【SUMMARY】
HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The
virion is surrounded by a lipid envelope that is derived from host cell
membrane. Several viral glycoproteins are on the envelope. Each virus contains
two copies of positive-sense genomic RNAs. HIV 1 has been isolated from
patients with AIDS and AIDS-related complex, and from healthy people with high
potential risk for developing AIDS. 1 HIV 2 has been isolated from West African
AIDS patients and from seropositive asymptomatic individuals. Both HIV 1 and
HIV 2 elicit immune response. Detection of HIV antibodies in whole blood, serum
or plasma is the most efficient and common way to determine whether an
individual has been exposed to HIV and to screen blood and blood products for
HIV. Despite the differences in their biological characteristics, serological
activities and genome sequences, HIV 1 and HIV 2 show strong antigenic
cross-reactivity. Most HIV 2 positive sera can be identified by using HIV 1
based serological tests.
The HIV 1.2 Rapid Test Strip (Whole Blood/Serum/Plasma) is a rapid test to
qualitatively detect the presence of antibody to HIV 1 and/or HIV 2 in whole
blood, serum or plasma specimen. The test utilizes latex conjugate and multiple
recombinant HIV proteins to selectively detect antibodies to the HIV 1.2 in
whole blood, serum or plasma.
【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C)
prior to testing.
1.Bring the pouch to room temperature before opening it. Remove the test strip
from the sealed pouch and use it as soon as possible.
2.Place the test cards on a clean and level desk, then peel off the strip label
of the test cards, stick the test strip onto it as soon as possible before
testing.
For Serum or Plasma specimen:
Hold the dropper vertically and transfer 2 drops of serum or plasma
(approximately 50 μl) to the specimen area, then add 1 drop of buffer
(approximately 40 μl),and start the timer, see illustration below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer
2 drops of whole blood (approximately 50μl) to the specimen area, then add1
drop of buffer (approximately 40μl), and start the timer. See illustration
below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately
50m mL of fingerstick whole blood specimen to the specimen area of test strip,
then add 1 drop of buffer (approximately 40 μl) and start the timer. See
illustration below.
· To use hanging drops: Allow 2 hanging drops of fingerstick whole blood
specimen (approximately 50 μl) to fall into the specimen area of test strip,
then add 1 drop of buffer (approximately 40 μl) and start the timer. See
illustration below.
3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not
interpret the result after 20 minutes.