US · guidance
CMS SOM App. C, Tag D5455
§493.1256 Standard: Control procedures
(d)(3)(v) Each molecular amplification procedure, include two control materials
and, if reaction inhibition is a significant source of false negative results, a control
material capable of detecting the inhibition.
Interpretive Guidelines §493.1256(d)(3)(v)
The laboratory is also responsible for following any provided manufacturer’s instructions
concerning procedure limitations for detecting nucleic acid target amplification
sequences.
If the laboratory suspects the presence of interfering substances (inhibitors), the
laboratory is responsible for using a control material (in addition to positive and negative
control materials) capable of detecting interfering substances. Patient specimens may
contain substances (inhibitors) that interfere with the enzymatic reaction of a molecular
amplification procedure. These interfering substances could affect the assay’s sensitivity
causing a false negative result. Interfering substances may include, but are not limited to
components within the patient specimen or exogenous substances introduced during the
preanalytic and/or analytic phase of testing.
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
b51c321a2f8ac6b21cd92aea2db699ba26de68ea38ce8fecd84791fd0389b89e
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