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by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) created the concept of waived tests which are defined as tests that are so simple to perform, and produce accurate results so reliably, as to render the likelihood of erroneous results negligible; and which also pose no reasonable risk of harm to the patient even if the test is performed incorrectly. Thus, these tests are exempt from federal requirements for personnel qualification, training, and competency assessment; quality control (except as specified by the manufacturer), proficiency testing, quality assessment, and the need for routine inspection.

by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

Strep tests are used to determine if a person with a sore throat (pharyngitis) has strep throat, an infection of the throat and tonsils caused by the bacteria Streptococcus pyogenes, also called Group A Streptococcus (GAS), or if the sore throat is caused by a virus.  The majority of sore throats (70%-85%)1 are actually viral in nature, and will resolve without treatment within a few days.