SARS Cov2 laboratory
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Epidemiology
* implications for maximum sensitivity detecting Omicron infection
Laboratory
- complete blood count (CBC)
- lymphopenia (63%)[1][11], neutropenia may occur in the elderly[8]
- elevated RDW on admission & increasing RDW during hospitalization associated with higher mortality risk[42]
- pulse oximetry may reveal hypoxemia (even in the absence of dyspnea)[22]
- prothrombin time, plasma fibrinogen[21]
- elevated serum LDH, elevated serum C-reactive protein, elevated serum IL6 & serum ferritin (markers of inflammation), elevated D-dimer
- elevated plasma D-dimer risk factor for mortality in Wuhan patients[5]
- plasma D-dimer is elevated in most Covid-19 patients
- a normal plasma D-dimer excluses pulmonary embolism[93]
- elevated serum troponin-T associated with increased mortality[20]
- serum procalcitonin to rule out bacterial pneumonia associated with less antibiotic initiation[110]
- high serum cortisol on admission predicts mortality[54]
- chemistry panel
- high serum glucose on hospital admission predicts severity & mortality (RR=2)[59]
- liver function tests (may be elevated due to COVID-19 &/or due to treatment)[39]
- elevated serum ALT & serum AST (14-53%)[39]
- elevated serum bilirubin (total) (17%)[39]
- vitamin D deficiency of unclear relationship to COVID-19[43]
- serum 25-OH vitamin D < 30 ng/mL may be associated with higher mortality[43]
- low serum 25-OH vitamin D associated with higher serum C-reactive protein & lymphopenia[43]
- no consistent relationship of vitamin D deficiency with COVID-19
- SARS-CoV2 seropositivity is not associated with low serum 25-OH vitamin D independent of other risk factors[85]
- serum 25-OH vitamin D < 30 ng/mL may be associated with higher mortality[43]
- low serum testosterone in men associated with severe cases of Covid-19[86]
- average serum testosterone of men admitted to ICU 49 ng/dL
- by day 3 of hospitalization average serum testosterone 19 ng/dL
- low serum testosterone found to correlate with signs of inflammation[86]
- no proof that low serum testosterone causes more severe Covid-19[86]
- low serum testosterone may serve as a risk factor or prognostic indicator[36]
- neurofilament light chain in serum
- total tau in serum, p-tau181 in serum & GFAP in serum are significantly elevated in patients with Covid-19 encephalopathy & in Covid-19 patients who die in-hospital
- total tau in serum & GFAP in serum are significantly lower in patients with Covid-19 who are discharged home
- do not perform stool testing for COVID-19[39]
SARS CoV2 RNA
- SARS-CoV2 RNA
- specimen: (% positive in patients with known COVID-19)[7]
- bronchoalveolar lavage (93%), sputum (72%), nasal swab (63%). bronchial brush biopsy (46%) pharyngeal swabs (32%), feces (29-41%), blood (1%)
- 70% of patients with persistently positive stool RNA even after respiratory RNA had become negative[24][50]
- found in semen of 16% of men with COVID-19[33]
- not found in urine[7]
- highest viral loads found in nasal swabs[7]
- video on obtaining nasopharyngeal swab (standard for screening)[25]
- illustration of obtaining nasopharyngeal swab[53]
- self-collected midnasal swabs with 80% sensitivity & 98% specificity relative to nasopharyngeal swab in symptomatic patients
- saliva yields greater detection sensitivity & consistency throughout the course of infection than nasopharyngeal swabs[30][38]
- SalivaDirect used by NBA is FDA-approved for emergency use
- saliva & healthcare worker-collected nasopharyngeal swabs performed similarly & better than self-collected nasal swabs[44]
- saliva testing has similar sensitivity & specificity to nasopharyngeal testing[70]
- saliva testing sensitivity 71% of nasopharyngeal testing during 1st week of Covid-19 infection[91]
- saliva more likely positive in symptomatic vs asymptomatic people (88% vs 58%)
- saliva testing performs best in patients with high nasopharyngeal viral loads
- sensitivity of saliva vs nasopharyngeal testing drops to <20% after 4 weeks[91]
- no discussion of false positives with nasopharyngeal testing found
- conjunctival swabs positive from one eye but not the other in 23%[77]
- sensitivity of a negative RT-PCR is 70% (seems to refer to predictive value of a negative test); sensitivity of a positive RT-PCR is allegedly better[18]
- RT-PCR becomes positive 5-7 days after exposure
- RT-PCR may remain positive after clinical recovery
- median duration to negative RT-PCR tests of upper respiratory tract is 11 days (95% CI 10-12 days)[12]; 3 weeks[29]; 17 days[57]
- median duration of viral RNA in stool samples is 17-22 days, compared with 15-18 days in lower respiratory tract & 16-17 days in serum samples[26][57]
- for patients with severe disease, median duration of the virus in respiratory samples is 21 days, versus 14 days with mild disease[26]
- maximum shedding duration is 83 days from upper respiratory tract, 59 days 126 days in stools, & 60 days in serum[57]
- China is beginning testing anal swabs[72]
- live virus is not detected beyond day 9 of illness, despite persistently high viral loads inferred from PCR cycle threshold values[57]
- ref[32] shows time course virus-specific testing likely positive -
- CDC recommends against testing same nursing home resident > once a day[51]
- CDC says COVID-19 patients no longer need testing to come out of isolation if:
- 10 days have past since onset of symptoms
- afebrile for > 24 hours (no antipyretics)
- asymptomatic (dyspnea & diarrhea specifically cited)[15]
- CDC calls for all individuals even if fully vaccinated to be tested for COVID-19 following exposure even if asymptomatic[89][34]
- assay using CRISPR technology as specific & more sensitive than RT-PCR in detecting SARS-CoV2 from clinical samples & may be done in <30 minutes[47]
- process is isothermal reverse transcriptase loop mediated isothermal amplification (RT-LAMP) with DNA endonuclease-targeted CRISPR trans reporter (DETECTR)[47]
- rt-PCR detection of B.1.1.7 variant (UK) may result in false negatives with:
- Accula SARS-CoV-2 Test (Mesa Biotech Inc.)
- Linea COVID-19 Assay Kit (Applied DNA Sciences, Inc.)
- TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, Xpert Omni SARS-CoV-2 (Cepheid)
- rt-PCR detection of omicron variant with Tide Laboratories LLC is expected to fail due to a 9-nucleotide deletion in the N-gene, spanning positions 28370-28362; the single genetic target of this test covers the portion of the N-gene where the deletions occur[95]
- a PCR that uses flurescently labeled probes called "sloppy molecular beacons" that glow in different colors when they attach to RNA or DNA can identify all current variants of SARS CoV2, including alpha, beta, gamma, delta & omicron[100]
- when the sample is heated, the probes fall off at different temperatures characteristic of the probe sequence & the Covid-19 variant & their color disappears
- color & temperature of color transition identify the variant[100]
- Roche is launching a SARS-CoV-2 variant test to help monitor emerging SARS-CoV2 mutations[78]
- specimen: (% positive in patients with known COVID-19)[7]
- viral rebound occurs in 31%[108]
Serology
- Serology:[74]
- qualitative detection of IgM & IgG Ab against SARS-CoV-2 in serum, plasma (EDTA or citrate), or whole blood (FDA approved for emergency use)[17]
- most antibodies recognize viral nucleocapsid antigen[32]
- optimal specificity & sensitivity at day 14[46]
- antibody (especially IgA) to spike protein more likely to confer immunity
- most antibodies recognize viral nucleocapsid antigen[32]
- 3 specific Ab SARS-CoV-2 infection (10% false-negatives, 5% false-positives)[46]
- 30% of patients with very low levels of SARS-CoV-2-specific antibodies; 6% with undetectable antibody titers[23]
- 94% of COVID-19 patients show a decline in antibody levels at 60 days & 28% have undetectable levels; lower antibody levels associated with less severe disease[62]
- sensitivity of IgG/IgM Ab for SARS-CoV-2 during 1st week of symptoms is 30%, increasing to 91% during the 3rd week[56]
- specificity of IgG/IgM Ab for SARS-CoV-2 is > 98%[56]
- no evidence antibodies confer immunity[27][55]
- SARS CoV-2 spike protein specific IgG with plasma 1/2 life of 36 days[16]
- FDA authorizes SARS CoV2 neutralizing antibodies test[49]
- no evidence that neutralizing Ab test detects confers any level of immunity[49]
- presence of anti-spike or anti-nucleocapsid IgG antibodies associated with reduced risk of SARS-CoV-2 reinfection in health care workers in the ensuing 6 months[64]
- semi-quantitative COVID-19 IgG testing kit (COVID-SeroKlir) FDA-approved & approved by the European Union.[58]
- anti-spike-protein IgG3 best for determining immunity[69]
- SARS-CoV2 IgG Ab reached a peak sensitivity of 0.75 112 days after positive RT-PCR[75]
- antibodies to the receptor binding domain of the spike glycoprotein are present in 99% of Covid-19 confirmed survivors, 55% of Covid-19 unconfirmed persons & 11% of persons without Covid-19[101]
- SARS-CoV2 serology to assess immunity is flawed, utility questionable[93]
- qualitative detection of IgM & IgG Ab against SARS-CoV-2 in serum, plasma (EDTA or citrate), or whole blood (FDA approved for emergency use)[17]
Viral culture
- in hospitalized patients with COVID-19 median time from symptom onset to
- negative viral culture is 7 days
- negative RT-PCR is 34 days[73]
Blood bank
- Blood bank:
- blood type (see COVID-19 (SARS CoV2) Genetics: subsection)
- T-detect COVID test identifies prior infection through T-cell DNA
- estimated prevalence of SARS CoV2 in blood donations 1.16/100,000[87]
- estimated viral loads of positive donations 1000-4000 copies/mL
- no infectivity observed in cell cultures of any blood donation[87]
Point-of-care tests
- Point of care diagnostic tests
- SARS CoV2 antigen testing
- Sofia SARS Antigen Fluorescent Immunoassay[28]
- BD Veritor system
- false positives noted[48]
- among symptomatic, sensitivity of 80%, specificity of 99%, positive predictive value (PPV) of 94%, negative predictive value (NPV) of 96%[68]
- among asymptomatic, sensitivity of 41%, a specificity of 98%, PPV of 33%, & NPV of 99%[68]
- Abbott BinaxNOW rapid antigen test is 64% sensitive among symptomatic & 36% sensitive among asymptomatic; specificity is 100%[71]
- Abbott BinaxNOW rapid antigen test is able to detect Omicron variant with similar performance[95]
- Quidel QuickVue antigen test is able to detect Omicron variant with similar performance as with other variants[95]
- Cepheid point of care test will deliver results ~45 minutes[9]
- Abbott labs delivers RT-PCR test with results in 15 minutes[10]
- caution using Abbott Fast COVID Test (may aerosolize virus)[10]
- sensitivity < 70%[35] (test used by White House)
- CovidNudge is a point of care RT-PCR test with 94% sensitivity & 100% specificity[41]
- NIRVANA, can simultaneously detect & sequence SARS-CoV2, influenza & other viruses[80]
- FDA warns of false negative Curative Inc rapid RT-PCR tests used in Los Angeles & other large metropolitan areas[67]
- analyzed by Curative's KorvaLabs thus may not be entirely 'point of care'
- QIAstat-Dx Respiratory SARS-CoV-2 Panel provides results in 1.7 hours
- sensitivity & specificity 99% compared with PCR[45]
- FDA issues emergency use authorization for Abbott BinaxNOW COVID-19 Ag Card, showing results directly on testing card (akin to typical pregnancy test)[37]
- Abbott's Panbio COVID-19 Ag Rapid Test Device with > 42% false positives[96]
- UC San Francisco developing rapid test that identifies spike protein Ab (sensitivity 89%) & N-protein Ab (sensitivity 98%), specificity 98% for both[83]
- test results in 30 minutes
- test uses SARS-CoV2 viral protein antigens spike-protein receptor-binding domain & N-protein terminal sequence fused to luminescent enzyme
- luminescence read with commercially available handheld luminometer[83]
- a point of care test combines two different CRISPR-Cas enzymes, Cas13 & Csm6, providing results in < 1 hour[90]
- highly specific detection of antigens with nasopharyngeal swab specimens[92]
- detection of SARS-CoV-2 nucleocapsid & spike receptor binding domain proteins down to 1 ng/mL (33 pM)
- results take less than 5 min[92]
- employs fluidic-atomic force microscopy mediated nanomechanical deflection method
- FDA-approves emergency use authorization for point-of-care test detects SARS CoV2 variants of concern & both influenza A & influenza B with a single nasal swab[105]
- SARS-CoV2 breathalyzer detects SARS-CoV2 aerosols in two exhaled breaths with results in < 60 seconds[109]
- SARS CoV2 antigen testing
* Omicron variant tends to stay localized in the upper respiratory tract, thus individuals may remain Covid-19 positive past the 5 day isolation period. A positive antigen test in the post 5-day isolation period may mean you are potentially infective.[99]
Home-based testing
- FDA approves first at-home COVID-19 diagnostic test (Lucira) available by prescription, results in 30 minutes or less[52]
- FDA approves diagnostic test for at home collection of patient samples to detect both COVID-19 & influenza A & B (flu)[61]
- RT-PCR for COVID-19 + Flu for use with Quest Diagnostics Self-Collection Kit
- collected sample is shipeed to a Quest Diagnostics laboratory for analysis[61]
- Ellume at home over-the-counter rapid COVID-19 test detects nucleocapsid antigens shed by SARS-Cov2 detected in self collected nasal swabs & analyzes them with a single use lateral flow immunoassay within a bluetooth-enabled analyzer, which transmits the result to a smartphone placed nearby with results in 20 minutes (screening test, confirmation needed, cost estimate $30)[63]
- symptomatic persons initially testing negative with a home antigen test should test again in 1-2 days because test sensitivity seems to peak several days after illness onset[102]
- Medicare will not pay for home Covid-19 tests at retailers[98]
- 8 of 20 at-home tests listed on FDA's website[104] had shelf-life extended
- Abbott BinaxNOW & the iHealth test had 3 or 6 month extensions depending upon lot number[103]
- shelf-life ranges from 4 months for Cue Health home test, to 18 months for Celltrion's DiaTrust test[103]
- unsupervised SARS-CoV2 rapid antigen testing with 3 commercial kits with 70-81% sensitivity during the Omicron period in the Netherlands[104]
Symptom-based screening
- Given that COVID-19 may be transmitted through aerosolized breath from asymptomatic individuals, symptom-based screening is likely ineffective[19]
- also see screening for COVID-19
Regulation
- Ref[6] discusses regulation of laboratory-developed tests, issues of access & quality
False positive tests
* If false positive COVID-19 test suspected [LAJH]
- SaO2 q4 hours.
