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One-Step HBsAg Rapid Test ,WB/S/P,Cassette Strip
FOR THE QUALITATIVE ASSESSMENT OF HBsAg IN HUMAN SERUM, PLASMA OR WHOLE BLOOD
The HBsAg Rapid Test is a Chromatographic immunoassay (CIA) for direct qualitative detection of Hepatitis B type virus surface antigen (HBsAg) in human serum /plasma and whole blood.
The HBsAg RST is a chromatographic immunoassay (CIA) for the detection of surface antigens of Hepatitis B in human serum/plasma and whole blood. Specific antibody against HBsAg is pre-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with anotherr specific antibody. If HBsAg is present, a pink colored band will develop on the membrane in proportion to the amount of HBsAg presented in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence or absence of HBsAg.
REAGENTS AND MATERIALS PROVIDED
1.One sealed pouched cassette with desiccant and a disposable pipette..
2.Blood diluent in a dropper bottle. Store at 2-8°C.
3.One piece of operating instruction with 40 test pouches..
WARNING AND PRECAUTIONS
1. FOR IN VITRO DIAGNOSTIC USES ONLY
2.All patient samples should be treated as if capable of transmitting diseases.
3.Do not interchange reagents from different lots or use test kit beyond expiration date.
4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
The kits should be stored at temperature 4-30°C,( the sealed pouch) for the duration of the shelf life (24 months).
SAMPLE COLLECTION AND PREPARATION
Whole Blood ( Fingerstick Specimens)
Clean the area to be lanced with an alcohol swab.
1.Squeeze the end of the fingertip and pierce it with a sterile lancet.
2.Wipe away the first drop of blood with sterile gauze or cotton.
3.Use micropipette to obtain about 100ul fresh blood.
1.Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
2.Separate the plasma by centrifugation.
3.Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.
1.Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
2.Allow the blood to clot.
3.Separate the serum by centrifugation.
4.Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.
Serum or Plasma Sample
Add 70-100ul or 2-3 drops of serum or plasma into sample well. Observe the result in 5-20 minutes.
Whole Blood Sample
Add 1 drop of whole blood into sample well, after all blood is completely absorbed. Add 1 drop of whole blood diluent. Observe the result in 5-20 minutes.
INTERPRETATION OF RESULTS
Positive: In addition to the band in the control region (C), another pink band will appear in the test region (T). This indicates that the specimen contains HBsAg.
Negative: No band in the test region (T), only one pink band appears in the control region (C). This indicates that no HBsAg have been detected.
Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.
A total of 400 samples from susceptible subjects were tested by the HBsAg Rapid Test and by HBsAg ELISA kit with the test sensitivity at 1.0 ng/mL. The data showed the following.
Relative Sensitivity: 96%,
Relative Specificity: 100%,
overrall Agreement: 99.6%
Contact Person: Ms. Anna Lee