Table 3.

Published sensitivity and specificity of RSV tests reviewed under CLIA guidance only.

Test	Manufacturer	Technology	Analytical time, min	Sample type	Age of intended patient population, years	Sensitivity range,a % (95% CI)	Specificity range,b % (95% CI)	Studies, n	References
Waived
BD Veritor System RSV	Becton, Dickinson and Company	Antigen	10	Nasopharyngeal swab	<6 years	67.5 (56.1–77.6) to 97.6 (NRc)	96.8 (91.1–99.3) to 100 (97.0–100)	7	(25–31)
Alere Binax NOW RSV	Abbott	Antigen	15	Nasopharyngeal swab and nasopharyngeal aspirate/wash	<5 years	41.2 (NR) to 90 (NR)	93.2 (92.8–93.6) to 100.0 (97–100)	13	(32–44)
cobas Liat Influenza A/B & RSV Assay	Roche Diagnostics	Molecular	20	Nasopharyngeal swab	Not specified	94.2 (87.9–97.9) to 100.0 (96.07–100.0)	94.29 (86.01–98.42) to 100 (97.7–100)	7	(15, 45–50)
ID NOW RSVd	Abbott	Molecular	13	Nasopharyngeal swab	<18 years and ≥60 years	93 (89–96) to 100 (93–100)	96 (93–98) to 98.0 (95.8–99.1)	4	(15, 51–53)
QuickVue RSV	Quidel	Antigen	15	Nasopharyngeal swab and nasopharyngeal aspirate and/or nasal wash	≤18 years	25.7 (NR) to 90.1 (86.8–93.4)	98.5 (NR) to 99.5 (92–99)	4	(30, 54–56)
Sofia RSV FIAe	Quidel	Antigen	15	Nasopharyngeal swab and nasopharyngeal aspirate/wash	<19 years	74.8 (68.0–80.9) to 100 (82–100)	86.8 (85.7–87.4) to 100 (95.2–100)	8	(29, 30, 33, 41, 43, 57–59)
Xpert Xpress Flu/RSV	Cepheid	Molecular	30	Nasopharyngeal swab and/or nasal swab	Not specified	66.7 (24.1–94.0) to 98.1 (88.8–99.9)	98.1 (96.6–99.0) to 100 (99.7–100)	5	(45, 60–63)
Moderate complexity
3M Rapid Detection RSV Test	3M Health Care	Antigen	15	Nasopharyngeal swab and nasopharyngeal aspirate and/or nasal wash	≤21 years	60.0 (38.5–81.5) to 87.3 (83.8–90.1)	95.6 (93.8–96.9) to 99.6 (98.7–100)	2	(64, 65)
Aries Flu A/B & RSV Assay	Luminex Corporation	Molecular	120	Nasopharyngeal swab	Not specified	88.6 (58.3–97.6) to 97.1 (94.4–98.7)	98.4 (97.7–98.9) to 100.0 (98.8–100)	4	(44, 45, 47, 66)
BioFire FilmArray Respiratory 2.1 Panel	bioMérieux	Molecular	45	Nasopharyngeal swab	Not specified	62.5 (24.5–91.5) to 99.4 (96.9–99.9)	98.3 (97.5–98.9) to 100 (97.2–100)	4	(45, 67–69)
Directigen EZ RSV	Becton, Dickinson and Company	Antigen	15	Not specified	<20 years	59 (NR) to 90 (NR)	89.5 (NR) to 99.5 (97.0–100)	6	(30, 32, 42, 70–72)
ePlex Respiratory Pathogen Panel	GenMark Diagnostics	Molecular	120	Nasopharyngeal swab	Not specified	89.6 (80.0–94.8) to 100 (92.6–100)	98.9 (94.2–99.8) to 100 (99.8–100)	2	(73, 74)
High complexity
Panther Fusion Flu A/B/RSV Assay	Hologic, Inc.	Molecular	Not reported	Nasopharyngeal swab	Not specified	88.4 (81.1–93.1) to 100 (NR)	98.7 (97.0–99.6) to 100 (99.7–100)	6	(45, 47, 74–77)
Simplexa Flu A/B & RSV	Diasorin Molecular	Molecular	60	Nasopharyngeal swab	Not specified	73.3 (44.8–91.0) to 87.0 (74.5–94.2)	99.4 (96.3–99.9) to 100 (98.9–100)	3	(45, 47, 78)

^aSensitivity and specificity ranges are not reported for RSV tests with <3 supporting subrecords.

^bSpecificity ranges are not reported for RSV tests with <3 supporting subrecords.

^cNot reported.

^dThe ID NOW RSV was formerly known as the Alere i RSV.

^eFluorescence immunoassay.