RetiredCapital BluecrossPolicy AHS - G2174
Coronavirus Testing in the Outpatient Setting
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Defines Capital Bluecross coverage and reimbursement rules for coronavirus (including SARS-CoV-2, SARS, MERS) testing performed for medical decision-making in the outpatient setting; excludes work/school/state/federally mandated testing and addresses which tests meet or do not meet coverage criteria.
Policy Summary
PayerCapital Bluecross
PolicyCoronavirus Testing in the Outpatient Setting
Policy CodePolicy AHS - G2174
Change TypeRetirement (no material revision noted)
Effective DateSep 18, 2015
Next Review Date
Key ActionFollow specimen type and collection instructions per FDA labeling/EUA; NAATs are generally preferred for symptomatic individuals and negative antigen results should be confirmed with an FDA‑authorized molecular assay when clinically indicated.
SourceLink
POLICY UPDATE CHANGES
No material clinical or coverage changes in this revision.
7types of coverage determinations listed
1code-per-DOS reimbursement rule
0states restricted by policy
Specimen collectionincidental, not reimbursed
12IDSA NAAT recommendations summarized
Coverage Criteria for Outpatient Coronavirus Testing
Outpatient coronavirus testing coverage criteria
Covered when ALL of the following apply: testing is for medical decision‑making in the outpatient setting and the specific clinical scenarios listed below.
Outpatient testing for medical decision making (policy excludes work/school/state/federally mandated testing).
Covered nucleic acid testing (MEETS coverage)
- Targeted NAAT (e.g., RT-PCR, rapid molecular tests) for individuals displaying signs or symptoms of possible COVID‑19.
- Targeted NAAT for asymptomatic individuals with known exposure to COVID‑19.
- Targeted NAAT for individuals with signs/symptoms of SARS and travel to endemic areas or exposure to persons with SARS.
- Targeted NAAT for individuals with signs/symptoms of MERS and travel to endemic areas or exposure to persons with MERS.
Covered for specific syndromic or post‑infectious indications
- Nucleic acid amplification testing and host antibody serology testing to support diagnosis of MIS‑C, MIS‑A, or post‑acute sequelae of SARS‑CoV‑2 infection (PASC).
- Antigen‑detecting diagnostic tests for symptomatic individuals when performed once every 48 hours.
Billing constraints: only one code per date of service will be reimbursed (do not submit both HCPCS and AMA codes for same procedure same DOS); specimen collection codes are incidental and not separately reimbursed.
Coverage is subject to the member's benefit plan and applicable federal/state regulations.
Testing interpretation and operational criteria
Testing usage and interpretation guidance — apply these operational considerations when ordering and interpreting tests:
RT‑PCR (NAAT) is the primary method to diagnose acute SARS‑CoV‑2 infection; it requires appropriate specimen type and timing relative to symptom onset; negative RT‑PCR does not exclude infection and must be combined with clinical context.
Host antibody (serologic) testing should NOT be used to diagnose acute infection; timing of seroconversion limits early sensitivity and positive results do not necessarily indicate protective immunity.
Specimen and collection site matter: less invasive specimens (e.g., anterior nares) may be acceptable in some contexts but can yield more false negatives versus NP or combined specimens; follow assay‑specific FDA labeling/EUA or validated LDT procedures.
Point‑of‑care and rapid nucleic acid-based tests can reduce time to result and may improve operational outcomes but performance and validation vary by method and setting; adhere to manufacturer/system requirements.
Consider pre‑procedural testing yield and resource impact: routine asymptomatic PCR screening has low positivity in some series and testing strategies should weigh benefits, costs, and scheduling implications.
Coverage and interpretation guidance
Performance‑based guidance derived from test characteristics and study findings:
Antibody testing: IgG assays have limited sensitivity in the first 14 days post‑symptom onset and reach substantially higher sensitivity after >14 days; IgM has limited diagnostic utility and should not be relied upon alone for diagnosis.
Antigen testing: sensitivity is variable and generally lower than molecular assays; negative antigen results should be considered presumptive and confirmed with an FDA‑authorized molecular assay when clinically indicated; positive antigen results do not distinguish viable virus and may have rare cross‑reactivity considerations.
