Table 1.
Landscape of Food and Drug Administration–Cleared Diagnostic Tests for Acute Respiratory Tract Infection
| Targetsa | Approved Specimen Types | Timeb | Costc |
|---|---|---|---|
| CLIA-waived assays | |||
| Influenza A/B only | NS direct, NPS direct, NP, NPS | 15–30 minutes | $$–$$$ |
| RSV only | NPS direct, NS, NPS | 15 minutes | $$$ |
| Flu A/B plus RSV | NS, NPS | 20–30 minutes | $$–$$$ |
| Multiple viruses plus atypical bacteria | NPS | 60 minutes | $$$$ |
| Moderate- to high-complexity assays | |||
| Influenza A/B only | NS, NPS | 0.5–2 hours | $$ |
| PIV only | NPS | 3.5 hours | $$ |
| Flu A/B plus RSV | NS, NPS, NPA, NW | 0.5–3.5 hours | $$–$$$$ |
| RSV plus hMPV | NS, NPS | 0.75 hours | $S |
| AdV, hMPV plus RV | NPS | 3.5 hours | $$ |
| Multiple viruses plus atypical bacteria | NPS | 0.75–5 hours | $$$$ |
| Multiple bacteria with resistance | ETA | 4–5 hours | $$$$$ |
| Multiple viruses and bacteria with resistance | S, ETA, BAL | 60 hours | $$$$$ |
The FDA’s website contains a comprehensive list of cleared molecular microbial tests: https://www.fda.gov/medical-devices/vitro-diagnostics/nucleic-acid-based-tests. Definitions: Assays vary in the type of specimens approved by the FDA and in the number of organisms they can detect: “Direct” testing uses a swab, without transport media; “Atypical” bacteria may include Bordetella pertussis, Bordetella parapertussis Chlamydia pneumoniae and/or Mycoplasma pneumoniae; “Multiple viruses” may include AdV, coronaviruses, hMPV, influenza A/B, PIV, RSV, and RV; “Multiple bacteria” may include Acinetobacter calcoaceticus-baumannii complex, Citrobacter freundii, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae group, K. oxytoca group, K. variicola group, Legionella pneumophila, Moraxella catarrhalis, Morganella morganii, Proteus species, Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Stenotrophomonas maltophilia, Streptococcus agalactiae, S. pneumoniae, and S. pyogenes; antimicrobial “resistance” genes may include tem, mecA/C, MREJ, CTX-M, KPC, NDM, Oxa-48-like, Oxa-23, Oxa-24, Oxa-58, IMP, and VIM.
Abbreviations: AdV, adenoviruses; BAL, bronchoalveolar lavage; CLIA, Clinical Laboratory Improvement Amendments; ETA, endotracheal aspirate; FDA, Food and Drug Administration; hMPV, human metapneumovirus; NPA, nasopharyngeal aspirate; NPS, nasopharyngeal swab; NS, nasal swab; NW, nasal wash; PIV, parainfluenza viruses; RSV, respiratory syncytial virus; RV, rhinovirus; S, induced/expectorated sputum.
a The FDA categorizes diagnostic tests by their complexity. Nonlaboratory staff can perform waived tests because they are deemed simple to use and the FDA has determined there is little chance the test will provide wrong information or cause harm if done incorrectly. Moderate- to high-complexity tests must be performed in qualified laboratories or sites that meet certain regulatory requirements and quality standards.
bAssay run time is displayed in minutes or hours. It is important to differentiate run time from total turnaround time to results, which includes the time from specimen collection to issuance of results by the laboratory.
cApproximate cost (US dollars) is derived from the quoted list price for reagents plus controls per test reaction. Instrument costs, depreciation, and labor are not included. $ = 1–25, $$ = 26–50, $$$ = 51–100, $$$$ = 101–150, $$$$$ =151–200.