|The HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of Hepatitis B Surface antigen (HBsAg) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Hepatitis B virus (HBV). Any reactive specimen with the HBsAg Rapid Test Kit must be confirmed with alternative testing methods and clinical findings.|
|Viral Hepatitis is a systematic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C (HCV). The complex antigen found on the surface of HBV is called HBsAg. The presence of 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 4 principal subtypes: adw. ayw. adr and ayr.. Because of antigenic heterogeneity of the determinant, there are 10 major stereotypes of Hepatitis B virus. The HBsAg Test Kit (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of HBsAg in whole blood, serum and plasma specimens. The test utilizes a combination of double monoclonal antibodies to selectively detect elevated levels of HBsAg in whole blood, serum and plasma.|
|Product name:||Hepatitis B (HBsAg) Rapid Screen Test|
|Type:||Pathological Analysis Equipment|
|Instrument classification:||Class II|
|Certificate||CE / ISO|
|Packing:||Pouch / Box|
|Format / Size:||Cassette / 3.0mm 4.0mm|
|Function:||Detect Hepatitis B Surface Antigen|
|Number of Targets Detected:||1|
|Method of Detection:||Chromatographic Immunoassay|
|Solid Support:||Lateral Flow|
|The HbsAg Rapid Screen Test is a lateral flow chromatographic immunoassay based on the principle of the double antibody-sandwich technique. The membrane is precoated with anti-HbsAg antibodies on the test line region of the test During testing. Hepatitis B Surface Antigen in the whole blood, serum or plasma specimen reacts with the particle coated with anti HBsAg antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HBsAg antibodies on the membrane and generate a colored line. The presence of this colored line in the test 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.|
1) Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and use it as soon as possible. Place the test strip on a clean and level surface.
2) For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen pad of the test strip, then start the timer. See illustration below.
3) For whole blood specimens: Hold the dropper vertically and transfer 1 drop of whole blood (approximately 35μl) to the specimen pad of the test strip, then add 2 drops of buffer (approximately 70μl) and start the timer.
4) Wait for the coloured line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
Important: In order to prevent an incorrect reading, do not read the test results after more than 8 minutes. If the test is read after 8 minutes, the intensity of the coloured lines may change or a new line may appear. To avoid confusion, discard the test device after interpreting the result
Hepatitis B (HbsAg) Rapid Screen Tests are supplied for both the professional Laboratory Environment and also Point of Care (POC) situations in remote settings. Components of each for of kit set are:
POC – HbsAg test kits are individually packed testing kits that incorporate the required components to perform a test in remote settings by medical professionals, first responders and trained personal. The POC – HbsAg test kit includes the following components:
- Test Cassette
- Buffer Solution
- Transfer Pipette
- Prep Pad
Laboratory Environments require the testing device and supporting reagents and therefore the test kit comprises of:
- 40 Individually packed test cassettes
- Buffer Solution
|Environments||Total Number of Tests||MOQ|
|Laboratory||40 Tests Per Box (Test Cassettes and Buffer Solution only)||5 Boxes|
|Point of Care||20 Complete Test Kits per box (Including Lancets, Alcohol Swabs and Pipettes)||5 Boxes|