Medical HIV Saliva Rapid Test Kit

Product Description
Intended usage
Diagnostic Kit for Antibody to Human Immunodeficiency Virus (Colloidal Gold) is mainly used for in vitro qualitative detection of antibodies to HIV-1, HIV-2 in human whole blood, serum or plasma, is to aid in clinical diagnosis of HIV infection.
HIV Introduction
The Human Immunodeficiency Virus (HIV) is the causative agent of Acquired Immune Deficiency Syndrome (AIDS). The normal method of detecting infection with HIV is by observing the presence of antibodies to the virus by the ELlSA method, followed by confirmation with the Western Blot Test. Most manufacturers have produced the ELlSA test in a micro titer plate format which requires sophisticated and expensive equipment to obtain a result. Also, it requires highly skilled personnel to perform the test. In many developing world countries the equipment and staff to run these sophisticated tests are limited, and as a result infected blood is still being used for transfusions and many people remain undiagnosed, Labtub® Diagnostic Kit for antibody to Human immunodeficiency Virus (Colloidal Gold) is a qualitative, simple, manual, visual and robust lest that can be used to quickly lest blood for HIV antibodies.
Detection principle
The kit with technology of colloidal gold chromatographic immunoassay, uses double antigen sandwich method for the qualitative detection of antibodies to HIV-1, HIV-2 in human whole blood, serum or plasma. In the detection, when the specimen contains HIV-1 or HIV-2 antibodies, it will form a complex with gold HIV-1 or HIV-2 recombinant antigen coated on glass fibers, the complex was moved along nitrocellulose filter to testing region (T) by chromatography, then the complex is captured by HIV-1 or HIV-2 recombinant antigen coated with testing region (T) on the nitrocellulose filter, a red line appears inside the testing region (T). On the contrary, when the specimen does not contain HIV-1 or HIV-2 antibodies or below the minimum detecting limitation, there is no red line appears inside the testing region (T). The controlling region (C) always appears a red line no matter the specimen contains HIV-1 or HIV-2 antibodies or not.
Main components
Cassette, Dropper, Specimen Diluents, Instructions
Specimen type
Serum, Plasma, Whole blood (including Fingertip blood)
Specimen volume
35μ/test
Detection illustration
Results judgement
Storage conditions
(1) The original packaging should be stored in 4~30°C, a cool, dark, dry place, validity for 18 months.
(2) The cassette should be used immediately after opening.
(3) The kit should be placed under 45°C no more than 60 days, placed in -20°Cfor 6 days, no effect on performance of the kit when repeated freezing and thawing for 3 times in the 6 days.
Product performance indicators
1. Sensitivity
In the internal laboratory study, 100 tests of whole blood (including 30 tests of fingertip blood), 100 tests of serum, 100 tests of plasma were detected by ELA and Western Blot for positive, those samples' detection rate is 100% by the kit.
ELAWestern Blot70 tests of whole blood
(Exclusive fingertip blood)100% positive100% positive30 tests of fingertip blood100% positive100% positive100 tests of serum100% positive100% positive100 tests of plasma100% positive100% positive
Laboratory clinical comparison of reference kits
1. Laboratory clinical comparison with Alere kit
Reference Kit (Alere)TotalPositiveNegativeAssessment Kit (Labtub)Positive3000300Negative0800800Total Amount3008001100
(PPA) =100% (95%CI, 98.74%~100%)
(NPA) =100% (95%CI, 99.52%~100%)
(OPA) =100% (95%CI, 99.65%~100%)
Kappa=1 >0.75; P=0<0.05, it can be considered that there is a high consistency between detection results of the two kinds of kit.
2. Laboratory clinical comparison with Abbott kit
Reference Kit (Abbott)TotalPositiveNegativeAssessment Kit (Labtub)Positive3000300Negative0800800Total Amount3008001100
(PPA) =100% (95%CI, 98.74%~100%)
(NPA) =100% (95%CI, 99.52%~100%)
(OPA) =100% (95%CI, 99.65%~100%)
Kappa=1 >0.75; P=0<0.05, it can be considered that there is a high consistency between detection results of the two kinds of kit.
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