|Detection Virus:||Human Immunodeficiency Virus||Test Parameter:||HIV-1, HIV-2, Subtype O|
|Principle:||Immunochromatography||Storage:||Room Temperature 2-30℃|
|Origin:||China||Sample:||Whole Blood Serum Plasma|
AIDS Hiv Rapid Test Cassette,
Tri Line Hiv Rapid Test Cassette,
Immunodeficiency Virus Hiv Cassette
A rapid test for the qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) type 1, type 2, and Subtype O in whole blood, serum or plasma.
For professional in vitro diagnostic use only.
INTENDED USE OF HIV TEST
The HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to HIV-1, HIV-2, and Subtype O in whole blood, serum or plasma to aid in the diagnosis of HIV infection.
INTRODUCTION OF HIV TEST
HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from the 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-1 consists of Subtype M and Subtype O. Highly divergent strains of HIV-1 were first recognized in 1990 and grouped provisionally as Subtype O as this variation has similar glycoprotein markers to HIV-1 but a slight variation to the protein marker. Although rarely compared to HIV-1 and HIV-2, infections caused by Subtype O have so far been identified in Africa (Cameroon), France and Germany. HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals.2 HIV-1, HIV-2, and Subtype O all elicit immune responses.3 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.4 Despite the differences in their biological characters, serological activities and genome sequences, HIV-1, HIV-2, and Subtype O show strong antigenic cross-reactivity.5,6 Most HIV-2 positive sera can be identified by using HIV-1 based serological tests.
The HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Single Use Kit (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibodies to HIV-1, HIV2, and/or HIV-1 (O) in whole blood, serum or plasma specimens. The test kit comes with all essential accessories to perform the test as an aid to the clinicians for STAT usage.
The HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Single Use Kit (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibodies to HIV-1, HIV-2, and Subtype O in whole blood, serum or plasma. The membrane is pre-coated with recombinant HIV antigens in the test line regions, T1 and T2. The T1 test line is pre-coated with HIV-1 and Subtype O antigen and the T2 test line is pre-coated with HIV-2 antigen. During testing, the whole blood, serum or plasma specimen reacts with the mixture of HIV-1 envelope and core antigens and HIV-2 envelope antigen that are coated on colored particles in the test strip. 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 Subtype O, or HIV-2, one colored line will appear in the test line region; if the specimen contains antibodies to HIV-1 and/or Subtype O, and HIV-2, two colored lines will appear in the test line region. Both indicate a positive result. If the specimen does not contain HIV-1, Subtype O, and/or HIV-2 antibodies, no colored line will 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.
Rapid Test Cassette in Pouch
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C).
The test is stable through the expiration date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
DO NOT FREEZE.
Do not use beyond the expiration date.
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
Open the small pouch, remove the test device and place it on a clean and level surface. Best results will be obtained if the assay is performed within one hour.
1. Open the large pouch, remove the buffer vial, sterile lancet and other materials. Open the cap of buffer vial without squeezing. Then place it on a clean and level surface.
2. Carefully pull off the cap of sterile lancet
3. Use the provided alcohol swab to clean the puncture site.
4. Push the sterile lancet firmly into the chosen site. Let a large drop of free-flowing blood collect at the puncture site. To increase blood flow, use the thumb and forefinger to gently apply pressure around the puncture site.
5. Add the blood specimen to the test device using either hanging drops or the disposable dropper included in the large pouch.
To use hanging drops:
Turn the hand over and allow 2 hanging drops of whole blood to fall into the center of the specimen well (S) of the test device. DO NOT TOUCH THE SPECIMEN WELL (S) WITH FINGER. Then add 2 drops of buffer into the specimen well (S) and start the timer.
To use the disposable dropper:
Hold the dropper vertically, aspirate the blood from puncture site and dispense 2 drops of whole blood from the dropper in the specimen well (S) on the test device, then add 2 drops of buffer and start the timer. Avoid touching the dropper directly to the finger.
6. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret results after 20 minutes.
NOTE: This test can also be run with serum/plasma specimens according to the following instructions: Add 1 drop of serum or plasma (approximately 25 µL) to the specimen well (S) of the test device, then add 1 drop of buffer, and start the timer. Read results at 10 minutes. Do not interpret results after 20 minutes.