Multiplex panel testing: panels must be used on specified instrument platforms, are not validated for asymptomatic screening or treatment monitoring, and negative panel results do not exclude infection due to sequence variants, inhibitors, sampling issues, or pathogens not included on the panel.
Operational/specimen limitations: some antigen EUA performance data were obtained using frozen specimens and may differ with fresh POC samples; follow manufacturer instructions (e.g., device modes) to ensure intended performance.
Interpretation caution: neutralizing antibody titers and overall antibody responses vary by age and disease severity; serology is better suited for epidemiology or late‑phase/post‑infectious assessments than early diagnosis.
Coverage-related clinical criteria
Clinical use limitations and recommended follow‑up when using multiplex panels and related assays:
Multiplex respiratory panels (e.g., BioFire RP2.1, QIAstat‑Dx, ePlex RP2) are intended for patients with suspected respiratory infection and are not established for asymptomatic screening.
Panel positive or negative results should not be used as the sole basis for diagnosis or management; combine results with clinical assessment and epidemiologic information or perform confirmatory testing when indicated.
Do not use BioFire RP2.1 when B. pertussis is suspected due to low sensitivity; use an FDA‑cleared B. pertussis molecular assay targeting IS481 instead.
If a panel detects four or more organisms in a single sample, retest the sample to confirm results.
When panels cannot reliably differentiate closely related viruses (e.g., rhinovirus vs enterovirus, influenza A subtypes, SARS‑CoV‑2 variants), perform follow‑up testing with alternate methods such as culture or sequencing as required.
Testing guidance and criteria (clinical and public health)
Clinical and public‑health testing recommendations reflected in guidance and evidence:
Recommend NAAT (including PCR) for symptomatic individuals; NAATs are highly sensitive and specific and generally preferred for diagnostic confirmation.
Use antigen‑detecting rapid diagnostic tests (Ag‑RDTs) within 5–7 days of symptom onset per WHO guidance; Ag‑RDTs that meet minimum performance (≥80% sensitivity, ≥97% specificity vs NAAT) may be used where reliable and when community transmission is ongoing.
A single negative antigen test cannot rule out infection; follow CDC recommendations for repeat antigen testing (e.g., two negatives 48 hours apart for symptomatic) or confirm with NAAT when necessary.
Acceptable specimen types for NAAT include NP, AN, OP, MT swabs, saliva, or mouth gargle as indicated by assay labeling; failure to adhere to FDA labeling/EUA for specimen type can lead to inaccurate results and reimbursement denials.
Pooled testing may be used for screening to conserve resources, but sensitivity varies with pool size and method and is assay/EUA dependent.
WGS/NGS is useful for surveillance and variant identification but has practical limitations (cost, infrastructure) and no FDA‑approved WGS tests as of May 4, 2022.
Serology has limited role for diagnosing active infection and should not be used to determine immune status for return‑to‑work or 'immunity passports'; it is useful in specific clinical scenarios (e.g., MIS‑C evaluation) and seroprevalence studies.
Public‑health case definitions and guidance (CDC WHO IDSA etc.) for MIS‑C, MIS‑A, and long COVID are summarized and should guide testing strategies in conjunction with clinical criteria.
IDSA NAAT testing recommendations
IDSA recommendations and near‑term operational considerations relevant to coverage decisions:
Recommend SARS‑CoV‑2 NAAT for symptomatic individuals; positive NAAT results inform therapy, isolation, and contact tracing.
Acceptable specimen types include NP, AN, OP, midturbinate swabs, saliva, and mouth gargle; AN or OP alone may have higher false negative rates compared with combined or other specimen types—follow assay labeling or validated LDT procedures.
AN and MT swabs may be self‑collected or provider‑collected for symptomatic persons when supported by the assay and collection instructions.
Do not routinely repeat NAAT after a negative initial test; consider repeat testing 24–48 hours later if new/worsening symptoms or concern for poor specimen quality.
Suggest testing asymptomatic individuals with known/suspected exposure ideally ≥5 days after exposure unless symptoms develop earlier.
Suggest against routine pre‑admission/pre‑procedure NAAT for asymptomatic individuals without known exposure; consider targeted testing in high‑risk settings (e.g., multibed rooms, transplant/CAR‑T recipients) or high community transmission.
Do not use NAAT Ct values alone to determine infectivity or to routinely guide release from isolation or timing of procedures.