- O2 via NP to keep O2 sat > 90%
- CBC, BMP, serum C-reactive protein, serum LDH, serum ferritin, & plasma D-dimer q3 days if < 2 L O2; qd of > 2 L O2
Testing of nursing home staff
- frequent testing & immunity-based staffing interventions may reduce transmission of SARS-CoV-2 in nursing homes[88]
* CMS requires nursing home staff to be tested for COVID-19[36]
Detection of aerosolized SARS-CoV2
* French hospital tests breathalyser to detect COVID-19[13]
- dogs can be trained to sniff out human cases of COVID-19[14] in 1 week
- Miami Heat, NBA basketball team using dogs to screen fans[14]
- dogs can detect COVID-19 in crowded places, including airports, with sensitivity of 92-97% & specificity of 91%[84];
- also see screening for Covid-19
Pooled surveillance
* Pooled surveillance testing may be useful for screening populations[60]
SARS CoV-2 in sewage
* Following SARS CoV-2 in sewage may provide population prevalence of virus in watershed of sewage drainage[76]
CDC Information for Laboratories
* See CDC Information for Laboratories[3]
SARS-CoV2 Viral Mutations: Impact on COVID-19 Tests
* See FDA: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests[79].
Additional terms
- screening for COVID-19; screening for SARS-CoV2
- severe acute respiratory syndrome coronavirus 2; SARS-CoV2; Wuhan coronavirus
References
- ↑ 1.0 1.1 Zhu N, Zhang D, Wang W et al A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. January 24, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/31978945 https://www.nejm.org/doi/full/10.1056/NEJMoa2001017
Munster VJ, Koopmans M, van Doremalen N et al A Novel Coronavirus Emerging in China - Key Questions for Impact Assessment. N Engl J Med. January 24, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/31978293 https://www.nejm.org/doi/full/10.1056/NEJMp2000929
Perlman S Another Decade, Another Coronavirus N Engl J Med. January 24, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/31978944 https://www.nejm.org/doi/full/10.1056/NEJMe2001126
Huang C, Wang Y, Li X et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020 Jan 24; PMID: https://www.ncbi.nlm.nih.gov/pubmed/31986264 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30183-5/fulltext
Chan JF, Yuan S, Kok KH et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: A study of a family cluster. Lancet 2020 Jan 24; PMID: https://www.ncbi.nlm.nih.gov/pubmed/31986261 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30154-9/fulltext - ↑ 2.0 2.1 World Health Organization (WHO) WHO, China leaders discuss next steps in battle against coronavirus outbreak January 28, 2020 News release. Beijing https://www.who.int/news-room/detail/28-01-2020-who-china-leaders-discuss-next-steps-in-battle-against-coronavirus-outbreak
- ↑ 3.0 3.1 Centers for Disease Control & Prevention (CDC) 2019 Novel Coronavirus, Wuhan, China Information for Laboratories https://www.cdc.gov/coronavirus/2019-ncov/lab/index.html
Lan L, Xu D, Ye G et al Positive RT-PCR Test Results in Patients Recovered From COVID-19. JAMA. Published online February 27, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32105304 https://jamanetwork.com/journals/jama/fullarticle/2762452 - ↑ Walker M FAQs About COVID-19 - Answers to frequently asked questions based on the latest medical research and public health data. MedPage Today. February 29, 2020 https://www.medpagetoday.com/infectiousdisease/covid19/85165
van Doremalen N, Bushmaker T, Morris DH et al Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. March 17, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32182409 https://www.nejm.org/doi/full/10.1056/NEJMc2004973 - ↑ 5.0 5.1 Lewis R Risk Factors for Death From COVID-19 Identified in Wuhan Patients. Medscape - Mar 09, 2020. https://www.medscape.com/viewarticle/926504
- ↑ 6.0 6.1 Sharfstein JM, Becker SJ, Mello MM. Diagnostic Testing for the Novel Coronavirus. JAMA. Published online March 9, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32150622 https://jamanetwork.com/journals/jama/fullarticle/2762951
- ↑ 7.0 7.1 7.2 7.3 Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, Tan W Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. Published online March 11, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32159775 https://jamanetwork.com/journals/jama/fullarticle/2762997
- ↑ 8.0 8.1 Wu C, Chen X, Cai Y et al Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. Published online March 13, 2020. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32167524 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2763184
- ↑ 9.0 9.1 Weixel N FDA authorizes first rapid, 'point of care' coronavirus test. The Hill. March 21, 2020 https://www.msn.com/en-us/health/health-news/fda-authorizes-first-rapid-point-of-care-coronavirus-test/ar-BB11vTxm
FDA News Release. March 21, 2020 Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-first-emergency-use-authorization-point-care-diagnostic - ↑ 10.0 10.1 10.2 Azad A FDA authorizes 15-minute coronavirus test. CNN. March 28, 2020 https://www.cnn.com/2020/03/27/us/15-minute-coronavirus-test/index.html
Pradhan R Abbott's Fast COVID Test Poses Safety Issues, Lab Workers Say. Kaiser Health News. April 23, 2020 https://khn.org/news/abbotts-fast-covid-test-poses-safety-issues-lab-workers-say/ - ↑ 11.0 11.1 Walker M Study: IL-7 May Help Severe COVID-19 Patients - Small case series in Belgium finds improvement in lymphocyte levels with immunotherapy. MedPage Today July 22, 2020 https://www.medpagetoday.com/infectiousdisease/covid19/87695
Laterre PF, Francois B, Collienne C et al Association of Interleukin 7 Immunotherapy With Lymphocyte Counts Among Patients With Severe Coronavirus Disease 2019 (COVID-19). JAMA Netw Open. 2020;3(7):e2016485 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32697322 Free article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2768536 - ↑ 12.0 12.1 Chen J, Qi T, Liu L et al Clinical progression of patients with COVID-19 in Shanghai, China. J Infect. 2020 Mar 19. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32171869
- ↑ 13.0 13.1 Woo Y French hospital tests new breathalyser machine to detect COVID-19. Reuters Health News. July 23 2020 https://www.reuters.com/article/us-health-coronavirus-france-test/french-hospital-tests-new-breathalyser-machine-to-detect-covid-19-idUSKCN24O1HP
