Product features |
Parameters |
Principle |
Chromatographic Immunoassay |
Format |
Cassette |
Specimen |
WB/S/P |
Reading Time |
10 minutes |
Pack |
1T |
Storage Temperature |
2-30°C |
Shelf Life |
2 Years |
HIV 1.2 Rapid Test Cassette Single Use Kit, diagnosis of Human Immunodeficiency Virus
A rapid test for the diagnosis of Human Immunodeficiency Virus to detect antibodies to HIV type 1 and type 2 qualitatively in Whole Blood.
For professional in vitro diagnostic use only.
INTENDED USE
The HIV1.2 Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus(HIV) type 1 and type 2 in whole blood to aid in the diagnosis of HIV infection.
SUMMARY
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.1 HIV 2 has been isolated from West
African AIDS patients and from seropositive asymptomatic individuals.2 Both HIV 1 and HIV 2 elicit immune response. Detection of HIV antibodies in serum, plasma 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.4 Despite the differences in their biological characteristics, 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. The HIV 1.2 Rapid Test Cassette is a rapid test to qualitatively detect the presence of antibody to HIV 1 and/or HIV 2 in whole blood specimen. The test utilizes latex conjugate and multiple recombinant HIV proteins to selectively detect antibodies to the HIV 1.2 in whole blood.
PRINCIPLE
The HIV 1.2 Rapid Test Cassette is a qualitative, membrane based immunoassay for the detection of antibodies to HIV 1.2 in whole blood. The membrane is pre-coated with recombinant HIV antigens. During testing, the whole blood specimen reacts with HIV antigen coated particles in the test Cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with recombinant HIV antigen on the membrane in the test line region. If the specimen contains antibodies to HIV 1 and/or HIV 2, a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain HIV 1 and/or HIV 2 antibodies, a colored line will not appear in the test line region, indicating a negative result.
To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of
specimen has been added and membrane wicking has occurred.
REAGENTS
The test contains HIV1.2 recombinant antigens coated particles and HIV1.2 recombinant antigens coated on the membrane.
DIRECTIONS FOR USE
Allow the test pack to equilibrate to room temperature (15-30°C) prior to testing.
1. Open the small part of the pouch, remove the test cassette and place it on a clean and level surface. Run the testing within one hour and best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Open the large part of the pouch, remove the transfer pipette, buffer vial, sterile lancet and alcohol swab, place them close to the test cassette. Twist off the tab of the buffer vial without squeezing and keep it ready for testing.
3. Use the provided alcohol swab to clean the fingertip of the middle finger as the puncture site.
4. Carefully pull off the sterile lancet cap. Push the sterile lancet firmly into the fingertip of the middle finger. Do not use the first drop of blood. To increase blood flow, use the thumb and forefinger to gently apply pressure around the puncture site.
5. Hold the disposable transfer pipette vertically and aspirate the blood drop from puncture site. Dispense 2 drops of blood (approx. 50μL) from the transfer pipette into the specimen well (S) on the test cassette, and then add 2 drops of buffer (approx. 80μL). Avoid touching the transfer pipette directly to the fingertip. Start the timer.
6. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret results after 20 minutes.
【INTERPRETATION OF RESULTS】
(Please refer to the illustration above)
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of HIV antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test Cassette immediately and contact your local distributor.
Order Information
IHI-402 |
HIV 1.2 Rapid Test Cassette |
WB/S/P |
Cassette |
25 T |
IHI-CT402H |
HIV 1.2 Rapid Test |
WB |
Cassette |
1 T |
IHI-T402 |
HIV 1.2.O Rapid Test Cassette |
WB/S/P |
Cassette |
25 T |
IHIG-402 |
HIV p24 Antigen Rapid test Cassette |
WB/S/P |
Cassette |
25 T |
IHIBG-425 |
HIV 1.2 and HIV p24 Combo Rapid Test Cassette |
WB/S/P |
Cassette |
25 T |
IHIBG-402 |
HIV 1.2 and HIV p24 Combo Rapid Test Cassette |
WB/S/P |
Cassette |
25 T |
IHIBG-CTT402 |
HIV 1.2.O and HIV p24 Combo Rapid Test Cassette |
WB/S/P |
Cassette |
25 T |
IHI-CT102 |
HIV 1.2 Rapid Test |
Urine |
Cassette |
25 T |
IHI-CT102H |
HIV 1.2 Home Rapid Test |
Urine |
Cassette |
1 T |
IHI-CT802 |
HIV 1.2 Rapid Test |
Oral fluid |
Cassette |
20 T |
IHI-CT802H |
HIV 1.2 Home Rapid Test |
Oral fluid |
Cassette |
1 T |