Either rapid or standard laboratory‑based NAATs may be used for symptomatic and exposed asymptomatic individuals; performance varies by platform and specimen type.
Serology is not recommended for diagnosis in the first two weeks of symptoms; consider serology 3–5 weeks after onset to assess prior infection and prefer nucleocapsid‑targeting assays when assessing prior infection in vaccinated individuals.
SARS‑CoV‑2 genotyping/ sequencing currently has limited routine clinical use but may be considered for surveillance or when variant‑specific clinical/therapeutic implications exist.
SHEA and allied societies recommend against routine universal asymptomatic screening in healthcare facilities; consider targeted admission screening during increased community transmission or when controls are limited.
Pediatric considerations: children recently infected within 3 months may remain NAAT‑positive; antigen tests may be preferable to NAAT within the 90‑day window for symptomatic exposed children in some contexts.
For MIS‑C diagnosis, include IgG antibody testing and NAAT to provide evidence of current or recent SARS‑CoV‑2 infection per CDC/IDSA guidance.
Evidence and guidance sources
Primary evidence and guidance sources that inform the coverage criteria:
Systematic reviews and meta‑analyses of serologic and antigen test accuracy (e.g., Lisboa Bastos et al., Fox et al.).
Regulatory summaries and FDA EUA device instructions for antigen, molecular, and multiplex assays cited for analytical and operational details.
Public health guidance from WHO, CDC, and ECDC on testing strategies, antigen use, specimen selection, and isolation/retesting intervals.
Evidence on alternative and emerging methods (RT‑LAMP, CRISPR‑based assays, pooled testing studies) and sequencing resources for surveillance and variant monitoring.
Professional society guidelines (IDSA, AAP, SHEA/ASA/APSF, AACC) providing recommendations for clinical testing, perioperative screening, serology use, and institutional screening policies.
Coding and Reimbursement Rules
Reimbursement billing rulesmixed
| HCPCS/CPT | Only one code per date of service will be reimbursed; do not bill both HCPCS and AMA code for same procedure same DOS. |
| Specimen collection codes | Specimen collection codes for coronavirus testing are incidental and will not be reimbursed. |
RT-PCR analytic performance (examples)mixed
| Examples of analytical limits of detection for RT-PCR assays (e.g., CDC diagnostic panel LoD 1.0 - 3.2 copies/µL; WHO E gene 3.9 copies/reaction, RdRp 3.6 copies/reaction; study example LoD 689.3 copies/mL / 275.72 copies per reaction at 95% detection probability). |
Multiplex respiratory panel targets (examples)mixed
| Panel targets include: Adenovirus; HCoV 229E; HCoV HKU1; HCoV NL63; HCoV OC43; SARS-CoV-2; Human metapneumovirus; Human rhinovirus/enterovirus; Influenza A (H1, H3, H1-2009); Influenza B; Parainfluenza viruses 1-4; Respiratory syncytial virus A/B; Bordetella parapertussis; Bordetella pertussis; Chlamydia pneumoniae; Mycoplasma pneumoniae. |
Noted test targets affecting sensitivitymixed
| IS481 | Multi-copy insertion sequence (IS481) targeted by more sensitive Bordetella pertussis tests; BioFire RP2.1 targets single-copy ptxP and thus has lower sensitivity for B. pertussis. |
Pooled testing (EUA-authorized)mixed
| EUAs have been issued for pooled-sample approaches (examples: UCSD RC SARS-CoV-2 Assay - 5-sample RT-PCR pool; Poplar SARS-CoV-2 TMA Pooling assay - 7-sample; LabCorp COVID-19 RT-PCR Test - 5-sample). Studies demonstrated detection in pools up to 32 samples (with increased false-negative risk). |
Test modality classification (informational)mixed
| Rapid NAAT | NAATs with analytic turnaround typically ≤30–60 minutes (includes rapid RT-PCR and rapid isothermal NAAT) suitable for near-patient/POC use. |
| Standard NAAT | Laboratory-based NAATs requiring instrumentation and trained laboratory staff; longer turnaround times. |
Diagnostic test types citedmixed
| No codes listed |