- ↑ 14.0 14.1 14.2 Arias T, Ulloa C Chile wants Covid-19 sniffer dogs to help reopen public spaces. CNN Health July 22, 2020 https://www.cnn.com/2020/07/22/health/dogs-coronavirus-sniff-public-spaces-intl/index.html
Crist C Trained Dogs Can Identify COVID-19 Infections, Study Says. Medscape - Jul 30, 2020. https://www.medscape.com/viewarticle/934876
Jendrny P, Schulz C, Twele F et al Scent dog identification of samples from COVID-19 patients -a pilot study. BMC Infect Dis 20, 536. July 23, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32703188 Free PMC article https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-020-05281-3
Howard J Miami Heat lets dogs out to screen fans for Covid-19 -- but what does the science say? CNN health. Jan 28, 2021 https://www.cnn.com/2021/01/28/health/covid-19-miami-heat-dogs-explainer-wellness/index.html
Grandjean D, Sarkis R, Lecoq-Julien C et al Can the detection dog alert on COVID-19 positive persons by sniffing axillary sweat samples? A proof-of-concept study. PLoS One. 2020 Dec 10;15(12):e0243122. PMID: https://www.ncbi.nlm.nih.gov/pubmed/33301539 Free PMC article. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0243122 - ↑ 15.0 15.1 AMA Morning News July 23, 2020 New from CDC: Patients with COVID-19 no longer need tests to come out of isolation
- ↑ 16.0 16.1 Ibarrondo FJ et al Rapid Decay of Anti-SARS-CoV-2 Antibodies in Persons with Mild Covid-19. N Engl J Med July 21, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32706954 https://www.nejm.org/doi/full/10.1056/NEJMc2025179
Havers FP, Reed C, Lim Tet al Seroprevalence of Antibodies to SARS-CoV-2 in 10 Sites in the United States, March 23-May 12, 2020. JAMA Intern Med. Published online July 21, 2020. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32692365 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2768834
Brown TS, Walensky RP Serosurveillance and the COVID-19 Epidemic in the US. Undetected, Uncertain, and Out of Control. JAMA. Published online July 21, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32692350 https://jamanetwork.com/journals/jama/fullarticle/2768835
Menachemi N, Yiannoutsos CT, Dixon BE, et al. Population Point Prevalence of SARS-CoV-2 Infection Based on a Statewide Random Sample - Indiana, April 25-29, 2020. MMWR Morb Mortal Wkly Rep. ePub: 21 July 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32701938 Free article https://www.cdc.gov/mmwr/volumes/69/wr/mm6929e1.htm
Biggs HM, Harris JB, Breakwell L, et al. Estimated Community Seroprevalence of SARS-CoV-2 Antibodies - Two Georgia Counties, April 28-May 3, 2020. MMWR Morb Mortal Wkly Rep. ePub: 21 July 2020. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32701941 Free article https://www.cdc.gov/mmwr/volumes/69/wr/mm6929e2.htm - ↑ 17.0 17.1 Walker M First Antibody Test for COVID-19 Gets FDA Authorization. MedPage Today. April 2, 2020 https://www.medpagetoday.com/infectiousdisease/covid19/85772
FDA. Letter to Dr Li of Cellex. April 1, 2020 authorizing emergency use https://www.fda.gov/media/136622/download
Otto MA FDA Grants Emergency Authorization for First Rapid Antibody Test for COVID-19. Medscape - Apr 04, 2020. https://www.medscape.com/viewarticle/928150 - ↑ 18.0 18.1 Terry K Hard Truths From Infectious Disease Specialists Medscape - Apr 04, 2020. https://www.medscape.com/viewarticle/928146
- ↑ 19.0 19.1 Roxby AC, Greninger AL, Hatfield KM, et al. Detection of SARS-CoV-2 Among Residents and Staff Members of an Independent and Assisted Living Community for Older Adults - Seattle, Washington, 2020. MMWR Morb Mortal Wkly Rep. ePub: 3 April 2020. https://www.cdc.gov/mmwr/volumes/69/wr/mm6914e2.htm Chow EJ, Schwartz NG, Tobolowsky FA et al Symptom Screening at Illness Onset of Health Care Personnel With SARS-CoV-2 Infection in King County, Washington. JAMA. Published online April 17, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32301962 https://jamanetwork.com/journals/jama/fullarticle/2764953
- ↑ 20.0 20.1 Guo T, Fan Y, Chen M et al. Cardiovascular implications of fatal outcomes of patients with coronavirus disease 2019 (COVID-19). JAMA Cardiol 2020 Mar 27; PMID: https://www.ncbi.nlm.nih.gov/pubmed/32219356 Free PMC Article https://jamanetwork.com/journals/jamacardiology/fullarticle/2763845
- ↑ 21.0 21.1 Thachil J, Tang N, Gando S et al. ISTH interim guidance on recognition and management of coagulopathy in COVID-19 J Thromb Haemost 2020 Mar 25; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/32338827 https://onlinelibrary.wiley.com/doi/abs/10.1111/jth.14810
- ↑ 22.0 22.1 Xie J, Tong Z, Guan X, Du B, Qiu H. Clinical Characteristics of Patients Who Died of Coronavirus Disease 2019 in China. JAMA Netw Open. 2020;3(4):e205619 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32275319 Free Article
- ↑ 23.0 23.1 Orciari Herman A, Fairchild DG, Hefner JE SARS-CoV-2 Antibodies Undetectable in Some Recovered Patients. Physician's First Watch, April 13, 2020 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
Wu F, Wang A, Liu M et al Neutralizing antibody responses to SARS-CoV-2 in a COVID-19 recovered patient cohort and their implications. medRxiv preprint. April 2020 (not reviewed) https://www.medrxiv.org/content/10.1101/2020.03.30.20047365v1.full.pdf - ↑ 24.0 24.1 Cheung KS, Hung IF, Chan PP et al. Gastrointestinal manifestations of SARS-CoV-2 infection and virus load in fecal samples from the Hong Kong cohort and systematic review and meta-analysis. Gastroenterology 2020 Apr 3 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32251668 https://www.gastrojournal.org/article/S0016-5085(20)30448-0/pdf
- ↑ 25.0 25.1 Marty FM, Chen K, Verrill KA How to Obtain a Nasopharyngeal Swab Specimen. N Engl J Med. April 17, 2020 (video) PMID: https://www.ncbi.nlm.nih.gov/pubmed/32302471 https://www.nejm.org/doi/full/10.1056/NEJMvcm2010260
- ↑ 26.0 26.1 26.2 Zheng S, Fan J, Yu F et al Viral load dynamics and disease severity in patients infected with SARS-CoV-2 in Zhejiang province, China, January-March 2020: retrospective cohort study. BMJ 2020;369:m1443 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32317267 https://www.bmj.com/content/369/bmj.m1443
- ↑ 27.0 27.1 World Health Organization (WHO). April 24, 2020 "Immunity passports" in the context of COVID-19. https://www.who.int/news-room/commentaries/detail/immunity-passports-in-the-context-of-covid-19
- ↑ 28.0 28.1 Clark C COVID Antigen Tests: Coming to Case Counts Near You?
