The HIV1.2 and Syphilis Combo Rapid Test Cassette(Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to HIV type 1, type 2 and syphilis-antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma.
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. 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, 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. Treponema pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete with an outer envelope and a cytoplasmic membrane. Relatively little is known about the organism in comparison with other bacterial pathogens. According to the Center for Disease Control (CDC), the number of cases of Syphilis infection has markedly increased since 1985. Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of prostitution among drug users. One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV
virus and Syphilis. Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation.
The antibodies response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment.
【DIRECTIONS FOR USE】
Allow test cassette, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the Cassette on a clean and level surface.
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul),and start the timer, see illustration below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 ul) to the specimen area, then add 2 drops of buffer (approximately 80 ul), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 50 ul of fingerstick whole blood specimen to the specimen area of test cassette, then add 2 drops of buffer (approximately 80 ul) 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.
Note: It is suggested not to use the buffer, beyond 30 days after opening the vial.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
HIV1.2 POSITIVE:* Two lines appear. One line should be in the control line region (C) and another apparent line should be in the T1 line region (HIV1.2). Syphilis POSITIVE:* Two lines appear. One line should be in the control line region (C) and another apparent line should be in the T2 line region (Syphilis). HIV1.2 and Syphilis POSITIVE:*Three lines appear. One line should be in the control line region (C) and two lines appear in theT1 (HIV1.2) and T2 (Syphilis)regions.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of HIV1.2 and/or Syphilis present in the specimen. Therefore, any shade of color in the HIV1.2 and/or Syphilis region should be considered positive.
NEGATIVE: One line appears in the control line region (C). No line appears in the T1(HIV1.2) and T2(Syphilis) region.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
||HIV1.2 and Syphilis(in one strip) Combo Rapid Test Cassette