inv-15: RT-PCR analytical sensitivity example — CDC diagnostic panel LoD ~1.0 - 3.2 copies/µL
CDC diagnostic panel LoD~1.0 - 3.2 copies/µL reported for the CDC RT-PCR diagnostic panel
WHO RT-PCR gene targets (example LoD)E gene LoD ~3.9 copies/reaction; RdRp gene LoD ~3.6 copies/reaction
High-throughput platform exampleStudy example LoD reported 689.3 copies/mL (275.72 copies per reaction at 95% detection probability)
inv-16: Serology sensitivity (pooled ELISA) — 84.3% pooled sensitivity
Pooled ELISA sensitivity (meta-analysis)Pooled sensitivity for ELISAs (IgG/IgM) = 84.3% (95% CI 75.6%–90.9%)
LFIA pooled sensitivityLateral flow immunoassays pooled sensitivity = 66% (95% CI 49.3%–79.3%)
CLIA pooled sensitivityChemiluminescent immunoassays pooled sensitivity = 97.8% (95% CI 46.2%–100%)
inv-17: Limit of detection example (Quidel Sofia2) — TCID50 direct swab: 113/mL; diluted swab: 850/mL
Quidel Sofia®2 antigen LoD (direct swab)TCID50 = 113 per mL for direct swab samples
Quidel Sofia®2 antigen LoD (diluted swab)TCID50 = 850 per mL when swab diluted into 3 mL of reagent
Clinical PPA exampleClinical studies reported ~80% positive percent agreement in evaluated frozen-sample studies
inv-18: Limit of detection (LoD) — BioFire RP2.1: 160-500 copies/mL; QIAstat-Dx: 500 copies/mL; ePlex RP2: 250 copies/mL
BioFire RP2.1 LoDReported LoD 160–500 copies/mL depending on isolate (160 copies/mL with infectious CDC isolate; 500 copies/mL with heat-inactivated USA-WA1/2020)
QIAstat-Dx Respiratory SARS-CoV-2 LoDReported LoD = 500 copies/mL
ePlex RP2 LoDReported LoD = 250 copies/mL (0.01 TCID50/mL corresponds to 250 genomic copies/mL)
inv-19: Ag-RDT performance threshold — Sensitivity ≥80%, Specificity ≥97% (compared to NAAT)
WHO minimum performance requirement for Ag-RDTsSensitivity ≥80% and Specificity ≥97% compared to a NAAT reference assay
Recommended use windowWHO recommends Ag-RDT use within 5–7 days of symptom onset when viral load is higher
Context for useAg-RDTs suitable when community transmission is ongoing (≥5% test positivity); NAAT preferred in low-transmission settings
inv-20: Rapid NAAT turnaround — Typically ≤30–60 minutes for testing run time (does not include transport or reporting)
Typical rapid NAAT analytical run timeTypically ≤30–60 minutes for testing run time (inclusive of extraction and detection; excludes transport and reporting time)
Rapid NAAT characteristicsFew operator steps and amenable to near-patient or point-of-care use; includes rapid RT-PCR and rapid isothermal NAATs
Definition variabilityDifferent authorities define rapid NAAT turnaround variably (≤30 minutes by some, ≤60 minutes by others)
Provider Actions, Operational Notes, and Documentation
Note
Applicability and exclusion
This policy applies only to testing performed for medical decision-making in the outpatient setting and does not apply to testing conducted for work, school, state, or federally mandated purposes.
Note
Use and limitations of RT‑PCR
RT‑PCR (NAAT) is the primary method to diagnose acute SARS‑CoV‑2 infection when performed with appropriate primers and specimen types; however, RT‑PCR results can fluctuate over time and a negative RT‑PCR does not exclude infection and must be interpreted with clinical observations, patient history, and epidemiologic information.
- RT‑PCR detects viral RNA and is not suitable for identifying past infection.
- Reports of initial negative RT‑PCR followed by later symptomatic disease may reflect improper collection or testing early in the incubation period.
Note
Use and limitations of serology
Host antibody (serologic) testing should not be used to diagnose or exclude acute SARS‑CoV‑2 infection; interpretation is limited by timing of seroconversion and it is currently unknown whether positive antibody results indicate protective immunity or its duration.
- Antibody tests may indicate prior exposure but are not diagnostic of acute infection.
- Positive IgG may reflect prior infection or cross‑reactivity; clinical significance for immunity remains uncertain.
