Fine Quality Top Selling iCare Diagnostic HIV 1&2 Oral Swab Rapid Test Kit
The iCARE HIV 1/2 Oral Rapid Screen Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus type 1 and 2 (HIV-1/2) in human oral swab. All positive specimens must be confirmed with Western Blot or other qualified EIA.
Principle
It has been shown that the acquired immunodeficiency syndrome (AIDS) is caused by viruses transmitted via sexual contact, transfusion, or using contaminated blood products such as sharing contaminated needles. HIV-1 and 2 viruses have been isolated from patients with AIDS and AIDS-related complex (ARC), and high risk persons for AIDS. HIV-1/2 viruses deplete T helper cells, a subpopulation of T cells for body defense, thus causing AIDS patients to be susceptible to opportunistic infections and developing malignant tumors. The incidence of specific antibodies to HIV-1/2 is high in AIDS, ARC and persons with high risk for AIDS. The HIV 1/2Oral Rapid Screen Test was designed to detect antibodies to HIV-1/2 in AIDS patients, ARC or high risk persons and identify any potential donors carrying these antibodies in specimens.
The iCARE HIV 1/2 Oral Rapid Screen Test is a chromatographic immunoassay for the detection of antibodies to HIV-1/2 in human oral swab. HIV-1/2 antibodies binding protein are precoated onto a membrane as capture reagents in the Test region (T). During the testing, the oral swab specimen is allowed to react with the colloidal gold reagents which have been labeled with HIV-1/2 specific antigens. If antibodies to HIV-1/2 are present, a pink colored band will develop
on the membrane in proportion to the amount of HIV- 1/2 antibodies present in the specimen. Absence of this pink colored band in the test region (T) suggests a negative result.
Materials Provide
1. 1 Foil pouch containing a test device (assay test cassette) and a desiccant.
2. 1 Mixing chamber (with lid) containing 1 ml of diluent solution
3. 1 Oral swab collector (single pouch)
4. 1 Package insert
Materials Required but not Provide: Timer or clock
Storage and Stability:
The test device is to be stored refrigerated or at room temperature (4-30°C) under dry
conditions for the duration of its shelf life. Do not freeze. The test device is stable through the expiration date printed on the sealed pouch. The test device must be kept sealed in the pouch until use.
Precautions:
1. For in vitro diagnostic use only.
2. Do not use a test device beyond the expiration date imprinted on the back of the foil pouch.
3. Nothing should be placed into the mouth of the subject for at least 15 minutes prior to oral swab collection. This includes food, drink, tobacco products or any other materials.
4. Avoid cross contamination of oral swab samples by using a new oral swab collector and mixing chamber for each sample.
5. Oral swab specimens may be potentially infectious. Properly handle and dispose of all used test devices.
6. All specimens should be treated as if capable of transmitting diseases. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
7. High humidity
Specimen Collection and Storage:
The iCARE HIV 1/2 Oral Rapid Screen Test is designed for the use of buffered human fresh oral swab as the specimen.
1. Remove the oral swab collector from the sealed pouch.
2. Insert the sponge end of the collector into the mouth. Then place sponge in upper gum line
poposition, gently swipe the sponge along the upper gums from one end of mouth to the other end, and back and forth, then swipe the sponge in the same way for the lower gums. (NOTE: Both sides of the sponge end of the collector need to be swabbed along upper gums and lower gums for 5-6 times.)
3. Remove the collector out of the mouth and open the lid of the mixing chamber. Place the saturated collector into the chamber which contains 1 ml diluent solution, and then stir the collector fully along the wall of the chamber. Break off the collector, leaving the sponge end of the collector in the chamber.
4. Close and turn the lid of the chamber tightly and shake and mix the liquid of the chamber well before using (shake up and down about 20 times).
Product Name |
HIV 1&2 Oral Swab Rapid Test Kit |
Packing |
Hospital Version: 40 Tests Per Kit Field Version: 1 Per Foil |
Specimen |
Whole blood / Serum / Plasma |
Type of Test |
Antibody |
Format |
Hospital version: 1 well cassette, pipette, diluent (2 bottles |
Sample |
10ul serum |
Result |
Within 15 minutes |
Specificity |
100% |
Sensitivity |
100% |
Shelf Life |
24 months |
Storage |
Store at 4 ºC ~ 30 ºC in the sealed pouch up to the expiration date. |
JAL Innovation Singapore’s goal is to serve our global partners with a truly integrated biomedical manufacturing facility by offering a wide range of advanced rapid in-vitro immunodiagnostic test systems and electrical biosensing systems, particularly blood glucose monitoring systems for home and professional use. We are committed to serving our partners by manufacturing and distributing high quality, reliable and competitive products and services to every continent. Our vision is to provide safe, reliable and cost effective solutions in markets around the world.
Our range of products includes our in-house brand and iCARE private label brand of diabetic monitoring systems and also the iCARE range of in-vitro diagnostic testing kits, particularly for infectious and sexually transmitted diseases. Our iCare brand of products cover Health Screening, Infectious Diseases, Fertility, Chronic & Critical Illnesses, Alcohol and Drugs of Abuse. We specialize in a range of iCARE blood glucose monitoring systems for capillary blood and alternate site testing to meet every demand of the market.
JAL Innovation production facilities are ISO 13485 and GMP certified.
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