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INTENDED USE:
The HIV Saliva Home Testing kits is a point-of-care test to aid in
the diagnosis of infection with HIV-1 and HIV-2. This rapid HIV
test provides results with 99.30% accuracy from oral fluid in as
little as 20 minutes, thus providing results during the initial
visit and enabling immediate counseling. Additionally, this test
will be useful for pregnant women who do not know their HIV status
at the time of delivery and for health care workers after
accidental exposures to body fluids from infected individuals.
INTRODUCTION
Acquired Immune Deficiency Syndrome (AIDS), AIDS related complex
(ARC) and pre-AIDS are thought to be caused by the Human
Immunodeficiency Virus (HIV). The first AIDS-related virus, HIV-1
(also known as HTLV-III, LAV-1 and ARV) has been isolated from
patients with AIDS and from healthy persons at high risk for AIDS.
Genetic analysis of HIV-1 isolates has documented the existence of
subtypes. To date, eight HIV-1 subtypes (A through H), designated
as Group M, have been identified world-wide in addition to the
highly divergent HIV-1 isolates from AIDS patients in Cameroon,
designated as Group O.3 A closely related but distinct second type
of pathogenic human immunodeficiency retrovirus, designated HIV-2
(formerly LAV-2), has been isolated from West African patients with
AIDS. HIV-2 has been shown to share a number of conserved sequences
with HIV-1, but serological cross-reactivity between HIV-1 and
HIV-2 has been shown to be highly variable from sample to sample.
HIV is known to be transmitted by sexual contact, by exposure to
blood (including sharing contaminated needles and syringes) or by
contaminated blood products, or it may be transmitted from an
infected mother to her fetus during the prenatal period.
Individuals infected with HIV produce antibodies against the HIV
viral proteins. Testing for the presence of antibodies to HIV in
bodily fluids (e.g., blood, oral fluid, and urine) is an accurate
aid in the diagnosis of HIV infection. However, the implications of
seropositivity must be considered in a clinical context. For
example, in neonates, the presence of antibodies to HIV is
indicative of exposure to HIV, but not necessarily of HIV
infection, due to the acquisition of maternal antibodies that may
persist for up to eighteen months. Conversely, absence of antibody
to HIV cannot be taken as absolute proof that an individual is free
of HIV infection or incapable of transmitting the virus. An
antibody response to a recent exposure may take several months to
reach detectable levels. HIV has been isolated from asymptomatic,
seronegative individuals presumably before seroconversion following
exposure.
The standard laboratory HIV testing algorithm used in the United
States consists of screening with an enzyme immunoassay (EIA) and
confirmation of repeatedly reactive EIAs using a Western blot test.
Results are typically reported within 48 hours to 2 weeks, making
these standard screening and supplemental tests inadequate to meet
the need for rapid HIV diagnosis. The HIV-1/2 Saliva Antibody Home
Test kit is a point-of-care test to aid in the diagnosis of
infection with HIV-1 and HIV-2.
TEST PRINCIPLE
The HIV-1/2 Saliva Antibody Home Test kit is a manually performed,
visually read, 20 minute immunoassay for the qualitative detection
of antibodies to HIV-1 and HIV-2 in human oral fluid. The HIV-1/2
Saliva Antibody Home Test kit is comprised of a single-use test
device and a single-use vial containing a pre-measured amount of a
buffered developer solution. Each component is sealed in separate
compartments of a single pouch to form the test. The HIV-1/2 Saliva
Antibody Home Test kit utilizes a proprietary lateral flow
immunoassay procedure. The device plastic housing holds an assay
test strip comprised of several materials that provide the matrix
for the immunochromatography of the specimen and the platform for
indication of the test results.
The assay test strip, which can be viewed through the test device
result window, contains synthetic peptides representing the HIV
envelope region and a goat anti-human IgG procedural control
immobilized onto a nitrocellulose membrane in the Test (T) zone and
the Control (C) zone, respectively.
An oral fluid specimen is collected using the flat pad on the test
device, followed by the insertion of the test device into the vial
of developer solution. As the specimen continues to migrate up the
strip, it encounters the T zone. If the specimen contains
antibodies that react with the antigens immobilized on the
nitrocellulose membrane, a reddish-purple line will appear,
qualitatively indicating the presence of antibodies to HIV-1 and/or
HIV-2 in the specimen. The intensity of the line color is not
directly proportional to the amount of antibody present in the
specimen.
Further up the assay strip, the sample will encounter the C zone.
This built-in procedural control serves to demonstrate that a
specimen was added to the vial and that the fluid has migrated
adequately through the test device. A reddish-purple line will
appear in the C zone during the performance of all valid tests,
whether or not the sample is positive or negative for antibodies to
HIV-1 and/or HIV-2 (refer to the Test Result and Interpretation of
Test Result section below).
The test results are interpreted after 20 minutes but not more than
40 minutes after the introduction of the test device into the
developer solution containing the test specimen. No precision
pipeting, predilutions, or specialized instrumentation are required
to perform the HIV-1/2 Saliva Antibody Home Test kit.
TEST PROCEDURE
- Before test, please gargle gently with warm boiled water, do not
drink or eat for half an hour before collect specimen.
- Place the flat pad above the teeth against the outer gum. Gently
swab completely around the outer gums, both upper and lower, one
time around, using the flat pad. Do not swab the roof of the mouth,
the inside of the cheek or the tongue.
- Carry the flat pad to the test stand and insert the flat pad into
the tube of developer solution. Be sure that the result window
faces forwarded, the flat pad touches the bottom of the developer
solution vial.
- Do not cover the two holes in the back of the test device after
placing it into the developer solution. Doing so may cause an
invalid result. Leave the test device in the developer solution
vial and start a timer. Do not move the test stand, or remove the
test device from the vial once the test dev9ice has been inserted,
until you have read the results.
- Read the results after at least 20 minutes but not more than 40
minutes in a well-lighted area.
- Read the results: Note whether there is a band opposite the “ C”
AND “ T” area.
INTERPRETATION OF RESULTS
Positive:
Two pink lines appear in the result window. This indicates that the
specimen contains detectable amount of H. Pylori antibody.
Negative:
Only one pink line appears in the control region (C). This
indicates that there is no detectable H. Pylori antibody in
specimen.
Invalid:
No colored line appears in the control region regardless of the
presence or absence of the test line.
PERFORMANCE STUDY
Detection of Antibody to HIV-1 in Oral Fluid Specimens from HIV-1
Seropositive Individuals
| | | | |
| Total | | Repeatedly | True Positive1 |
| Test Group | Samples | Reactive | Reactive |
| Known HIV-1 | | | | |
| Positive | 767 | 762 | 764 | 767 |
| High-Risk | 3150 | 722 | 743 | 73 |
| TOTAL | 3917 | 834 | 838 | 840 |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
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