Diagnostic Kit for Antibody to HIV
Features
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 requirements
(1)Collect 1-2 drops of venous whole blood / fingertip blood or 1-2ml of venous blood, get the serum or plasma specimen after centrifuging.
(2) Serum, plasma or whole blood should be placed at 2-8℃ not exceed 7 days, if the detection is arranged after 7 days, the serum, plasma or whole blood should be stored at -20℃ and avoid repeated freezing & thawing.
(3) Can be used for serum, plasma or whole blood specimen anti-coagulated by sodium citrate, heparin, EDTA.
Specimen volume
35μ/test
Detection Method
Please read the instructions carefully before detecting
(l )Preparation: take the cassette from the kit and put it on flat table
(2)Specimen Detection: Drawn serum or plasma or whole blood specimen with dropper, add 1 drop (Approx 35μl) of the specimen to sample well (S)
at the cassette vertically, then add 2 drops (Approx 60μl) of specimen diluents
(3)Results Judgement: The results should be judge within 15 minutes, it is invalid after 15 minutes.
Detection illustration
Results judgement
Positive Result: Each 0f testing region (T) and controlling region (C) appears a red line.
Negative Result: Only the controlling area (C) appears in a red line.
Invalid result: There is no red line in the controlling area (C). Suggest read the instructions carefully again and use the new kit to detect again at that time. If the problem still exists, should stop using this batch kits immediately and contact with local suppliers.
Storage conditions
(1) The original packaging should be stored in 4~30℃, 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℃ no more than 60 days, placed in -20℃for 6 days, no effect on performance of the kit when repeated freezing and thawing for 3 times in the 6 days.
Parameters
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 requirements
(1)Collect 1-2 drops of venous whole blood / fingertip blood or 1-2ml of venous blood, get the serum or plasma specimen after centrifuging.
(2) Serum, plasma or whole blood should be placed at 2-8℃ not exceed 7 days, if the detection is arranged after 7 days, the serum, plasma or whole blood should be stored at -20℃ and avoid repeated freezing & thawing.
(3) Can be used for serum, plasma or whole blood specimen anti-coagulated by sodium citrate, heparin, EDTA.
Specimen volume
35μ/test
Detection Method
Please read the instructions carefully before detecting
(l )Preparation: take the cassette from the kit and put it on flat table
(2)Specimen Detection: Drawn serum or plasma or whole blood specimen with dropper, add 1 drop (Approx 35μl) of the specimen to sample well (S)
at the cassette vertically, then add 2 drops (Approx 60μl) of specimen diluents
(3)Results Judgement: The results should be judge within 15 minutes, it is invalid after 15 minutes.
Detection illustration
Results judgement
Positive Result: Each 0f testing region (T) and controlling region (C) appears a red line.
Negative Result: Only the controlling area (C) appears in a red line.
Invalid result: There is no red line in the controlling area (C). Suggest read the instructions carefully again and use the new kit to detect again at that time. If the problem still exists, should stop using this batch kits immediately and contact with local suppliers.
Storage conditions
(1) The original packaging should be stored in 4~30℃, 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℃ no more than 60 days, placed in -20℃for 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.
Laboratory clinical comparison of reference kits
1. Laboratory clinical comparison with Alere kit
(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
(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.
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.
| ELA | Western Blot | |
|
70 tests of whole blood (Exclusive fingertip blood) |
100% positive | 100% positive |
| 30 tests of fingertip blood | 100% positive | 100% positive |
| 100 tests of serum | 100% positive | 100% positive |
| 100 tests of plasma | 100% positive | 100% positive |
Laboratory clinical comparison of reference kits
1. Laboratory clinical comparison with Alere kit
| Reference Kit (Alere) | Total | |||
| Positive | Negative | |||
| Assessment Kit (Labtub) | Positive | 300 | 0 | 300 |
| Negative | 0 | 800 | 800 | |
| Total Amount | 300 | 800 | 1100 | |
(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) | Total | |||
| Positive | Negative | |||
| Assessment Kit (Labtub) | Positive | 300 | 0 | 300 |
| Negative | 0 | 800 | 800 | |
| Total Amount | 300 | 800 | 1100 | |
(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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