• The FirstVue™ HBsAg Test Device is for in vitro use only. The test should be used for the detection of antibodies specific to HBsAg in the specimen.

• The FirstVue™ HBsAg Test Device will only indicate the presence of antibodies to HBsAg in the specimen and should not be used as the sole criteria for the diagnosis of HBSAG infection.

• For confirmation, further analysis of the specimens should be performed, such as EIA and/or western blot analysis. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

• If the test result is negative and clinical symptoms persist, additional follow-up tests using other clinical methods are recommended. A negative result at any time does not preclude the possible presence of Hepatitis B Virus.

• The FirstVue™ HBsAg Serum/Plasma/Whole Blood Cassette cannot detect less than 1 ng/mL of HBsAg in specimens. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of Hepatitis B infection.