New guidance from national epidemiology group could remake surveillance. MedPage Today August 6, 2020 https://www.medpagetoday.com/infectiousdisease/covid19/87930 - ↑ 29.0 29.1 University of Pittsburg Medical Center. August 10, 2020 Retesting for COVID-19: UPMC Shares its Experience. https://www.upmc.com/media/news/081020-retesting-for-covid19
Kennedy AJ, Hilmes MK, Waddell L et al Re-Testing for SARS-CoV-2: Patterns of Testing from a Large U.S. Healthcare System. Infection Control & Hospital Epidemiology. August 10, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32772941 https://www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/retesting-for-sarscov2-patterns-of-testing-from-a-large-us-healthcare-system/582B4BE74C3C010F9C388DA1AE3E11CC - ↑ 30.0 30.1 Wyllie AL, Fournier J, Casanovas-Massana A et al Saliva is more sensitive for SARS-CoV-2 detection in COVID-19 patients than nasopharyngeal swabs. MedRxiv. Posted April 22, 2020. Not indexed in PubMed https://www.medrxiv.org/content/10.1101/2020.04.16.20067835v1
Landry ML, Criscuolo J, Peaper DR. Challenges in use of saliva for detection of SARS CoV-2 RNA in symptomatic outpatients. J Clin Virol. 2020 Jul 31;130:104567. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32750665 Free PMC article. - ↑ 31.0 31.1 31.2 Young K, Sofair A, Chavey WE COVID-19: Positive Retests / Federal Prisons / Mental Health / Miscarriage. Physician's First Watch, April 30, 2020 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
Czachor E SOUTH KOREA EXPERTS SAY RECOVERED CORONAVIRUS PATIENTS RETESTED POSITIVE BECAUSE OF 'DEAD' VIRUS PARTS. Newsweek. April 29, 2020 https://www.newsweek.com/south-korea-experts-say-recovered-coronavirus-patients-retested-positive-because-dead-virus-parts-1500998 - ↑ 32.0 32.1 32.2 Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. Published online May 6, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32374370 https://jamanetwork.com/journals/jama/fullarticle/2765837
- ↑ 33.0 33.1 Li D, Jin M, Bao P et al Clinical Characteristics and Results of Semen Tests Among Men With Coronavirus Disease 2019. JAMA Netw Open. 2020;3(5):e208292 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32379329 Free full text https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2765654
- ↑ 34.0 34.1 Centers for Disease Control & Prevention (CDC) Overview of Testing for SARS-CoV-2 (COVID-19). Aug. 24, 2020 https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html
AMA Statement. August 26, 2020 AMA statement on CDC changes to COVID-19 testing guidance. https://www.ama-assn.org/press-center/ama-statements/ama-statement-cdc-changes-covid-19-testing-guidance - ↑ 35.0 35.1 Basu A, Zinger T, Inglima K et al Performance of the rapid Nucleic Acid Amplification by Abbott ID NOW COVID-19 in nasopharyngeal swabs transported in viral media and dry nasal swabs, in a New York City academic institution. bioRxiv. May 12, 2020 Not indexed in PubMed https://www.biorxiv.org/content/10.1101/2020.05.11.089896v1
Basu A, Zinger T, Inglima K et al Performance of Abbott ID Now COVID-19 Rapid Nucleic Acid Amplification Test Using Nasopharyngeal Swabs Transported in Viral Transport Media and Dry Nasal Swabs in a New York City Academic Institution. J Clin Microbiol. 2020 Jul 23;58(8):e01136-20 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32471894 PMCID: PMC7383552 Free PMC article - ↑ 36.0 36.1 36.2 Frieden J CMS Rule Requires Nursing Home Staff to be Tested for COVID-19 - Non-compliant facilities could face fines in excess of $400 per day MedPage Today August 26, 2020 https://www.medpagetoday.com/infectiousdisease/covid19/88285
- ↑ 37.0 37.1 McNamara D FDA Approves Point-of-Care COVID-19 Antigen Test. Medscape - Aug 27, 2020 https://www.medscape.com/viewarticle/936434
- ↑ 38.0 38.1 Wyllie AL, Fournier J, Casanovas-Massana A et al Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV- N Engl J Med. Aug 28, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32857487 https://www.nejm.org/doi/full/10.1056/NEJMc2016359
- ↑ 39.0 39.1 39.2 39.3 39.4 Sultan S, Altayar A, Siddique SM et al. AGA Institute rapid review of the GI and liver manifestations of COVID-19, meta-analysis of international data, and recommendations for the consultative management of patients with COVID-19. Gastroenterology. 2020 May 5. Review. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32407808 Free PMC Article https://www.gastrojournal.org/article/S0016-5085(20)30593-X/pdf
Stefanacci RG, RustgiVK. The Impact of COVID-19 on Liver Disease Management in Long-Term Care. Ann Longterm Care. 2020;28(2):e8-e11. https://www.managedhealthcareconnect.com/articles/impact-covid-19-liver-disease-management-long-term-care - ↑ Bryan A, Pepper G, Wener MH et al. Performance characteristics of the Abbott architect SARS-CoV-2 IgG assay and seroprevalence in Boise, Idaho. J Clin Microbiol 2020 May 7; PMID: https://www.ncbi.nlm.nih.gov/pubmed/32381641 https://jcm.asm.org/content/early/2020/05/07/JCM.00941-20
Theel ES, Siev P, Wheeler S et al. The role of antibody testing for SARS-CoV-2: Is there one? J Clin Microbiol 2020 Apr 29; PMID: https://www.ncbi.nlm.nih.gov/pubmed/32350047 Free article. - ↑ 41.0 41.1 Gibani MM, Toumazou C. Sohbati M et al Assessing a novel, lab-free, point-of-care test for SARS-CoV-2 (CovidNudge): a diagnostic accuracy study. The Lancet Microbe. Sept 17, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32964211 PMCID: PMC7498257 https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(20)30121-X/fulltext
- ↑ 42.0 42.1 Foy BH, Carlson JCT, Reinertsen E et al Association of Red Blood Cell Distribution Width With Mortality Risk in Hospitalized Adults With SARS-CoV-2 Infection. JAMA Netw Open. 2020;3(9):e2022058. Sept 23 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32965501 Free article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2770945
- ↑ 43.0 43.1 43.2 43.3 Rubin R Sorting Out Whether Vitamin D Deficiency Raises COVID-19 Risk. JAMA. Published online January 6, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33404587 https://jamanetwork.com/journals/jama/fullarticle/2775003
Maghbooli Z, Sahraian MA, Ebrahimi M et al Vitamin D sufficiency, a serum 25-hydroxyvitamin D at least 30 ng/mL reduced risk for adverse clinical outcomes in patients with COVID-19 infection. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32976513 PMCID: PMC7518605 Free PMC article PLOS One Published: September 25, 2020 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0239799
McCall B Vitamin D May Protect Against COVID-19, Especially in Blacks. Medscape - Mar 25, 2021. https://www.medscape.com/viewarticle/948110 - ↑ 44.0 44.1 Hanson KE et al. Self-collected anterior nasal and saliva specimens versus healthcare worker- collected nasopharyngeal swabs for the molecular detection of SARS-CoV-2. J Clin Microbiol 2020 Aug 12 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32817233 https://jcm.asm.org/content/early/2020/08/07/JCM.01824-20
