Table 2.

Characteristics of highest-scoring diagnostic devices stratified by test category.

Technology Classification			Antigen Tests	Molecular Tests
Test Classification			Near-POC	POC	Near-POC	Low-Complexity
Developer, Product Name			LumiraDx, LumiraDx	Pfizer, Lucira Health	Visby, COVID-19 Test	Biocartis, IdyllaTM
Overall Score *,†			73/110 (66%)	83/110 (75%)	78/110 (71%)	66/110 (60%)
Test summary	Platform: Specifications	Dimensions (cm)	21 × 9.7 × 7.3	19.1 × 8.0 × 5.2	13.8 × 6.7 × 4.4	30.5 × 19 × 50.5
		Weight (g)	1100	150	NR	18,600
		Power-supply	Integrated battery (20 tests)	AA batteries	Mains electricity (power adapter)	Standard electricity
		Connectivity	LumiraDx Connect cloud-based services; 2× USB ports; RFID reader; Bluetooth connectivity	None	None	USB port; Direct RJ45 Ethernet cable; Idylla Visualizer (PDF viewer); Idylla Explore (cloud)
		Max. operating temperature (°C)/humidity (%)	30/90	45/95	30/80	30/80
		Multi-use ‡	Yes	Yes	Yes	Yes
		Throughput capacity	1	1	1	8
		Costs (USD)	NR	Not applicable (instrument-free)	Not applicable (instrument-free)	NR
	COVID-19 Assay: Specifications	Sample type	NS, NPS	NS	NS, NPS	NPS
		Hands-on time (min)	1	1	<2	<2
		Running time (min)	12	30	30	90
		Shelf-life (months)	NR	18	NR	NR
		Costs per test (USD)	NR	>10/test	NR	NR
		LOD (copies/mL)	NR	900	100–1112	500
		Sensitivity (%)/Specificity (%)	82.7/96.9	93.1/100.0	100.0/98.7	100.0/100.0
POC features of equipment	Score		39/50 (78%)	36/50 (72%)	36/50 (72%)	32/50 (64%)
	Pros		Compact instrument size and weight Short test preparation and running time Battery-powered Fully integrated platform with cloud and EHR connectivity Fully integrated data analysis	Compact instrument size and weight Short test preparation and running time Battery-powered Instrument-free, fully integrated platform Fully integrated data analysis	Compact instrument size and weight Short test preparation and running time Instrument-free, fully integrated platform Fully integrated data analysis	High throughput capacity (n = 8) Fully integrated platform with multiple options for data export and connectivity Fully integrated data analysis Short test preparation time
	Cons		Low throughout capacity for an instrument-based assay (n = 1)	No connectivity	No connectivity Runs on mains electricity only	Large instrument size and heavy weight Runs on mains electricity only
POC features of consumables	Score		9/15 (60%)	14/15 (93%)	7/15 (47%)	7/15 (47%)
	Pros		High operating humidity	High operating temperature and humidity Long shelf-life	None	None
	Cons		Unknown shelf-life	None	Unknown shelf-life Low operating temperature	Unknown shelf-life Low operating temperature
Ease of use	Score		10/10 (100%)	10/10 (100%)	8/10 (80%)	6/10 (60%)
	Pros		Can be used by community or lay worker without technical skills No manual sample processing steps	Can be used by community or lay worker without technical skills, suitable for self-testing No manual sample processing steps	Can be used by community or lay worker without technical skills, suitable for self-testing Minimal sample processing steps	Can be used by healthcare workers with a minimum of training
	Cons		None	None	None	Sample processing steps require laboratory equipment (pipettes, vortex)
Performance	Score		5/15 (33%)	7/15 (47%)	11/15 (73%)	11/15 (73%)
	Pros		None	High study-reported specificity	High study-reported sensitivity and specificity	High clinical sensitivity and specificity
	Cons		No LoD reported Poor study-reported sensitivity Discrepancy between developer-reported and study-reported sensitivity data	High LoD Low study-reported sensitivity	High LoD	High LoD
Cost	Score		2/10 (20%)	6/10 (60%)	6/10 (60%)	2/10 (20%)
	Pros		None	No instrument costs	No instrument costs	None
	Cons		Costs not transparently reported	High consumable costs	Consumable costs not transparently reported	Costs not transparently reported
Platform versatility	Score		5/5 (100%)	5/5 (100%)	5/5 (100%)	5/5 (100%)
	Pros		Multi-use platform	Multi-use platform	Multi-use platform	Multi-use platform
	Cons		None	None	None	None

Abbreviations: POC = point-of-care; NR = Not Reported; NS = Nasal Swab; NPS = Nasopharyngeal Sample; LoD = Limit-of-Detection. Legend: * color coding: red = overall score/category score <33.3%; orange = overall score/category score <66.6%; green = overall score/category score ≥ 66.6%; ^† overall score: calculated by summing the seven category scores; category scores: calculated by aggregating the scores for each variable within the respective scoring category. Please refer to Table S4 for the detailed scoring methodology; ^‡ multi-use is defined as the ability to analyze multiple biomarkers from one sample on a single diagnostic device (e.g., respiratory panels).