Syphilis/HIV1.2 Combo Rapid Test Cassette
¡¾SUMMARY¡¿
The HIV 1.2 Rapid Test (Serum/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 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 Syphilis Rapid Test (Serum/Plasma) utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect TP antibodies (IgG and IgM) qualitatively and selectively in serum or plasma. Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium 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 numbers of cases of Syphilis infection has markedly increased since 1985. Some key factors that have contributed to this rise include the crackcocaine epidemic and the high incidence of prostitution among drug users. One studyreported 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.
¡¾DIRECTIONS FOR USE¡¿
Allow test cassette, specimen, bufferand/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 test cassette on a clean and level surface. Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 ul) to the specimen well, then add 1 drop of buffer (approximately 40 ul), respectively. Start the timer. See the illustration below.
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.
Note: It is suggested not to use the buffer, beyond 30 days after opening the vial.
The HIV 1.2 Rapid Test (Serum/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 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 Syphilis Rapid Test (Serum/Plasma) utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect TP antibodies (IgG and IgM) qualitatively and selectively in serum or plasma. Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium 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 numbers of cases of Syphilis infection has markedly increased since 1985. Some key factors that have contributed to this rise include the crackcocaine epidemic and the high incidence of prostitution among drug users. One studyreported 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.
¡¾DIRECTIONS FOR USE¡¿
Allow test cassette, specimen, bufferand/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 test cassette on a clean and level surface. Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 ul) to the specimen well, then add 1 drop of buffer (approximately 40 ul), respectively. Start the timer. See the illustration below.
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.
Note: It is suggested not to use the buffer, beyond 30 days after opening the vial.
| Cat. No. | Product Description | Specimen | Format | Kit Size | Cut-Off | Status |
| IMID-325 | Syphilis/HIV1.2 Combo Rapid Test Cassette | S / P | Cassette | 25 T | See Insert | Non-CE |