- ↑ 45.0 45.1 Brendish NJ et al Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital (COV-19POC): a prospective, interventional, non-randomised, controlled study. Lancet Respir Med 2020 Oct 8, PMID: https://www.ncbi.nlm.nih.gov/pubmed/33038974 PMCID: PMC7544498 Free PMC article https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30454-9/fulltext
- ↑ 46.0 46.1 46.2 Shrock E, Fujimura E, Kula T et al Viral epitope profiling of COVID-19 patients reveals cross-reactivity and correlates of severity. Science 2020 Sep 29; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/32994364 https://science.sciencemag.org/content/early/2020/09/28/science.abd4250
- ↑ 47.0 47.1 47.2 Brandsma E et al. Rapid, sensitive and specific SARS coronavirus-2 detection: A multi-center comparison between standard qRT-PCR and CRISPR based DETECTR. J Infect Dis 2020 Oct 10; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/33038252 https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiaa641/5920647
- ↑ 48.0 48.1 FDA. Letters to Health Care Providers. Nov 3, 2020 Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers https://www.fda.gov/medical-devices/letters-health-care-providers/potential-false-positive-results-antigen-tests-rapid-detection-sars-cov-2-letter-clinical-laboratory
Centers for Disease Control & Prevention (CDC). Oct 23, 2020 Considerations for Use of SARS-CoV-2 Antigen Testing in Nursing Homes. https://www.cdc.gov/coronavirus/2019-ncov/hcp/nursing-homes-antigen-testing.html - ↑ 49.0 49.1 49.2 FDA News Release. Nov 6, 2020 Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-detects-neutralizing-antibodies-recent-or
- ↑ 50.0 50.1 Parasa S, Desai M, Chandrasekar VT et al Prevalence of Gastrointestinal Symptoms and Fecal Viral Shedding in Patients With Coronavirus Disease 2019. A Systematic Review and Meta-analysis. JAMA Netw Open. 2020;3(6):e2011335. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32525549 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2767009
- ↑ 51.0 51.1 Centers for Disease Control & Prevention (CDC) CDC releases consolidated COVID-19 testing recommendations. CDC Media Statement: June 13, 2020 https://www.cdc.gov/media/releases/2020/s0613-covid19-testing-recommendations.html
- ↑ 52.0 52.1 Walker M FDA OKs First Totally At-Home COVID-19 Diagnostic Test - Available by prescription, with results in 30 minutes or less, the agency says. https://www.medpagetoday.com/infectiousdisease/covid19/89759 Brooks M FDA Clears First Rapid At-Home COVID Test Medscape - Nov 18, 2020. https://www.medscape.com/viewarticle/941214
Coronavirus (COVID-19) Update. Nov 17, 2020 FDA Authorizes First COVID-19 Test for Self-Testing at Home https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home - ↑ 53.0 53.1 53.2 Higgins TS, Wu AW, Ting JY. SARS-CoV-2 Nasopharyngeal Swab Testing - False-Negative Results From a Pervasive Anatomical Misconception. JAMA Otolaryngol Head Neck Surg. 2020;146(11):993-994. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32940647 https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/10.1001/jamaoto.2020.2946
- ↑ 54.0 54.1 Davenport L COVID-19: Cortisol Levels on Admission Can Help Predict Severity. Medscape - Jun 22, 2020. https://www.medscape.com/viewarticle/932705
- ↑ 55.0 55.1 Andersson M et al Rapid roll out of SARS-CoV-2 antibody testing - a concern BMJ 2020;369:m2420 June 24. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32580928 https://www.bmj.com/content/369/bmj.m2420
Armstrong S Why covid-19 antibody tests are not the game changer the UK government claims. BMJ 2020;369:m2469 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32580936 https://www.bmj.com/content/369/bmj.m2469 - ↑ 56.0 56.1 56.2 Deeks JJ, Dinnes J, Takwoingi Y et al Antibody tests for identification of current and past infection with SARS-CoV-2 Cochrane Database of Systematic Reviews 2020, Issue 6. Art. No.: CD013652. 25 June. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32584464 https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013652/full
- ↑ 57.0 57.1 57.2 57.3 57.4 57.5 Cevik M, Tate M, Lloyd O et al SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis. The Lancet Microbe. 2020. Nov 19. Not indexed in PubMed https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(20)30172-5/fulltext
- ↑ 58.0 58.1 Walker M Semi-quantitative COVID-19 antibody testing kit. COVID-SeroKlir Medpage Today, Nov 30, 2020 https://www.medpagetoday.com/infectiousdisease/covid19/89904
Wajnberg A, Amanat F, Firpo A et al Robust neutralizing antibodies to SARS-CoV-2 infection persist for months Science 28 Oct 2020: PMID: https://www.ncbi.nlm.nih.gov/pubmed/33115920 https://science.sciencemag.org/content/early/2020/10/27/science.abd7728 - ↑ 59.0 59.1 Tucker ME Blood Glucose on Admission Predicts COVID-19 Severity in All. Medscape - Nov 30, 2020 https://www.medscape.com/viewarticle/941716
Carrasco-Sanchez FJ et al Admission hyperglycaemia as a predictor of mortality in patients hospitalized with COVID-19 regardless of diabetes status: data from the Spanish SEMI-COVID-19 Registry. Annals of Medicine 2021 53(1) PMID: https://www.ncbi.nlm.nih.gov/pubmed/33063540 PMCID: PMC7651248 Free PMC article https://www.tandfonline.com/doi/abs/10.1080/07853890.2020.1836566 - ↑ 60.0 60.1 Denny TN, Andrews L, Bonsignori M, et al. Implementation of a Pooled Surveillance Testing Program for Asymptomatic SARS-CoV-2 Infections on a College Campus - Duke University, Durham, North Carolina, August 2-October 11, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1743-1747 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33211678 PMCID: PMC7676642 Free PMC article https://www.cdc.gov/mmwr/volumes/69/wr/mm6946e1.htm
- ↑ 61.0 61.1 61.2 FDA News Release. Dec 4, 2020 Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-and-flu-combination-test-use-home
- ↑ 62.0 62.1 Self WH et al. Decline in SARS-CoV-2 antibodies after mild infection among frontline health care personnel in a multistate hospital network - 2 States, April- August 2020. MMWR Morb Mortal Wkly Rep 2020 Nov 27; 69:1762 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33237893 https://www.cdc.gov/mmwr/volumes/69/wr/mm6947a2.htm)
- ↑ 63.0 63.1 Alltucker K 'A major breakthrough': FDA authorizes nation's first at-home, over-the-counter COVID-19 test. USA Today. Dec 15, 2020 https://www.usatoday.com/story/news/health/2020/12/15/fda-authorizes-first-home-covid-19-test-ellume/3910420001/
FDA News Release. Dec 15, Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic
Ellume COVID-19 Home Test FDA Dec 15, 2020 https://www.fda.gov/media/144457/download
FDA Authorizes First OTC COVID-19 Test - Patient collects sample, smartphone app helps interpret results. MedPage Today December 15, 2020 https://www.medpagetoday.com/clinical-challenges/lung-cancer/89945 - ↑ 64.0 64.1 Lumley SF, O'Donnell D, Stoesser NE et al Antibody Status and Incidence of SARS-CoV-2 Infection in Health Care Workers. N Engl J Med 2020. Dec 23. PMID: https://www.ncbi.nlm.nih.gov/pubmed/33369366 https://www.nejm.org/doi/full/10.1056/NEJMoa2034545