Prior Authorization
Confirmatory testing and POC procedure requirements
Negative antigen (Ag) test results should be treated as presumptive and, when necessary for clinical management or infection control, confirmed with an FDA‑authorized molecular assay; point‑of‑care antigen procedures must be performed exactly according to the manufacturer/system instructions.
- Follow the specific system requirements (e.g., Sofia®2 must be run on the Sofia®2 system and per the test procedure).
- Positive antigen results do not distinguish viable virus and may not rule out coinfections.
Documentation Required
Operational testing notes
For multiplex respiratory panels, if a sample returns four or more organisms detected the sample should be retested; these panels have not been established for use in persons without signs or symptoms and are not validated for asymptomatic screening or treatment monitoring.
- Panels must be used on their intended instrument systems (e.g., BioFire FilmArray 2.0 or Torch).
- A negative panel result does not necessarily exclude infection due to variants, inhibitors, sample mix‑up, organisms not on the panel, or lower respiratory tract infection not sampled by NP swab.
Documentation Required
Result interpretation and follow‑up
Panel positive or negative results should not be the sole basis for diagnosis or patient management; follow‑up testing or alternative methods (e.g., culture, sequencing) are recommended when differentiation between closely related viruses or confirmation is clinically required.
- If the panel cannot reliably differentiate viruses (e.g., rhinovirus vs enterovirus), pursue alternate testing.
- Combine panel results with clinical observations, patient history, and epidemiology before making management decisions.
Documentation Required
Ordering and documentation actions for providers
Order tests consistent with FDA labeling/EUA for specimen type and collection instructions; NAATs are generally preferred for symptomatic individuals, and providers should recognize NAATs may remain positive for up to 90 days which affects retesting decisions.
- Ensure specimen collection and transport follow the assay's FDA‑authorized instructions unless an LDT validation or EUA authorizes alternative specimen types.
- Whole genome sequencing has practical limitations (cost, reagents, infrastructure) and, as of May 4, 2022, no FDA‑approved WGS tests exist.
Denial Risk
Adherence to test labeling and validation
Failure to adhere to FDA label requirements for specimen/collection type, unless validated as an LDT or authorized by an EUA for alternate specimens, can lead to inaccurate results and reimbursement denials.
- Confirm that the specimen type and collection method match the assay's authorized labeling before submitting for reimbursement.
Step Therapy
Targeted screening and institutional risk assessment
Facilities should perform local risk–benefit analyses and may limit or discontinue universal asymptomatic screening in favor of targeted testing based on facility layout, patient population, and community transmission.
- Consider admission or preprocedure testing selectively (e.g., multibed rooms, congregate care, high community transmission) rather than routine universal screening.
- Develop facility‑specific policies incorporating local infection prevention controls.
Note
Regulatory and guidance references
Consult cited regulatory and public health guidance (FDA EUA listings and device summaries, WHO and CDC testing guidance, and professional society recommendations) for up‑to‑date operational and regulatory context when selecting and interpreting diagnostic tests.
- Use FDA EUA summaries and the FDA In Vitro Diagnostics EUA list to confirm authorized specimen types and pooling instructions.
- Refer to WHO and CDC guidance for antigen use windows, repeat testing recommendations, and public health case definitions.
Definitions and Terminology
inv-31: SARS-CoV-2 / COVID-19 — SARS-CoV-2 is the virus that causes COVID-19; testing modalities include molecular (RT-PCR), antigen, and antibody tests.
Agent and diseaseSARS-CoV-2 is the virus that causes COVID-19
Primary testing modalitiesTesting modalities include molecular NAAT/RT-PCR, antigen detection, and host antibody (serology) tests
RT-PCR clinical roleRT-PCR detects viral RNA for diagnosis of acute infection; not used to detect past infection
inv-32: Terminology — Extensive table of terminology and abbreviations related to coronavirus testing (e.g., RT-PCR, NAAT, Ag-RDTs, MIS-C, MIS-A, WGS).
Ag-RDTs abbreviationAg-RDTs = Antigen-detecting rapid diagnostic tests
NAAT abbreviationNAAT = Nucleic acid amplification test
LoD abbreviationLoD = Limit of detection
WGS/NGS termsWGS = Whole genome sequencing; NGS = Next-generation sequencing
inv-33: RT-PCR definition — Reverse transcription polymerase chain reaction — molecular test that detects SARS-CoV-2 RNA for diagnosis of acute infection; not for detecting past infection.
