TABLE 1.

Methods for CLIA-waived group A Streptococcus testing

Laboratory test	% sensitivity	% specificity	Method	Turnaround time (min)	CLIA complexity	Secondary confirmation recommended upon negative results
Latex agglutination	53–92a	85–96b	Visual agglutinationc	<10	Waived	Yes
Lateral flow immunoassay	85–87d	92–96d	Visual identification of antigen capturec	<10	Waived	Yes
Optical immunoassay	71–95e	69–96e	Optical density change with antigen capturec	<8	Waived	Yes
Roche cobas strep A assay	95.0f	94.2f	PCR amplification	<15	Waived	No
Abbott strep A and strep A2 assays	98.5f	93.4f	Isothermal DNA amplification	2–6	Waived	No
Xpert Xpress strep A assay	99.4f	94.1f	RT-PCR amplificationg	18–24	Waived/moderate	No

^aSee references 12 to 14.

^bSee references 13 and 14.

^cOptical readers are available for interpretation for various vendors.

^dSee references 14 and 15.

^eSee reference 14.

^fManufacturers’ reported sensitivity and specificity data.

^gRT-PCR, real-time PCR.