A rapid test for the qualitative detection of Hepatitis B surface antigen (HBsAg), antibodies to Hepatitis C Virus and HIV type 1 plus type 2 in human whole blood, serum or plasma specimen.
For professional in vitro diagnostic use only.
【INTENDED USE】
The HCV/HBsAg/HIV 1.2 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg), antibodies to Hepatitis C Virus and HIV type 1 plus type 2 in human whole blood, serum or plasma specimen.
【SUMMARY】
Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA Virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibody to HCV is found in over 80% of patients with well-documented non-A, non-B hepatitis.
Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens.2,3 Compared to the first generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity and to increase the sensitivity of the HCV antibody tests.4,5 Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus. The complex antigen found on the surface of HBV is called HBsAg. Previous designations included the Australia or Au antigen.1 The presence of HBsAg in serum or plasma is an indication of an active Hepatitis B infection, either acute or chronic. In a typical Hepatitis B infection, HBsAg will be detected 2 to 4 weeks before the ALT level becomes abnormal and 3 to 5 weeks before symptoms or jaundice develop. HBsAg has four principal subtypes: adw, ayw, adr and ayr. Because of antigenic heterogeneity of the determinant, there are 10 major serotypes of Hepatitis B virus. 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.6 HIV 2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals.7 Both HIV 1 and HIV 2 elicit immune response.8 Detection of HIV antibodies in 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.9 Despite the differences in their biological characteristics, serological activities and genome sequences, HIV 1 and HIV 2 show strong antigenic cross-reactivity.10,11 Most HIV 2 positive sera can be identified by using HIV 1 based serological tests.
【PRINCIPLE】
The HCV/HBsAg/HIV 1.2 Rapid Test (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of Hepatitis B surface antigen (HBsAg), antibodies to Hepatitis C Virus and HIV type 1 plus type 2 in whole blood, serum or plasma. The membrane is pre-coated with recombinant recombinant HCV antigen, HIV antigens and anti-HBsAg antibodies. During testing, the whole blood, serum or plasma specimen reacts with HIV antigen and/or Syphilis antigen and/or anti-HBsAg antibodies coated particles in the test. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with recombinant HIV antigen and/or Syphilis antigen and/or anti-HBsAg antibodies on the membrane and generates a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region,
indicating that the proper volume of specimen has been added and membrane wicking has occurred.
【REAGENTS】
The test cassette contains anti-HBsAg conjugated particles, anti-HBsAg coated on the membrane, recombinant HCV antigen conjugated particles, HCV antigen coated on the membrane and HIV 1 antigen plus HIV 2 antigen conjugated particles and HIV 1 antigen plus HIV 2 antigen coated on the membrane.
【PRECAUTIONS】
For professional in vitro diagnostic use only. Do not use after the expiration date.
Do not eat, drink or smoke in the area where the specimens or kits are handled.
Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
Humidity and temperature can adversely affect results.
【STORAGE AND STABILITY】
The kit can be stored at room temperature or refrigerated (2-30°C). The test cassette is stable through the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
【SPECIMEN COLLECTION AND PREPARATION】
The HCV/HBsAg/HIV 1.2 Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture) serum or plasma specimen.
To collect Fingerstick Whole Blood specimens:
Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet. Wipe away the first sign ofblood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
Add the Fingerstick Whole Blood specimen to the test by using a capillary tube:
Touch the end of the capillary tube to the blood until filled to approximately 25 μL. Avoid air bubbles.
Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense the whole blood to the specimen well of the test cassette.
Separate serum or plasma from blood as soon as possible to avoid hemolysis.
Use only clear non-hemolyzed specimens.
EDTA K2, Heparin sodium, Sodium citrate and Potassium oxalate can be used as the anticoagulant for collecting the specimen.
【MATERIALS】
Materials Provided
Test Cassettes
Droppers
Buffer
Package Insert
Materials Required But Not Provided
Specimen Collection Containers
Centrifuge
Timer
【DIRECTIONS FOR USE】
Allow test cassette, specimen 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 test cassette on a clean and level surface. Hold the dropper vertically and transfer 1 drop of specimen (approximately 25 μL) to the specimen well (S), then add 3 drops of buffer (approximately 120 μL) to the buffer well (B). Start the timer. See the illustration below.
3. Wait for the colored line(s) to appear. The test result should be read at 15 minutes. Do not interpret the result after 20 minutes.
