Table 1.

Currently Available Food and Drug Administration-Approved Nucleic Acid Amplification Tests for Acute Pharyngitis

Manufacturer	Abbott	Cepheid	Roche	Cepheid	DiaSorin	Meridian Bioscience		QuidelOrtho
Instrument	ID NOW	Xpert Xpress	LIAT	Xpert/Xpert Infinity	Liaison MDX	Alethia	RevoGene	Solana		ABI 7500
Test name	ID NOW Strep A 2	Xpert Xpress Strep A	cobas Strep A	Xpert Xpress Strep A	Simplexa Group A Strep Direct	Alethia Group A Streptococcus	Revogene Strep A	Solana GAS	Solana Strep Complete	Lyra Direct Strep
Technology	iNAAT (NEAR)	qPCR	qPCR	qPCR	qPCR	iNAA (LAMP)	qPCR	iNAA (HDA)	iNAA (HDA)	qPCR
Assay run time, min	8–10	18–24	15	18–24	60	45–60	42–70	30	30	90
Number of samples per instrument	1	1–4	1	1–80	1–8	1–10	1–8	1–12	1–12	1–94
CLIA status	Waived	Waived	Waived	Moderate	Moderate	Moderate	Moderate	Moderate	Moderate	High
Throat swab testing, direct	Yes	No	No	No	No	No	No	No	No	No
Throat swab testing, transport mediaa	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Instrument size, inches, H × W × D	12 ×8 × 12	12 × 18 × 16	8 × 5 × 10	12 × 18 × 16 79 × 108 × 35	12 × 8 × 12	4 × 12 × 9	13 × 16 × 10	6 × 9 × 9	6 × 9 × 9	19 × 14 × 18
Instrument weight, lbs	10	25	8	25–2100	17	13	22	9	9	75
Limit of detection, CFU/mL
Group A Streptococcus	25–147	9–18	5–20	9–18	682–2350	400–430	333–1333	24 400–68 100	85 000	600–1500
Streptococcus dysgalactiae	…	…	…	…	…	…	…	…	710 000	16 000–18 000

Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; HDA, helicase dependent amplification; iNAAT, isothermal nucleic acid amplification; LAMP, loop-mediated isothermal amplification; NEAR, nicking enzyme amplification reaction; qPCR, real-time polymerase chain reaction.

^aSee package insert for specific assay transport media requirements.