Testsealabs HBsAb Rapid Test Kit (Whole Blood/Serum/Plasma)

Short Description:

Detection for: Antibody to Hepatitis B Surface Antigen in serum or plasma:
Specimen volume: 75 μL;
Reading time: 15 minutes
Sensitivity: 10mlU/ml of HBsAb;
Relative Sensitivity: >99.9%(97.5%CI*:98.7%-100%);
Relative Specificity: 98.4%(95% CI *:95.3%-99.7%);
Accuracy: 99.3%(95% CI *:97.9%-99.9%)


Product Detail

Product Tags

Intended Use

The One Step HBsAb Test is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface Antibody (HBsAb) in Whole Blood /Serum / Plasma.

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Summary

Hepatitis B is caused by a virus that affects the liver. Adults who get hepatitis B usually recover. However most infants infected at birth become chronic carriers i.e. They carry the virus for many years and can spread the infection to others.

Test Procedure

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Allow test cassette, serum or plasma specimen, and/or controls to equilibrate to room temperature (15-30℃) prior to testing
For Cassette:
1.Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the assay is performed immediately
after opening the foil pouch.
2.Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 μL) to the specimen well of test device and start the timer. Avoid trapping air bubbles in the specimen well. See illustration below
3.Wait for the colored line is appeared. The result should be read at 15minutes. Do not interpret the result after 20 minutes
For Strip:
1.Remove the test strip from the sealed foil pouch and use it within one hour. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2.With arrows pointing toward the serum or plasma specimens, immerse the test strip vertically in the serum or plasma for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test strip. See the illustration below
3. Place the test strip on a non-absorbent flat surface, start the timer and wait for the red line (s) to appear. The result should be read at 15 minutes
Note: A low HBsAb concentration might result in a weak line appearing in the test region (T) after an extended period of time, therefore. do not interpret
the result after 20 minutes.

Limitations

1. HBsAb Rapid Test Cassette/Strip (Serum/Plasma) is for in vitro diagnostic use c only. This test should be used for the detection of HBsAb in serum or plasma specimen.
2. HBsAb Rapid Test Cassette/Strip (Serum/Plasma) cannot detect less than 10m U/ml of HBsAb in specimens.
3.As with all diagnostic tests. all results must be considered with other clinical information available to the physician.

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