High Light: | diagnostic tests for infection,infectious disease diagnostic tests |
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Application:
The HBV Combo Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb in serum or plasma.
Description:
Chronic hepatitis B is a serious, debilitating illness that can cause cirrhosis of the liver, liver cancer and death. Chronic hepatitis B is the main cause of liver cancer and the tenth leading cause of death worldwide, with 400,000,000 people infected with the virus. Every year, one million people worldwide are expected to die from this infection. Most people fight off the infection themselves, but approximately 5-10 percent of those infected with the virus become carriers, and an additional 5-10 percent of those infected each year will progress to chronic liver disease, cirrhosis and possibly liver cancer.
The HBVCombo Rapid Test Cassette (Serum/Plasma) is a rapid test to qualitatively detect the presence of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb in serum or plasma without the use of an instrument.
How to use?
Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
Place the test cassette on clean and level surface. Hold the dropper vertically and transfer 3 full drops of serum or plasma (approx.75ul) to each sample well of the test cassette respectively, then start the timer. Avoid trapping air bubbles in the specimen well. See the illustration below.
Wait for the red line to appear. The result should be read at 15 minutes.
Do not interpret the results after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
Warning: Do not interpret all 5 tests with the same criterion. Carefully follow the directions below.
HBsAg, HBsAb, HBeAg
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 HBsAg, HBsAb, HBeAg 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.
HBeAb, HBcAb
NEGATIVE:* 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) may vary. But it should be considered negative whenever there is even a faint pink line.
Positive: 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 |
IHB-355 | HBV Combo Rapid Test Cassette | S / P | Cassette | 25 T | See Insert | Non-CE |