105 CMR, § 180.400 - Standard - Immunology: Quality Control
(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.
Notes
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