Human Immunodeficiency Virus HIV 1/2 Rapid Test Kit Cassette Format 24 Months Shelf Life
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Detailed Product Description
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Human Immunodeficiency Virus (HIV 1/2) Rapid Test Diagnostic Test Kit
【INTENDED USE】 The HIV 1/2 Rapid Test (Whole Blood /Serum/Plasma) is a rapid
visual immunoassay for the qualitative, presumptive detection of
antibodies to HIV- 1/HIV-2 in human Whole Blood, serum or plasma
specimens. This kit is intended for use as an aid in the diagnosis
of HIV infection. 【INTRODUCTION】 HIV is the etiologic agent of Acquired Immune Deficiency Syndrome
(AIDS). The virion is surrounded by a lipid envelope that is
derived from host cell membrane. Several viral glycoproteins are on
the envelope. Each virus contains two copies of positive-sense
genomic RNAs. HIV-1 has been isolated from patients with AIDS and
AIDS-related complex, and from healthy people with high potential
risk for developing AIDS. HIV-2 has been isolated from West African
AIDS patients and from seropositive asymptomatic individuals. Both
HIV-1 and HIV-2 elicit immune response. Detection of HIV antibodies
in serum, plasma or whole blood is the most efficient and common
way to determine whether an individual has been exposed to HIV and
to screen blood and blood products for HIV. Despite differences in
their biological characters, serological activities and genome
sequences, HIV-1 and HIV-2 show strong antigenic cross-reactivity.
Most HIV-2 positive sera can be identified by using HIV-1 based
serological tests. 【PRINCIPLE】 The HIV 1/2 Rapid Test (Whole Blood/Serum/Plasma) detects
antibodies to HIV-1/HIV-2 through visual interpretation of color
development on the internal strip. Recombinant HIV antigens are
immobilized on the test region of the membrane. During testing, the
specimen reacts with HIV antigen conjugated to colored particles
and precoated onto the sample pad of the test. The mixture then
migrates through the membrane by capillary action and interacts
with reagents on the membrane. If there are sufficient HIV-1/HIV-2
antibodies in the specimen, a colored band will form at the test
region of the membrane. The presence of this colored band indicates
a positive result, while its absence indicates a negative result.
The appearance of a colored band at the control region serves as a
procedural control, indicating that the proper volume of specimen
has been added and membrane wicking has occurred.
【CONTENTS】 • Rapid test cassette with desiccant. • Buffer • Disposable pipettes • Package insert 【STORAGE AND STABILITY】 • Store at 2 ~ 30 º C in the sealed pouch for 24 months. • Keep away from direct sunlight, moisture and heat. • DO NOT FREEZE. 【SAMPLE COLLECTION AND STORAGE】 • The HIV 1/2 Rapid Test is intended for use with human whole
blood, serum or plasma specimens only. • Only clear, non-hemolyzed specimens are recommended for use with
this test. Serum or plasma should be separated as soon as possible
to avoid hemolysis. • Perform testing immediately after specimen collection. Do not
leave specimens at room temperature for prolonged periods. Serum
and plasma specimens may be stored at 2-8°C for up to 3 days. For
long term storage, specimens should be kept below -20°C. • Bring specimens to room temperature prior to testing. Frozen
specimens must be completely thawed and mixed well prior to
testing. Avoid repeated freezing and thawing of specimens. • If specimens are to be shipped, pack them in compliance with all
applicable regulations for transportation of etiological agents. • Icteric, lipemic, hemolysed, heat treated and contaminated sera
may cause erroneous results. 【PRECAUTIONS】 • For professional in vitro diagnostic use only. • Do not use after the expiration date indicated on the package. Do
not use the test if the foil pouch is damaged. Do not reuse tests. • This kit contains products of animal origin. Certified knowledge
of the origin and/or sanitary state of the animals does not
completely guarantee the absence of transmissible pathogenic
agents. It is therefore recommended that these products be treated
as potentially infectious, and handled by observing usual safety
precautions (e.g., do not ingest or inhale). • Avoid cross-contamination of specimens by using a new specimen
collection container for each specimen obtained. • Read the entire procedure carefully prior to testing. • Do not eat, drink or smoke in the area where the specimens and
kits are handled. Handle all specimens as if they contain
infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow
standard procedures for the proper disposal of specimens. Wear
protective clothing such as laboratory coats, disposable gloves and
eye protection when specimens are assayed. • Humidity and temperature can adversely affect results. • Used testing materials should be discarded according to local
regulations. 【OPERATION】 Bring tests, specimens, and/or controls to room temperature
(15-30°C) before use. 1.Remove the test from its sealed pouch, and place it on a clean,
level surface.Label the test with patient or control
identification. For best results, the assay should be performed
within one hour. 2.Using the provided disposable pipette, transfer 2 drops of
serum/Plasma to the specimen well (S) of the cassette with the
provided disposable pipette, then start the timer. OR Transfer 1 drop of whole blood specimen to the specimen well (S) of
the device with the provided disposable pipette, then add 1 drop of
buffer and start the timer. OR Allow 2 hanging drops of fingerstick whole blood specimen to fall
into the center of the specimen well (S) on the cassette, then add
1 drop of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add
any solution to the result area. As the test begins to work, color will migrate across the membrane. 3. Wait for the colored band(s) to appear. The result should be
read at 15 minutes. Do not interpret the result after 20 minutes. 【INTERPRETATION OF RESULTS】 POSITIVE: The presence of two lines as control line (C) and test line (T)
within the result window indicates a positive result. NEGATIVE: The presence of only control line (C) within the result window
indicates a negative result. INVALID: If the control line (C) is not visible within the result window
after performing the test, the result is considered invalid. Some
causes of invalid results are because of not following the
directions correctly or the test may have deteriorated beyond the
expiration date. It is recommended that the specimen be re-tested
using a new test. For further operation or performance details, please refer to final instruction manual.
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| Product Tags: Cassette Format Rapid Test Kit HIV 1/2 Rapid Test Kit Human Immunodeficiency Virus Rapid Test Kit |
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