eTable 1.

Available POC^∗ molecular diagnostic tests for COVID-19.^†

PRODUCT‡	TEST AT HOME	ACCESSIBILITY	MULTIANALYTE	METHOD	RESULTS REPRESENTATION§	SAMPLE TYPE¶	TARGET	PERFORMANCE EVIDENCE FOR SARS-CoV-2#	TIME TO RESULSTS
Cue COVID-19 Test for Home and OTC∗∗Use	Yes	OTC home testing, health care provider†† at POC	No	RT,‡‡ isothermal amplification	Qualitative, instrument read	Anterior nasal swab in adults (self-swabbing) or children ≥ 2 y of age (swabbed by an adult)	Nucleocapsid gene	LoD§§: 20 genome copies/sample wand PPA¶¶: 97.4% (95% CI, 86.5% to 99.5%) NPA##: 99.1% (95% CI, 96.9% to 99.8%)	~ 20 min
Visby Medical COVID-19 POC Test	No	Health care provider	No	RT-PCR∗∗∗	Qualitative, visual read	Nasopharyngeal, anterior nasal, or Midturbinate swabs collected by a health care provider or anterior nasal or mid-turbinate swabs self-collected (by people aged ≥ 18 y, under the supervision of a health care provider)	Nucleocapsid gene	LoD: 435 copies/swab PPA: 100.0% (95% CI, 89.0% to 100.0%) NPA: 95.3% (95% CI, 87.1% to 98.4%)	~ 30 min
Xpert Xpress SARS-CoV-2 Test	No	Health care provider	No	Real-time RT-PCR	Qualitative, instrument read	Nasopharyngeal, nasal, or mid-turbinate swab	Nucleocapsid gene, envelope protein gene	LoD: 5.4 x 103 RNA NAAT‡‡‡ detectable units/milliliter PPA: 97.8% (95% CI, 88.4% to 99.6%) NPA: 95.6% (95% CI, 85.2% to 98.8%)	30 min for positives and ~ 45 min for negatives
Accula SARS-Cov-2 Test	No	Health care provider	No	PCR and lateral flow	Qualitative, visual read	Clinician-collected nasal or nasal mid-turbinate swab samples or clinician-instructed self-collected (collected on site) nasal swab	Nucleocapsid gene	LoD: 200 copies/reaction. PPA: 95.8% (95% CI, 78.88% to 99.89%) NPA: 100% (95% CI, 86.77% to 100%)	~ 30 min
BioFire Respiratory Panel 2.1-EZ	No	Health care provider	Yes,16 viruses and 4 bacteria	Real-time, nested multiplexed PCR	Qualitative, instrument read	Nasopharyngeal swab	Spike protein gene and membrane protein gene	Overall, 97.1% sensitivity and 99.3% specificity (prospective specimens) 98.0% sensitivity and 100% specificity (archived specimens) 100% PPA and 100% NPA (contrived specimens)	~ 45 min
Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test	No	Health care provider	SARS-CoV-2, influenza A and influenza B virus	Multiplexed real-time RT-PCR	Qualitative, instrument read	Health care provider-collected nasopharyngeal and nasal swabs and self-collected nasal swabs (collected in a health care setting with instruction by a health care provider)	RdRp gene (ORF1ab) and nucleocapsid gene	LoD: 12 copies/mL PPA: 100% NPA: 100%	~ 20 min
Lucira COVID-19 All-in-One Test Kit	Yes	Prescription home testing, health care provider at POC	No	RT-loop mediated isothermal amplification	Qualitative, instrument read	Self-collected nasal swab in people aged ≥14 y and in people aged ≤ 13 y when the specimen is collected by a health care provider at the POC	2 non overlapping regions of the nucleocapsid gene	LoD: 900 copies/mL PPA: 94.1% (95%CI, 85.5% to 98.4% NPA: 98.0% (95%CI, 89.4% to 99.9%)	< 30 min
ID NOW COVID-19	No	Health care provider	No	RT, isothermal amplification	Qualitative, instrument read	Direct nasal, nasopharyngeal or throat swabs	RdRp	LoD: 125 genome equivalents/mL	≤ 13 min
Xpert Xpress SARS-CoV-2/Flu/RSV†††	No	Health care provider	SARS-CoV-2, influenza A and influenza B virus, RSV	Multiplexed real-time RT-PCR	Qualitative, instrument read	Nasopharyngeal or nasal swab	Envelope and N-nucleocapsid (N2)	LoD:131 copies/mL for COVID-19 PPA and NPA of 97.9% and 100.0% for SARS-CoV-2, respectively; 100.0% and 100.0% for influenza A, respectively; 100.0% and 99.0% for influenza B, respectively 100.0% and 100.0% for RSV, respectively	25 min for positive COVID-19 results and 36 min for all 4 pathogens
Cue COVID-19 Test	No	Health care provider	No	RT, isothermal amplification	Qualitative, instrument read	Direct nasal swabs	Nucleocapsid gene	LoD: 1,300 copies/mL PPA 100% NPA 92%	25 min

^∗POC: Point-of-care.

^†As of April 5, 2021. An up-to-date list of POC molecular diagnostic tests is available online at the US Food and Drug Administration’s “In Vitro Diagnostics EUAs: Molecular Diagnostic Tests for SARS-CoV-2.”⁷ Those tests that have W in the Authorized Setting column are authorized for POC use. The link for each product’s user instruction is provided in the Authorization Documents section.

^‡Products are listed according to the authorization date.

^§All of the mentioned products automate all aspects of nucleic acid testing, from nucleic acid extraction to results.

^¶Nasal and nasopharyngeal swabs are contraindicated in people who are susceptible to nosebleeds or have had recent facial or head injury or surgery.

^#SARS-CoV-2: Severe acute respiratory syndrome coronavirus 2.

^∗∗OTC: Over-the-counter.

^††A health care provider includes, but is not limited to, physicians, dentists, nurses, pharmacists, technologists, laboratory directors, epidemiologists, or any other practitioners or allied health care professionals. The Centers for Disease Control and Prevention provides an online guideline for the collecting and handling of clinical specimens for COVID-19 testing.³⁶

^‡‡RT: Reverse transcription.

^§§LoD: Limit of detection.

^¶¶PPA: Positive percentage agreement.

^##NPA: Negative percentage agreement.

^∗∗∗PCR: Polymerase chain reaction.

^†††NAAT: Nucleic acid amplification test.

^‡‡‡RSV: Respiratory syncytial virus.