Standard - Immunology: Quality Control

(A) Serologic tests onunknown specimens shall be run concurrently with a positive control serumof known titer or controls of graded reactivity such as weak positive controls, plus a negative control in order to detect variations in reactivity levels. (B) Serum controls shall be used to detect the presence of non-specific reactions where applicable. (C) Controls for all test components (antigens, complement, erythrocyte indicator systems, etc.) shall be employed to insure reactivity and uniform dosage. Test results shall not be reported unless the predetermined reactivity pattern of the controls is obtained. (D) Each new lot of reagent or kits shall be tested concurrently with one of known acceptable reactivity with positive and negative serum samples before the new reagent or kit is placed in routine use. (E) Equipment, glassware, reagents, controls, and techniques for tests for syphilis shall conform to those recommended in the "Manual of Tests for Syphilis 1969" U.S. Public Health Service Publication No. 411, January 1969, as revised.