title: Quality control for qualitative assays: quantitative QC procedure designed to assure analytical quality required for an ELISA of hepatitis B surface antigen.
abstract: An assay for hepatitis B surface antigen (HBsAg) should reliably detect 0.2 microgram/L, the lowest reported concentration in an asymptomatic blood donor. The difference between this concentration and the assay cutoff defines the analytical quality requirement in a total error format. The design of a statistical QC procedure is critically dependent on the precision of the assay. The precision of a developmental ELISA of HBsAg under study ranged from 17.5% to 9.6% for controls containing 0.07 to 1.50 micrograms/L, respectively. Use of one positive control with the 1(3s), QC rule provided an 85% chance of detecting a critical loss of assay sensitivity; use of two positive controls increased the chance of detecting critical loss of assay sensitivity to nearly 100%. These rules are based on the precision of this developmental assay, and must be developed individually for other assays. The development of the proposed QC procedures illustrates how quantitative QC can be provided for qualitative assays.
authors.affiliation: Ortho Diagnostic Systems, Raritan, NJ 08869, USA. ggreen@odsus.jnj.com
authors.forename: G A
authors.initials: GA
authors.lastname: Green
authors.forename: R N
authors.initials: RN
authors.lastname: Carey
authors.forename: J O
authors.initials: JO
authors.lastname: Westgard
authors.forename: T
authors.initials: T
authors.lastname: Carten
authors.forename: L
authors.initials: L
authors.lastname: Shablesky
authors.forename: D
authors.initials: D
authors.lastname: Achord
authors.forename: E
authors.initials: E
authors.lastname: Page
authors.forename: A V
authors.initials: AV
authors.lastname: Le
mesh_terms: D001782:Blood Donors; D003198:Computer Simulation; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic