INTERPRETATION OF RESULTS

POSITIVE: Two or Three bands will appear in the control and test areas, which indicate a positive result for HBsAg, respectively. The lines in the TEST (T) area may look different from the line in the CONTROL (C) area. Intensities of the Test and Control Lines may vary. Test Result with visible lines in both TEST (T) and CONTROL (C) areas, regardless of intensity, is considered REACTIVE. A Reactive Test Result means that HBsAg has been detected in the specimen. The Test Result is interpreted as Preliminary POSITIVE for HBsAg.

NEGATIVE: One pink/purple line in the CONTROL (C) area, with no line in the TEST (T) area indicates a NONREACTIVE Test Result. A NONREACTIVE Test Result means that HBsAg were not detected in the specimen or that the levels are below the detection limits of the test. The Test Result is interpreted as NEGATIVE for HBsAg.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. A pink/purple line should always appear in the CONTROL (C) area, whether or not a line appears in the TEST (T) area. If there is no distinct pink/purple line visible in the CONTROL (C) area (see diagram), then the test is INVALID. An INVALID test cannot be interpreted. It is recommended that the INVALID test be repeated with a new device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

NOTE: The intensity of the red color in the test area will vary depending on the concentration of HBsAg present in the specimen. However, neither the quantitative value nor the rate of increase in HBsAg can be determined by this qualitative test.