk of a false negative reaction due to
operational errors.
TEST PROCEDURE
Ensure that test device and sample are brought to room temperature
(15oC - 30oC) before testing. Remove device from foil pouch and use
within one hour. Place device on a clean and level surface.
1. Hold the sample applicator vertically and draw the sample up to
the Fill Line as shown in the illustration below (approximately 5
µl). Transfer the sample to Sample well (S) of test device.
2. Then add 2 full drops of buffer (approximately 80 µl). Avoid air
bubbles in the specimen well.
3. Start the timer and read the results at 10 minutes. Do not read
the results after 20 minutes.
PERFORMANCE CHARACTERISTICS
Sensitivity
The HCV Home Testing kit has been tested with a seroconversion
panel and compared with leading commercial HCV EIA test using
clinical samples.
Specificity
The recombinant antigens used for the HCV Home Testing kit are
encoded by genes for both structural (nucleocapsid) and
non-structural proteins. The HCV Home Testing kit is highly
specific for antibodies to Hepatitis C Virus compared with a
leading commercial HCV EIA test.
| Method | EIA | | Total |
| HCV | Results | Positive | Negative | Results |
| Test | Positive | 92 | 20 | 112 |
| Device | Negative | 3 | 1888 | 1891 |
| TOTAL RESULTS | 95 | 1908 | 2003 |
Relative Sensitivity: 96.8%
Relative Specificity: 99.0%
Accuracy: 98.9%
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