- ↑ 65.0 65.1 65.2 Zacharioudakis IM, Prasad PJ, Zervou FN Association of SARS-CoV-2 Genomic Load with COVID-19 Patient Outcomes. Ann Am Thorac Soc. 2020 Oct 29 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33119425
- ↑ Sutter R, Hert L, De Marchis GM et al Serum neurofilament light chain levels in the intensive care unit: comparison between severely ill patients with and without COVID-19. Ann Neurol 2020. Dec 30 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33377539 https://onlinelibrary.wiley.com/doi/abs/10.1002/ana.26004
- ↑ 67.0 67.1 Brunk D FDA Warns About Risk for False Negatives From Curative COVID Test Medscape - Jan 05, 2021. https://www.medscape.com/viewarticle/943597
- ↑ 68.0 68.1 68.2 Pray IW, Ford L, Cole D et al. Performance of an Antigen-Based Test for Asymptomatic and Symptomatic SARS-CoV-2 Testing at Two University Campuses - Wisconsin, September- October 2020. MMWR Morb Mortal Wkly Rep 2021;69:1642-47 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33382679 Free article https://www.cdc.gov/mmwr/volumes/69/wr/mm695152a3.htm
- ↑ 69.0 69.1 Rathe JA, Hemann EA, Eggenberger J et al. SARS-CoV-2 serologic assays in control and unknown populations demonstrate the necessity of virus neutralization testing. J Infect Dis 2020 Dec 25; PMID: https://www.ncbi.nlm.nih.gov/pubmed/33367830 https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiaa797/6047577
- ↑ 70.0 70.1 Butler-Laporte G, Lawandi A, Schiller I Comparison of Saliva and Nasopharyngeal Swab Nucleic Acid Amplification Testing for Detection of SARS-CoV-2A Systematic Review and Meta-analysis. JAMA Intern Med. Published online January 15, 2021. PMID: https://www.ncbi.nlm.nih.gov/pubmed/33449069 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2775397
- ↑ 71.0 71.1 Prince-Guerra JL, Almendares O, Nolen LD, et al. Evaluation of Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 Infection at Two Community-Based Testing Sites - Pima County, Arizona, November 3-17, 2020. MMWR Morb Mortal Wkly Rep. ePub: 19 January 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33476316 Free article https://www.cdc.gov/mmwr/volumes/70/wr/mm7003e3.htm
- ↑ 72.0 72.1 72.2 Ellis R China Using Anal Swabs for Some COVID Testing. Medscape - Jan 28, 2021. https://www.medscape.com/viewarticle/944866
- ↑ 73.0 73.1 Kim MC et al Duration of Culturable SARS-CoV-2 in Hospitalized Patients with Covid-19. N Engl J Med 2021. Jan 27 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33503337 https://www.nejm.org/doi/full/10.1056/NEJMc2027040
- ↑ 74.0 74.1 Shuren J, Stenzel T Perspective. The FDA's Experience with Covid-19 Antibody Tests. N Engl J Med. Feb 13, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33605568 https://www.nejm.org/doi/full/10.1056/NEJMp2033687
- ↑ 75.0 75.1 Vashisht R, Patel A, Crews BO et al Age- and Sex-Associated Variations in the Sensitivity of Serological Tests Among Individuals Infected With SARS-CoV-2. JAMA Netw Open. 2021;4(2):e210337. Feb 12 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33576815 Free article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2776300
- ↑ 76.0 76.1 Mallapaty S How sewage could reveal true scale of coronavirus outbreak. Wastewater testing could also be used as an early-warning sign if the virus returns. Nature, NEWS 03 April 2020 https://www.nature.com/articles/d41586-020-00973-x
Fiore K As Indiana Reopens, One City Scans Sewage for Guidance. On the frontier of "wastewater epidemiology". MedPage Today May 7, 2020 https://www.medpagetoday.com/infectiousdisease/covid19/86352
Nattino G, Castiglioni S, Cereda D et al Association Between SARS-CoV-2 Viral Load in Wastewater and Reported Cases, Hospitalizations, and Vaccinations in Milan, March 2020 to November 2021. JAMA. Published online April 1, 2022 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35363259 https://jamanetwork.com/journals/jama/fullarticle/2790911 - ↑ 77.0 77.1 Azzolini C, Donati S, Premi E et al SARS-CoV-2 on Ocular Surfaces in a Cohort of Patients With COVID-19 From the Lombardy Region, Italy. JAMA Ophthalmol. Published online March 4, 2021. PMID: https://www.ncbi.nlm.nih.gov/pubmed/33662099 https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2777178
- ↑ 78.0 78.1 Reuters Staff Roche Launches COVID-19 Variant Test to Help Monitor Mutations Medscape - Mar 16, 2021. https://www.medscape.com/viewarticle/947526
- ↑ 79.0 79.1 U.S. Food & Drug Administration (FDA). March 30, 2021 SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests
- ↑ 80.0 80.1 Salk Institute Fast, portable test can diagnose COVID-19 and track variants. The field test, called NIRVANA, can simultaneously detect and sequence SARS-CoV-2, influenza and other viruses. Science News. March 31, 2021 https://www.sciencedaily.com/releases/2021/03/210331173739.htm
- ↑ Fiore L Common Hospital PCR Test Affected by Viral Variant. Cepheid Xpert joins three other tests for which B.1.1.7 can be problematic. MedPage Today April 5, 2021 https://www.medpagetoday.com/special-reports/exclusives/91941
- ↑ US Food & Drug Administration (FDA) SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests
- ↑ 83.0 83.1 83.2 Abassi J A Next-Generation Rapid, Accurate SARS-CoV-2 Antibody Test. JAMA. 2021;325(18):1825. May 11 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33974035 https://jamanetwork.com/journals/jama/fullarticle/2779848
- ↑ 84.0 84.1 Henley J Dogs can better detect Covid in humans than lateral flow tests, finds study. French trial shows dogs were able to detect presence of coronavirus with 97% accuracy. The Guardian. May 20, 2021 https://www.theguardian.com/lifeandstyle/2021/may/20/dogs-can-better-detect-covid-in-humans-than-lateral-flow-tests-finds-study
Polus S COVID-19 sniffing dogs being deployed in Massachusetts. The Hill July 15, 2021 https://thehill.com/homenews/state-watch/563212-covid-19-sniffing-dogs-being-deployed-in-massachusetts
Walker M Can Trained Dogs Sniff Out COVID-Positive Travelers? Randomized trial in Finland suggests dogs can detect virus in airline passengers. MedPage Today May 16, 2022 https://www.medpagetoday.com/infectiousdisease/covid19/98746 - ↑ 85.0 85.1 Li Y, Tong CH, Bare LA et al Assessment of the Association of Vitamin D Level With SARS-CoV-2 Seropositivity Among Working-Age Adults. JAMA Netw Open. 2021;4(5):e2111634 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34009346 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2779952
- ↑ 86.0 86.1 86.2 86.3 Melville NA Lower Testosterone in Men Tied to Severe COVID Cases. Medscape. May 27, 2021 https://www.medscape.com/viewarticle/951980
- ↑ 87.0 87.1 87.2 Bakkour S et al Minipool testing for SARS-CoV-2 RNA in United States blood donors. Transfusion. May 27, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34046906 https://onlinelibrary.wiley.com/doi/10.1111/trf.16511
