High accuracy home use/self-use HIV 1/2 /individual rapid test
Whole blood, plasma,serum
|Product||HIV 1/2 rapid test kit|
|Components||IDisposable pipette, Buffer, Lancets, Alcohol Swab, Package insert|
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 the high potential risk for developing AIDS. HIV-2 has been isolated from West African AIDS patients and 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 shared 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 characters, serological activities and genome sequences, HIV-1 and HIV-2 show strong antigenic cross-reactivity. Most HIV-2 positive sera can be identified
Intend to use
The HIV 1/2 Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to HIV-1/HIV-2 in whole human blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HIV infection.
Specimen and storage
The HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or finger stick), serum, or plasma.
To collect Finger stick Whole Blood specimens:
- Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
- Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
- Add the Fingerpick Whole Blood specimen to the test device by using a capillary tube or hanging drop.
- Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, hemolyzed specimens.
Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature f prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
Bring specimens to room temperature before testing. Frozen specimens must be completely thawed and mixed well before testing. Specimens should not be frozen and thawed repeatedly.
If specimens are to be shipped, they should be packed in com