RT-PCR definitionReverse transcription polymerase chain reaction (RT-PCR): molecular test that detects SARS-CoV-2 RNA for diagnosis of acute infection
LimitationsRT-PCR requires appropriate specimen type and timing; results may fluctuate and cannot be used to detect past infection
CDC panel compositionCDC diagnostic panel uses two N-gene primer/probe sets plus human RNase P control
inv-34: Binding vs neutralizing antibody tests — Binding antibody tests detect presence of antibodies; neutralizing antibody tests measure antibodies capable of preventing viral infection.
Binding vs neutralizing antibody testsBinding antibody tests detect presence of antibodies (IgM/IgG/total); neutralizing antibody tests measure antibodies capable of preventing viral infection and report titers
Timing of antibody productionIgM appears first, IgG later; neutralizing antibodies often detected days 4–6 and peak days 10–15
Clinical implicationsSerology not for acute diagnosis; useful for prior infection assessment and certain syndromes (e.g., MIS-C)
inv-35: Variant classifications — Variants being monitored (VBM), VOI, VOC, VOHC with criteria described.
CDC variant classificationsVariants classified as VBM, VOI, VOC, and VOHC based on transmissibility, severity, immune escape, and public health impact
VOI attributesVOI may have genetic markers predicted to affect transmission, diagnostics, therapeutics, or immune escape
VOC attributesVOC associated with increased transmissibility, more severe disease, reduced neutralization, or reduced effectiveness of countermeasures
inv-36: Antigen testing — Antigen testing definition and context.
Antigen testing definitionAntigen testing detects viral proteins (e.g., spike or nucleocapsid) and provides rapid results but is generally less sensitive than NAATs
Use contextAntigen tests are useful for rapid detection but negative results may require confirmation with NAAT
Turnaround timeAntigen tests often produce results in 15–30 minutes
inv-37: Neutralizing antibody (NAb) — NAb timing and brief characteristics.
Neutralizing antibody (NAb) timingNAbs detected starting days 4–6 and peak around days 10–15 in mild cases
Titer variabilityNAb titers vary substantially by age and disease severity
Clinical uncertaintyImplications of differing NAb titers for protection against future infection remain uncertain
inv-38: Panel testing — Multiplex respiratory panels definition and scope.
Multiplex panel definitionMultiplex respiratory panels detect multiple respiratory pathogens from a single specimen using assay-specific instruments (e.g., BioFire, QIAstat-Dx, ePlex)
Use limitationsPanels are not established for specimens from individuals without signs or symptoms and results should not be sole basis for management
Retest recommendationIf four or more organisms are detected in a sample, retesting is recommended
inv-39: Negative result — Negative predictive limitation definition.
Negative result limitationA negative result does not necessarily exclude infection due to sequence variants, inhibitors, technical error, sample mix-up, non-panel organisms, or lower respiratory tract infection not detected by NP swab
Clinical interpretationNegative results must be combined with clinical observations, patient history, and epidemiologic information
Confirmatory testingConsider follow-up testing or alternative methods when clinical suspicion remains high
inv-40: Cross-reactivity — Cross-reactivity risk definition.
Cross-reactivity risk (BioFire RP2.1)BioFire RP2.1 primers may cross-react with certain bat and pangolin coronaviruses (accessions listed), potentially producing a detected SARS-CoV-2 signal
Panel cross-reactivity examplesRP2.1 shows cross-reactivity with B. bronchiseptica and B. parapertussis at higher concentrations
Pertussis sensitivity noteRP2.1 should not be used when B. pertussis is suspected due to low sensitivity versus IS481-targeting assays
inv-41: RT-LAMP — Reverse transcription loop-mediated isothermal amplification definition.
RT-LAMP definitionReverse transcription loop-mediated isothermal amplification (RT-LAMP): isothermal NAAT method providing faster results than traditional RT-PCR
Detection methodSome RT-LAMP assays use colorimetric indicators to detect amplified product without specialized instrumentation
Use caseRT-LAMP can combine speed of antigen tests with NAAT accuracy but detection without instrumentation remains a challenge
inv-42: NAAT — NAAT (nucleic acid amplification test) definition.