- ↑ 88.0 88.1 Holmdahl I, Kahn R, Hay JA et al Estimation of Transmission of COVID-19 in Simulated Nursing Homes With Frequent Testing and Immunity-Based Staffing. JAMA Netw Open. 2021;4(5):e2110071. May 14 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33988707 PMCID: PMC8122229 Free PMC article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2779870
- ↑ 89.0 89.1 American Medical Association (AMA) AMA Morning Rounds. July 29, 2021 MorningRounds@ama.bulletinhealthcare.com
- ↑ 90.0 90.1 University of California, Berkeley Using two CRISPR enzymes, a COVID diagnostic in only 20 minutes. Eliminating initial RNA amplification simplifies and speeds up assay for SARS-CoV-2 virus. Science News. Aug 5, 2021 https://www.sciencedaily.com/releases/2021/08/210805133804.htm
- ↑ 91.0 91.1 91.2 Congrave-Wilson Z, Lee Y, Jumarang J et al. Change in saliva RT-PCR sensitivity over the course of SARS-CoV-2 infection. JAMA 2021 Aug 13; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/34387653 https://jamanetwork.com/journals/jama/fullarticle/2783249
- ↑ 92.0 92.1 92.2 Agarwal DP, Nandwanaa V, Henrich SE et al Highly sensitive and ultra-rapid antigen-based detection of SARS-CoV-2 using nanomechanical sensor platform. Biosens Bioelectron. 2021 Sep 17;195:113647 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34583103 PMCID: PMC8445766 Free PMC article https://www.sciencedirect.com/science/article/pii/S0956566321006849
- ↑ 93.0 93.1 93.2 Abassi J The Flawed Science of Antibody Testing for SARS-CoV-2 Immunity. JAMA. Published online October 21, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34673883 https://jamanetwork.com/journals/jama/fullarticle/2785530
- ↑ Logothetis CN, Weppelmann TA, Jordan A et al. D-dimer testing for the exclusion of pulmonary embolism among hospitalized patients with COVID-19. JAMA Netw Open 2021 Oct 8; 4:e2128802 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34623411 PMCID: PMC8501396 Free PMC article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784795
- ↑ 95.0 95.1 95.2 95.3 U.S. Food & Drug Administration. Dec 22, 2021 SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests
- ↑ 96.0 96.1 Gans JS, Goldfarb A, Agrawal AK et al False-Positive Results in Rapid Antigen Tests for SARS-CoV-2. JAMA. Published online January 7, 2022. PMID: https://www.ncbi.nlm.nih.gov/pubmed/34994775 https://jamanetwork.com/journals/jama/fullarticle/2788067
- ↑ 97.0 97.1 97.2 George J Brain Injury Biomarkers Elevated in Hospitalized COVID Patients. Some markers reach levels seen in dementia patients. MedPage Today January 14, 2022Can Trained Dogs Sniff Out COVID-Positive Travelers?Can Trained Dogs Sniff Out COVID-Positive Travelers?Can Trained Dogs Sniff Out COVID-Positive Travelers?Can Trained Dogs Sniff Out COVID-Positive Travelers?Can Trained Dogs Sniff Out COVIDCan Trained Dogs Sniff Out COVID https://www.medpagetoday.com/neurology/generalneurology/96699
Frontera JA, Boutajangout A, Masurkar AV et al Comparison of serum neurodegenerative biomarkers among hospitalized COVID-19 patients versus non-COVID subjects with normal cognition, mild cognitive impairment, or Alzheimer's dementia. Alzheimer's & Dementia. 2022. Jan 13 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35023610 https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.12556 - ↑ 98.0 98.1 American Medical Association AMA Morning Rounds. Jan 20, 2022
Luhby T Senior citizens are fuming that Medicare won't pay for Covid-19 tests at retailers. CNN. Jan 19, 2022 https://www.cnn.com/2022/01/19/politics/senior-citizens-medicare-free-covid-tests-retailers/index.html - ↑ 99.0 99.1 Henderson J I'm Over COVID Symptoms, but Still Testing Positive. Infectiousness may linger beyond the 5-day isolation period recommended by the CDC. MedPage Today January 20, 2022 https://www.medpagetoday.com/special-reports/exclusives/96765
- ↑ 100.0 100.1 100.2 Banada PP, Green R, Banik S et al An expanded high throughput RT-PCR assay to rapidly identify all known SARS-CoV-2 variants of concern using melting temperature coding. medRxiv Jan 21, 2022 https://www.medrxiv.org/content/10.1101/2022.01.18.22269424v1
- ↑ 101.0 101.1 Alejo JL, Mitchell J, Chang A et al. Prevalence and durability of SARS-CoV-2 antibodies among unvaccinated US adults by history of COVID-19. JAMA 2022 Feb 3; PMID: https://www.ncbi.nlm.nih.gov/pubmed/35113143 https://jamanetwork.com/journals/jama/fullarticle/2788894
- ↑ 102.0 102.1 Chu VT et al. Comparison of home antigen testing with RT-PCR and viral culture during the course of SARS-CoV-2 infection. JAMA Intern Med 2022 Apr 29; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/35486394 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2791915
- ↑ 103.0 103.1 103.2 Fiore K Can I Use My Expired At-Home COVID Tests?
No matter what, don't rely on results that don't make sense. MedPage Today June 28, 2022 https://www.medpagetoday.com/special-reports/features/99492 - ↑ 104.0 104.1 104.2 Schuit E et al. Diagnostic accuracy of covid-19 rapid antigen tests with unsupervised self-sampling in people with symptoms in the omicron period: Cross sectional study. BMJ 2022 Sep 14; 378:e071215. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36104069 PMCID: PMC9471225 Free PMC article https://www.bmj.com/content/378/bmj-2022-071215
- ↑ 105.0 105.1 Larkin H Combined COVID-19 and Flu Test Authorized for Point-of-Care Use. JAMA. 2023;329(1):14-15. doi:10.1001/jama.2022.23890. Jan 3. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36594962 https://jamanetwork.com/journals/jama/fullarticle/2800045
- ↑ 106.0 106.1 Bronze MS Fast Five Quiz: Influenza During the COVID-19 Pandemic. Medscape. Nov 15, 2022 https://reference.medscape.com/viewarticle/983770
- ↑ Food & Drug Administration (FDA) At-Home OTC COVID-19 Diagnostic Tests https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list
- ↑ 108.0 108.1 108.2 Deo R et al. Symptom and viral rebound in untreated SARS-CoV-2 infection. Ann Intern Med 2023 Feb 21; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36802755 https://www.acpjournals.org/doi/10.7326/M22-2381
- ↑ 109.0 109.1 Ghumra DP, Shetty N, McBrearty KR et al Rapid Direct Detection of SARS-CoV-2 Aerosols in Exhaled Breath at the Point of Care. ACS Sens. 2023, July 27 PMID: https://www.ncbi.nlm.nih.gov/pubmed/37498298 https://pubs.acs.org/doi/10.1021/acssensors.3c00512
- ↑ 110.0 110.1 Hessels LM et al. Procalcitonin-guided antibiotic prescription in patients with COVID-19: A multicenter observational cohort study. Chest 2023 Sep; 164:596. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37116748 PMCID: PMC10132833 Free PMC article https://journal.chestnet.org/article/S0012-3692(23)00633-5/fulltext
- ↑ 111.0 111.1 Frediani JK et l The New Normal: Delayed Peak SARS-CoV-2 Viral Loads Relative to Symptom Onset and Implications for COVID-19 Testing Programs. Clin Infect Dis. 2023 Sep 28:ciad582. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37768707