B021 | HIV 1/2 Human Immunodeficiency Virus 1/2 | cassette | 4.0mm | 1T/bag | 20T/box | serum/plasma |
B085 | HIV 1/2 Human Immunodeficiency Virus 1/2 | cassette | 4.0mm | 1T/bag | 20T/box | whole blood |
Priciple:
Used gene recombination HIV1 and HIV2, mixed with antigen P24, gp120, gp41, gp36 and RabMAb HIV antibody coated on nitrocellulose as test line and control line. And meanwhile gold colloid recombination HIV mixed antigen P24, gp120, gp41, gp36, used double antigen sandwich GIA to detect antibody to HIV-1/HIV-2 in human serum or plasma. When the specimen contains HIV antibody, it firstly binds to antigen, formsAntibody-antigen complex, forward by GIA, and then binds to the coated antigen and forms antigen-antibody-antigen complex, showing a macroscopic purplish red line(Test Line), a controlling line on the coated membrane(Control Line) ,
If the C appears, the test is valid, if T appears, showing the specimen contains HIV-1/HIV-2 antibody.
Compositions:
Recombinant HIV antigen mixed ( P24,gp120,gp41,gp36)(Test Line), Rabbit anti-HIV antibodies (Control Line), Recombinant HIV antigen mixed ( P24,gp120,gp41,gp36)(Gold standard pad ).
Requirements on Specimen:
Serum: extract a certain amount of blood with a disposable syringe, place at room temperature until the blood coagulation, clot contraction after centrifugation, and aspirate the serum reserve.
Plasma: extract venous blood with the additions of the vacuum blood anticoagulant (or disposable syringes), transferred to the additions of vascular anticoagulant, repeatedly rocked, separate plasma and blood cells for use.
If the specimen cannot be tested in time, store the specimen 7 days between 2 to 8°C.Over 7 days, store at -20°C.
Test Procedure :
Before the test pls read the instruction manual.Keep the test strip and the specimen back to room temperature to 20-30 °C. If not ready, do not tear foil bag, kits without the package shall be used within 1 hour (20%-90% humidity)
1. Remove the card from the foil bag.
2. Use the dropper, drip one drop (25ul) specimen to the S well.
3. And meanwhile add two drops (80ul-100ul) Sample Diluent into the D well
4. Wait for 15-20 minutes and read results. Over 20 min, the result is invalid.
Result Judgment:
Positive: Two red band appears in the test area (T), another in the control area(C).
Negative: Only control line (C) a red band appears in the detection zone (T) without the red band appears.
Invalid: Quality control area (C) does not appear red band, indicating that the operator error or reagent failure.
Attentions:
1.Do not uses test kit beyond expiry date. Please check the package and the contents are complete before use, if damaged, cannot be used.
2.Test line color intensity level of the sample are not necessarily linked in the antibody titer, Positive results cannot be confirmed as a basis before further confirmatory testing done.
3.The strength of control line does not represent the quality of reagents, the reagent effective as long as its color clearly visible.
4.Samples collected by vacuum blood collection and the proposed butterfly needles, to avoid direct contact with blood.
5.Used Test cards, syringes, needles, straws prior to removal of contamination in the Proposed high-pressure steam sterilization.
Storage and Expiry:
1. Store the kit at 4-30°C. Period of validity is 24 months.
2. Avoid direct sunlight, moisture, away from heat sources. The test card should be used within1 hour once the foil bag opened.
