INTENDED USE:
One Step Multi-HBV Test Device is a rapid, qualitative, immunoassay for the determination of HBV Markers (HBsAg, HBsAb, HBeAg,HBeAb, and HBcAb) in human serum or plasma in a convenient one step test format. Both the testing and results are intended to be used by medical and forensic professionals only. The test should not be used without appropriate supervision.
TEST PROCEDURE:

1. Bring the pouched test device to room temperature (15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Add 60µl (2 drops) of serum or plasma to each sample well and simultaneously start timing.
4. Add 40µl (1 drop) of buffer if the specimens is whole blood.
5. Read test results after 20 minutes. Do not read test results after 30 minutes.

INTERPRETATION OF RESULTS:
(1) HBsAg, HBsAb, HBeAg

Positive: Two colored lines appear in the result window, one in the test region (T) and another one in the control region(C). The result is positive no matter the test line is weaker or stronger than the control line.
Negative: Only one colored line appears in the control region(C).
Invalid: If no line appears in the control region, the test result is invalid regardless of the presence or absence of the test line.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.
(2) HBeAb, HBcAb


Positive：Only one line appears in the control region(C).
Weak positive: One colored line appears in the control region (C) and a weaker colored line appears in the test region (T).
Negative: Two colored lines appear in the result window, one in the control region (C) and another one in the test region (T).
Invalid: If no line appears in the control region, the test result is invalid regardless of the presence or absence of the test line.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.
SPECIFICATION:

Description	Specimen	Format	Catalog No.	Sensitivity	Package Size	Strip Width	Certificate
(HBV)Hepatitis B Virus Test Panel(5 in 1)	Serum/Plasma	Multi-panel	B16-20	HBsAg:2ng/mL HBsAb:30mlU/mL HBeAg:2NCU/mL HBeAb:2NCU/mL HBcAb:2NCU/mL	15 Tests	4.0 mm	——
	Whole Blood		B16-21		15 Tests	4.0 mm