|Storage:||2-30℃||Shelf Time:||24 Months|
rapid test kit,
diagnostic tests for infection
The HBsAb Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Antibody to Hepatitis B Surface Antigen in whole blood, serum or plasma.
Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis Avirus, Hepatitis B virus (HBV) or Hepatitis C virus. The complex antigen found on the surface of HBV is called HBsAg. The presence of HBsAg in whole blood, serum or plasma is an indication ofan active Hepatitis B infection, either acute or chronic. The antibody to HBsAg, HBsAb, may not become detectable for 3-6months after acute infection. It is associated with resolution of the illness. This antibody is recognized as the marker of immunity to HBV. As a result, vaccination against HBV was introduced to control the morbidity and mortality associated with the virus. As part of the World Health Organization (W.H.O) program for the control of Hepatitis B, many people, especially new born infants, receive vaccination. The minimum standard titer of HBsAb is 10 mIU/mL for protective immunity to HBV. Unfortunately, approximately 5-15% of healthy immune competent individuals either does not exhibit an antibody response to the existing recombinant vaccination or respondpoorly. 2 The HBsAb Rapid Test Dipstick (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of HBsAb in whole blood, serum or plasma specimen. The test utilizes a double antigen sandwich system to detect as low as 10mIU/ml of HBsAb in whole blood, serum or plasma.
【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test Dipstick from the sealed pouch and use it within one hour.
2. Place the test cards on a clean and level desk, then peel off the strip label of the test cards, stick the test dipstick onto it as soon as possible before testing.
For Serum or Plasma specimen:
· Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 μl) to the specimen area of test Dipstick and start the timer. See illustration below.
For Venipuncture Whole Bloodspecimen:
· Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 μl) to the specimen area, then add 1 drop of buffer (approximately 40 mL), and start the timer. See illustration below.
For Fingerstick Whole Bloodspecimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 75 μl of fingerstick whole blood specimen to the specimen area of test Dipstick, then add 1 drop of buffer (approximately 40 μl) and start the timer. See illustration below.
·To use hanging drops: Allow 3 hanging drops of fingerstick whole blood specimen (approximately 75 μl) to fall into the specimen area of test Dipstick, then add 1 drop of buffer (approximately 40 μl) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of HBsAb present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
|Cat. No.||Product Description||Specimen||Format||Kit Size||Cut-Off||Status|
|IHBSB-402||HBsAb Rapid Test Cassette||WB/S/P||Cassette||40 T||See Insert||Non-CE|