a. Hepatitis A IgG antibody (HAVAB) or approved equivalency (See Section 3.12 of the ITB). Each HAVAB Diagnostic Test Kit must: (1) Include Reagent tests and all Diagnostic Test Kit components (including controls and calibrators) as specified in the Package Insert; (2) Be FDA approved on a common automated, random-access laboratorybased analyzer; (3) Be independent from the other Diagnostic Test Kits; (4) Perform together with the other Diagnostic Test Kits and the common analyzer as a complete and compatible system; (5) Be FDA approved for serum specimens. The specimen stability must include at least 1 day at room temperature, 6 days at 2 to 8 degrees Celsius, and three freeze/thaw cycles; (6) Include a Package Insert. Have FDA approved statements in the Package Insert concerning acceptable sensitivity, specificity, or other measures of the Diagnostic Test Kits’ performance. Have clearly specify acceptable specimen types in the Package Insert’s Intended Use Statement; and (7) Have a minimum shelf-life of 90 days from the date of receipt at the respective Department BPHL locations. b. Hepatitis B surface antigen (HBSAG) including HBSAG confirmatory. Each HBSAG Diagnostic Test Kit must: (1) Include Reagent tests and all Diagnostic Test Kit components (including controls and calibrators) as specified in the Package Insert; (2) Be FDA approved on a common automated, random-access laboratorybased analyzer; (3) Be independent from the other Diagnostic Test Kits; (4) Perform together with the other Diagnostic Test Kits and the common analyzer as a complete and compatible system; (5) Be FDA approved for serum specimens. The specimen stability must include at least 1 day at room temperature, 6 days at 2 to 8 degrees Celsius, and three freeze/thaw cycles;
