First Response HIV 1+2/Syphilis Combo Card Test in Human Serum, Plasma or Whole Blood

【INTENDED USE】

The HIV 1/2 & Syphilis(TP) Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of antibodies to HIV- 1/HIV-2 and antibodies to Treponema Pallidum (TP) in human whole Blood, serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of HIV infection.

【INTRODUCTION】

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, plasma or whole blood 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 differences in their biological characters, 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), a spirochete bacterium with an outer envelope and a cytoplasmic membrane, is the causative agent of the venereal disease syphilis. Although syphilis rates are declining in the United States after an epidemic between 1986 and 1990, the incidence of syphilis in Europe has increased since 1992, especially in the countries of the Russia Federation, where peaks of 263 cases per 100,000 have been reported. In addition, the positive rate of serological test results for syphilis in HIV-infected individuals has been rising recently. The serological detection of specific antibodies to TP has been long recognized in the diagnosis of syphilis since the natural course of the infection is characterized by periods without clinical manifestations. The antibody response to TP can be detected within 4 to 7 days after the syphilis chancre appears, allowing early detection and diagnosis of syphilis infection. A variety of antigens have been used in syphilis serological tests, such as Rapid Plasma Cardiolipin (RPR) or VDRL antigen, TP extracts derived from in vitro culture or inoculated rabbit testes. However, RPR and VDRL antigens are not treponemal specific, and whole TP extracts are not reproducible and contain a certain amount of contaminating materials such as flagella, which may lead to a nonspecific reaction in assays of test serum.

【PRINCIPLE】

The HIV 1/2 Rapid Test detects antibodies to HIV-1/HIV-2 through visual interpretation of color development on the internal strip. Recombinant HIV antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with HIV antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there are sufficient HIV-1/HIV-2 antibodies in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred. The Syphilis Rapid Test detects IgM and IgG antibodies to Treponema Pallidum (TP) through visual interpretation of color development on the internal strip. Specific recombinant TP antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with recombinant TP-specific antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there are sufficient antibodies to Treponema Pallidum (TP) in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

【MAIN CONTENTS】

• Rapid test cassette

• Buffer

• Disposable dropper

• Package insert

【STORAGE AND STABILITY】

• Store at 2 ~ 30 º C in the sealed pouch for 24 months.

• Keep away from direct sunlight, moisture andheat.

• DO NOT FREEZE.

Bring tests, specimens, and/or controls to roomtemperature(15-30°C) before use.
1. Remove the test from its sealed pouch, and placeit onaclean,level surface. Label the test with patient or control identification.For best results, the assay should be performedwithinonehour.
2. Using the provided disposable dropper:
【DIRECTION OF USE】

Bring tests, specimens, and/or controls to roomtemperature(15-30°C) before use. 1. Remove the test from its sealed pouch, and placeit onaclean,level surface. Label the test with patient or control identification.For best results, the assay should be performedwithinonehour.2. Using the provided disposable dropper:

Serum/Plasma
HIV: Transfer 1 drop of serum/plasma to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer.
Syphilis: Transfer 2 drops of serum/plasma to each specimen well (S) of the cassette, then start the timer.
OR
Whole Blood
HIV and Syphilis: Transfer 1 drop of whole blood specimen to each specimen well (S) of the cassette, then add 1 drop of each buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
【INTERPRETATION OF RESULTS】
HIV 1/2:
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
Syphilis:
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.

For further operation or performance details, please refer to final instruction manual.