Table 1.

Nonexhaustive list of commercially available US Food and Drug Administration– and Conformité Européenne–approved point-of-care tests in infectious diseases classified by syndrome or disease of interest

Syndrome or disease	Specific test, duplex or panel	Targeted pathogens	Technique	Clinical specimen types	Trade names of some available assays	Test performance characteristicsa			Reference
						Sensitivity	Specificity	TAT (minutes)
Upper respiratory tract infections	Specific	Group A Streptococcus	LFIA	Pharyngeal swabs	Sofia StrepA FIA	84.9%	96.8%	5	[4]
	Specific	Group A Streptococcus	LFIA	Pharyngeal swabs	TestPack Strep A	75.3%	98.1%	5	[4]
	Specific	Group A Streptococcus	rPCR	Pharyngeal swabs	AmpliVue GAS Assay	98.3%	93.2%	60	[5]
	Specific	Group A Streptococcus	rPCR	Pharyngeal swabs	cobas Liat Strep A Assay	95.5%	99.3%	15	[6]
	Specific	Group A Streptococcus	rPCR	Pharyngeal swabs	Xpert Xpress Strep A	100%	79.3%	25	[7]
Lower respiratory tract infections	Specific	Streptococcus pneumoniae	LFIA	Urine samples	Sofia S. pneumoniae FIA	66%	100%	10	[8]
	Specific	S. pneumoniae	LFIA	Urine samples	BinaxNow Streptococcus pneumoniae Antigen Card	62%	98%	15	[8]
	Specific	Legionella pneumophila	LFIA	Urine samples	BinaxNOW Legionella Urinary Antigen Card	79.7%	97.1%	15	[9]
	Specific	Mycoplasma pneumoniae	LAMP	Throat swabs	Illumigene Mycoplasma Direct DNA amplification assay	87%	97.9%	60	[10]
	Specific	Influenza A and B	rRT-PCR	NP swabs	cobas Influenza A/B assay	IA: 97.5% IB: 96.9%	IA: 97.9% IB: 97.9%	20	[11]
	Specific	Influenza A and B	rRT-PCR	NP swabs	ID NOW INFLUENZA A & B (formerly Alere i. Influenza A & B)	NA	NA	15	[12]
	Specific	Influenza A and B	LFIA	Nasal swabs, NP swabs, NP aspirate/wash	Sofia influenza A + B FIA	IA: 82.2% IB: 77.8%	IA: 100% IB: 100%	15	[13]
	Specific	RSV	rRT-PCR	NP swabs/aspirate	ID NOW RSV (formerly Alere I RSV)	100%	97%	15	[14]
	Panel	Influenza A/B, RSV	rRT-PCR	NP swabs	cobas Influenza A/B & RSV	NA	NA	20	[15]
	Panel	Influenza A/B, RSV	rRT-PCR	Nasal wash fluid samples/aspirates and NP swabs	Xpert Flu/RSV XC	NA	NA	40	[16]
	Panel	Human adenovirus, human metapneumovirus, rhinovirus/enterovirus, influenza A/B, parainfluenza, RSV, Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae	r(RT-)PCR	NP swabs	BioFire FilmArray Respiratory Panel	NA	NA	65	[17,18]
	Panel	Human adenovirus, coronavirus, human metapneumovirus, rhinovirus/enterovirus, influenza A/B, parainfluenza, RSV, MERS-Cov, Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Bordetella parapertussis	r(RT-)PCR	NP swabs	BioFire FilmArray Respiratory Pane12 plus (RP2plus)	NA M. pneumoniae: 95.8%	NA M. pneumoniae: 99.7%	45	[19]
	Panel	Human adenovirus, coronavirus, human metapneumovirus, human rhinovirus/enterovirus, influenza A/B, parainfluenza, RSV-A/-B, Chlamydia pneumoniae, Mycoplasma pneumoniae	r(RT-)PCR	NP swabs	ePlex Respiratory Pathogen (RP) Panel	NA	NA	90	[20]
Gastro-intestinal infections	Specific	Clostridium difficile	rPCR	Stool samples	Xpert C. difficile BT	21.5%	100%	47	[21,22]
	Specific	C. difficile	rPCR	Stool samples	cobas Cdiff test	92.9%	98.7%	20	[23]
	Specific	C. difficile	EIA	Stool samples	Xpect C. difficile Toxin A/B Test	48%	84%	20	[24]
	Specific	C. difficile	EIA	Stool samples	VIDAS C. difficile GDH and VIDAS C. difficile Toxin A & B	80–89.8%	96.7–97.3%	50	[25]
	Panel	Campylobacter (jejuni, coli and upsaliensis), Clostridium difficile (toxin A/B), Plesiomonas shigelloides, Salmonella, Yersinia enterocolitica Vibrio (parahaemolyticus, vulnificus, cholerae), Escherichia coli O157, enteroaggregative E. coli (EAEC), enteropathogenic E. coli (EPEC), enterotoxigenic E. coli (ETEC) lt/st, Shiga-like toxin-producing E. coli (STEC) stx1/stx2E. coli O157, Shigella/enteroinvasive E. coli (EIEC), adenovirus F 40/41, astrovirus, norovirus GI/GII, rotavirus A, sapovirus (I,II, IV, and V), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia	rPCR	Stool samples	BioFire FilmArray GI Panel	100% for 12/22 targets ≥94.5% for an additional 7/22 targets	≥97.1% for all panel targets	60	[26]
