Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories
Section 180.400 - Standard - Immunology: Quality Control

Universal Citation: 105 MA Code of Regs 105.180

Current through Register 1531, September 27, 2024

(A) Serologic tests on unknown specimens shall be run concurrently with a positive control serum of 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.

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