inquiry@rdetect.com INTENDED USE:
Human Immunodeficiency Virus 1/2 (HIV1/2) Antibody Test is a rapid and convenient immunochromatographic assay used for the qualitative detection of antibodies against HIV type 1 and type 2 in human serum, plasma and whole blood sample. It is intended for professional use as an aid in diagnosis of HIV infections. This assay provides only a preliminary result and all positive specimens should be confirmed with other qualified assays.
SUMMARY AND EXPLANATION:
The human immunodeficiency virus (HIV) is a lentivirus that causes acquired immunodeficiency syndrome (AIDS). HIV attacks the immune system, lentivirus resulting in a chronic, progressive illness that leads to life-threatening opportunistic infections. There are two types of HIV: HIV-1 and HIV-2. HIV-1 has been isolated from patients with AIDS and AIDS related complexes, and from healthy persons with high potential risks of developing AIDS. Patients with HIV-2 are found primarily in parts of West Africa. Both types are transmitted by sexual contact, through blood, or from mother to child and appear to cause clinically indistinguishable AIDS. HIV infections are staged by CD4 cell counts and clinical symptoms. Not all people progress through all “stages” and the time frames may also vary greatly from person to person. Treatment with anti-retrovirals increases the life expectancy of people infected with HIV.
HIV-1 and HIV-2 are similar in their morphology, cell tropism, host interaction and generic structure. Serological studies have determined that HIV-1 and HIV-2 have multiple common epitopes in core antigens but much less so in the envelope antigens. The clinical diagnostic issues related to HIV are the detection of antibodies to HIV1/2 in human plasma or serum by immunoassay.
Test Procedure:
Allow the test cassette, specimen, buffer, and/or controls to reach room temperature (15-30″C) prior to testing.
1.Bring the pouch to room temperature before opening. Remove the test cassette from the
sealed pouch and use it within one hour.
2.Place the test cassette on a clean and level surface
For Serum or Plasma Specimens
Hold the dropper vertically, draw the specimen and transfer the specimen to the sample well of the test cassette (two drops/approximately 50ul) to the sample well and start the timer. Avoid trapping air bubbles in the sample well.
For Whole Blood Specimens
Hold the dropper vertically, draw the specimen and transfer the specimen to the sample well of the test cassette (two drops/approximately 50ul), then add 1 drop of buffer(approximately 25ul)to the sample well and start the timer. Avoid trapping air bubbles in the sample well.
3. Wait for the colored line(s)to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.
Result Interpretation:
Negative result: if there is only a quality control line C, the detection line is colorless, indicating that HIV1/2 antibody has not been detected and the result is negative.
Positive result: if both the quality control line C and the detection line appear, HIV1 or 2 antibody has been detected and the result is positive.
Invalid result: if the quality control line C is not observed, it will be invalid regardless of whether there is detection line, and the test shall be conducted again.