Central nervous system infections	Duplex	Cryptococcus neoformans, Cryptococcus gattii	LFIA	Serum, CSF samples	CrAg LFA	100%	99.8%	20	[27]
	Specific	S. pneumoniae	LFIA	CSF samples	BinaxNow Streptococcus pneumoniae Antigen Card	95.4–100%	100%	15	[28]
	Specific	Enterovirus	rRT-PCR	CSF samples	NucliSENS EasyQ Enterovirus v1.1	NA	NA	120	[29]
	Panel	E. coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, S. pneumoniae, Streptococcus agalactiae, enterovirus, HSV-1/2, VZV, CMV, HHV-6, human parechovirus, C. neoformans/C. gattii	r(RT-)PCR	CSF samples	BioFire FilmArray Meningitis/Encephalitis (ME) Panel	E. coli K1: 100% Haemophilus influenzae: 100% (n = 1) L. monocytogenes: NA N. meningitidis: NA S. agalactiae: 0% (n = 1) S. pneumoniae: 100%	E. coli K1: 99.9% H. influenzae: 99.9% L. monocytogenes: 100% N. meningitidis: 100% S. agalactiae: 99.9% S. pneumoniae: 99.2%	65	[30]
Fever in the returning traveller	Specific	Plasmodium spp.	LFIA	Whole blood samples	BinaxNOW Malaria	All patients 84.2% Patients without antimalarial therapy: 92.9%	99.8%	15	[31]
	Specific	Plasmodium spp.	LAMP	Whole blood samples	Illumigene Malaria DNA amplification assay	98.1%	97.6%	10	[32]
	Specific	Dengue virus	EIA	Plasma, serum samples	NS1 Ag detectionb				[33]
					•Dengue NS2 Ag Strip	52%	77%	30
					•OnSite Dengue Ag Rapid Test	40%	76%	30
					•Dengue Early Rapid Test	60%	75%	20
					•SD Bioline Dengue Duo	59%	78%	20
					IgM detection
					•Dengue IgG/IgM Rapid Test Device	63%	91%	20
					•OnSite Dengue IgG/IgM Combo	46%	86%	30
					•SD Bioline Dengue Duo	89%	80%	20
Sexually transmitted infections	Duplex	Chlamydia trachomatis, Neisseria gonorrhoeae	rPCR	Vaginal/endocervical and urine samples	Xpert CT/NG	C. trachomatis in female endocervical, vaginal, urine samples: 97.4%, 98.7%, 97.6% C. trachomatis in male urine samples: 97.5% N. gonorrhoeae in female subjects in endocervical, vaginal, urine samples: 100%, 100%, 95.6% N. gonorrhoeae in male urine samples: 98%	C. trachomatis in female and male samples: ≥99.4% N. gonorrhoeae in female and male samples: ≥99.8%	90	[34]
	Duplex	C. trachomatis, N. gonorrhoeae	rPCR	Endocervical and ureteral samples	Gen-Probe PACE2C system for Chlamydia trachomatis and Neisseria gonorrhea	96.3%	98.8%	95	[35]
	Specific	Treponema pallidum	LFIA	Serum, plasma, whole blood samples	DETERMINE SYPHILIS TP	95.6–98.4%	97.3–95.7%	15	[36]
	Specific	T. pallidum	LFIA	Serum, plasma, whole blood samples	VisiTect Syphilis	57%	99%	30	[37]
	Specific	T. pallidum	LFIA	Serum, plasma, whole blood samples	Syphicheck-WB	67.4%	98.4%	15	[38]
	Specific	HIV		Blood samples	Antibody detection	(sensitivity for HIV-1 M Ab)			[39]
					•EXACTO TEST HIV Self-test	100%	98.5%	20
					•INSTI HIV	100%	100%	30
					•Stat-View HIV-1/2	100%	100%	Immediately
					•Vikia HIV-1/2	100%	100%	20
					Antibody/antigen detection	99.5%	99.5%	30
					•Determine HIV-1/2 Ag/Ab Combo	100%	Antigen p24: 99.5% Antibodies: 100%	40

CMV, cytomegalovirus; CSF, cerebrospinal fluid; EIA, enzyme immunoassay; FIA, fluorescent immunoassay; HSV, herpes simplex virus; LAMP, loop-mediated isothermal amplification; LFIA, lateral flow immunoassay; NA, not applicable; NP, nasopharyngeal; r(RT-)PCR, real-time (reverse transcription-)polymerase chain reaction; RSV, respiratory syncytial virus; SSTI, skin and soft tissue infection; TAT, turnaround time; VZV, varicella zoster virus.

^aThe performance characteristics of the assays are described as sensitivity and specificity according to published clinical validation studies when available. In the absence of test comparison against a reference standard assay, the reported positive and negative percentage agreement in the clinical studies reviewed were not reported to avoid misinterpretation.

^bSensitivity has been extracted from the ‘acute infection’ population and specificity has been extracted from the ‘naive individuals’ population described in the corresponding reference.