NAAT definitionNucleic acid amplification test (NAAT): molecular assays (including RT-PCR) that detect viral RNA and are highly sensitive and specific
Clinical considerationsNAATs may remain positive up to 90 days post-infection and are preferred for diagnosing acute infection
Includes methodsNAAT methods include standard RT-PCR and rapid isothermal amplification techniques
inv-43: Ag-RDT — Antigen-detecting rapid diagnostic tests definition.
Ag-RDT definitionAntigen-detecting rapid diagnostic tests (Ag-RDTs) detect viral proteins and provide faster results but are generally less sensitive than NAATs
Role in testingAg-RDTs useful for symptomatic testing within early illness window and for rapid screening in high-transmission settings
Performance caveatA single negative antigen test cannot rule out infection; repeat testing or NAAT confirmation may be needed
inv-44: Pooled testing — Pooling definition and implications.
Pooling definitionPooling combines multiple specimens into a single test to conserve resources; sensitivity can decrease with larger pools
EUA-authorized pooling examplesEUAs exist for assays permitting specific pool sizes (e.g., 5–7 samples in cited EUAs)
Study exampleA study detected a single positive in pools up to 32 samples with ~10% false-negative rate
inv-45: WGS — Whole genome sequencing definition and limitations.
WGS definitionWhole genome sequencing (WGS): genomic analysis for surveillance and variant identification; useful for outbreak investigation
Practical limitationsWGS limited by high cost, reagent shortages, infrastructure and trained staff; no FDA-approved WGS tests as of May 4, 2022
Surveillance roleWGS aids variant monitoring, outbreak linkage, and public health decision-making
inv-46: Symptomatic individuals — Symptomatic (IDSA) definition/context.
Symptomatic individuals (IDSA)Symptomatic defined as at least one common COVID-19 symptom (fever/chills, cough, shortness of breath, fatigue, myalgias, headache, sore throat, new loss of taste/smell, congestion, nausea/vomiting, diarrhea)
Testing recommendationIDSA recommends SARS-CoV-2 NAAT for symptomatic individuals
Specimen considerationsCollection ability and specimen type affect test choice and performance
inv-47: Known exposure — Known exposure definition/context.
Known exposure definitionClose contact for ≥15 minutes over 24 hours with someone with laboratory-confirmed COVID-19; suspected exposures include working/residing in congregate outbreak settings
Testing timing after exposureIDSA suggests testing asymptomatic exposed persons ≥5 days after exposure unless symptoms develop earlier
Exposure risk factorsRisk varies by duration, indoor vs outdoor setting, mask use, and household contacts higher risk
inv-48: Rapid NAAT — Rapid NAAT definition/context.
Rapid NAAT definitionRapid NAATs are NAATs with analytical turnaround often defined as ≤30–60 minutes for testing run time (excludes transport/reporting) suitable for near-patient use
Method examplesIncludes rapid RT-PCR and rapid isothermal NAATs; typically have few operator steps
Performance variabilityDefinitions and performance vary by authority and platform; specimen type may affect sensitivity
inv-49: EUA — EUA (Emergency Use Authorization) definition and regulatory note.
EUA definitionEmergency Use Authorization (EUA): FDA regulatory mechanism for diagnostic devices during the public health emergency; device EUA summaries cited
EUA implicationsPerformance claims and approved specimen types depend on EUA labeling; deviation without validation may affect reimbursement
EUA sourcesFDA EUA summaries and device instructions are referenced for assay performance and intended use
inv-50: WGS/NGS — Whole genome sequencing (WGS) and NGS definition and context.
WGS/NGS definitionWhole genome sequencing (WGS) and NGS: sequencing approaches for SARS-CoV-2 surveillance and variant analysis
Regulatory contextFDA has issued information on COVIDSeq and other NGS tests (EUA summaries referenced)
Practical considerationsNGS/WGS require specialized infrastructure and trained personnel; useful for public health surveillance and outbreak response
Policy Summary
PayerCapital Bluecross
PolicyCoronavirus Testing in the Outpatient Setting
Policy CodePolicy AHS - G2174
Change TypeRetirement (no material revision noted)
Effective DateSep 18, 2015
Next Review Date
Key ActionFollow specimen type and collection instructions per FDA labeling/EUA; NAATs are generally preferred for symptomatic individuals and negative antigen results should be confirmed with an FDA‑authorized molecular assay when clinically indicated.
SourceLink
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