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Article ; Online: Testing for SARS-CoV-2: lessons learned and current use cases.

Theel, Elitza S / Kirby, James E / Pollock, Nira R

2024 , Page(s) e0007223

Abstract: SUMMARYThe emergence and worldwide dissemination of SARS-CoV-2 required both urgent development of new diagnostic tests and expansion of diagnostic testing capacity on an unprecedented scale. The rapid evolution of technologies that allowed testing to ... ...

Abstract	SUMMARYThe emergence and worldwide dissemination of SARS-CoV-2 required both urgent development of new diagnostic tests and expansion of diagnostic testing capacity on an unprecedented scale. The rapid evolution of technologies that allowed testing to move out of traditional laboratories and into point-of-care testing centers and the home transformed the diagnostic landscape. Four years later, with the end of the formal public health emergency but continued global circulation of the virus, it is important to take a fresh look at available SARS-CoV-2 testing technologies and consider how they should be used going forward. This review considers current use case scenarios for SARS-CoV-2 antigen, nucleic acid amplification, and immunologic tests, incorporating the latest evidence for analytical/clinical performance characteristics and advantages/limitations for each test type to inform current debates about how tests should or should not be used.
Language	English
Publishing date	2024-03-15
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	645015-5
ISSN	1098-6618 ; 0893-8512
ISSN (online)	1098-6618
ISSN	0893-8512
DOI	10.1128/cmr.00072-23
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Article: Detection of

Mesman, Annelies W / Calderon, Roger I / Hauns, Laura / Pollock, Nira R / Mendoza, Milagros / Holmberg, Rebecca C / Franke, Molly F

medRxiv : the preprint server for health sciences

2023

Abstract: Diagnosis of tuberculosis (TB) relies on a sputum sample, which cannot be obtained from all symptomatic patients. ...

Abstract	Diagnosis of tuberculosis (TB) relies on a sputum sample, which cannot be obtained from all symptomatic patients.
Language	English
Publishing date	2023-07-27
Publishing country	United States
Document type	Preprint
DOI	10.1101/2023.07.26.23293199
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Article ; Online: Similar SARS-CoV-2 Ct Value Distributions in Anterior Nares versus Nasopharyngeal Samples from Symptomatic Children during Delta and Omicron Surges.

Rattan, Ankit / Joerger, Jill / Williams, David / Pollock, Nira R

Journal of the Pediatric Infectious Diseases Society

2022 Volume 12, Issue 2, Page(s) 109–112

Abstract: In symptomatic children tested for COVID-19 by PCR during both Delta and Omicron surges, Cycle threshold value medians and distributions in anterior nares (AN) and nasopharyngeal (NP) samples were very similar, suggesting similar yield of NP and AN ... ...

Abstract	In symptomatic children tested for COVID-19 by PCR during both Delta and Omicron surges, Cycle threshold value medians and distributions in anterior nares (AN) and nasopharyngeal (NP) samples were very similar, suggesting similar yield of NP and AN sampling for SARS-CoV-2 PCR testing in symptomatic children.
MeSH term(s)	Humans ; Child ; SARS-CoV-2 ; COVID-19 ; Polymerase Chain Reaction
Language	English
Publishing date	2022-12-05
Publishing country	England
Document type	Journal Article
ZDB-ID	2668791-4
ISSN	2048-7207 ; 2048-7193
ISSN (online)	2048-7207
ISSN	2048-7193
DOI	10.1093/jpids/piac130
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Article ; Online: Ultrasensitive Detection and Quantification of Toxins for Optimized Diagnosis of Clostridium difficile Infection.

Pollock, Nira R

Journal of clinical microbiology

2015 Volume 54, Issue 2, Page(s) 259–264

Abstract: Recently developed ultrasensitive and quantitative methods for detection of Clostridium difficile toxins provide new tools for diagnosis and, potentially, for management of C. difficile infection (CDI). Compared to methods that detect toxigenic organism, ...

Abstract	Recently developed ultrasensitive and quantitative methods for detection of Clostridium difficile toxins provide new tools for diagnosis and, potentially, for management of C. difficile infection (CDI). Compared to methods that detect toxigenic organism, ultrasensitive toxin detection may allow diagnosis of CDI with increased clinical specificity, without sacrificing clinical sensitivity; measurement of toxin levels may also provide information relevant to disease prognosis. This minireview provides an overview of these new toxin detection technologies and considers what these new tools might add to the field.
MeSH term(s)	Bacterial Toxins/metabolism ; Clostridium difficile/metabolism ; Enterocolitis, Pseudomembranous/diagnosis ; Enterocolitis, Pseudomembranous/microbiology ; Enterotoxins/metabolism ; Humans ; Immunoenzyme Techniques/methods ; Immunoenzyme Techniques/standards ; Sensitivity and Specificity
Chemical Substances	Bacterial Toxins ; Enterotoxins
Language	English
Publishing date	2015-12-09
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.02419-15
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Article ; Online: Pediatric Clostridioides difficile Infection: Diagnosis and Diagnostic Stewardship.

Schwenk, Hayden T / Pollock, Nira R / Vaughan-Malloy, Ana M

Journal of the Pediatric Infectious Diseases Society

2021 Volume 10, Issue Supplement_3, Page(s) S16–S21

Abstract: Although the pathogenesis of Clostridioides difficile infection (CDI) is complex and incompletely understood, it is believed that the elaboration of C. difficile toxins is necessary for disease. There are a variety of tests available for the detection of ...

Abstract	Although the pathogenesis of Clostridioides difficile infection (CDI) is complex and incompletely understood, it is believed that the elaboration of C. difficile toxins is necessary for disease. There are a variety of tests available for the detection of both the C. difficile organism and its toxins; however, each has limitations and the best application of these tests to the diagnosis of CDI in children remains uncertain. Nucleic acid amplification tests are unable to reliably discriminate between CDI and C. difficile colonization, while commercially available enzyme immunoassays for toxin detection lack sensitivity. An understanding of preanalytic factors, relevant patient features, and test performance characteristics is essential to the accurate diagnosis of CDI in children. Specific diagnostic stewardship strategies can also increase the likelihood that positive tests reflect disease rather than colonization. Ultimately, CDI remains a clinical diagnosis and clinical judgment is essential when interpreting test results, regardless of the methods used.
MeSH term(s)	Bacterial Proteins ; Bacterial Toxins ; Child ; Clostridioides ; Clostridioides difficile ; Clostridium Infections/diagnosis ; Feces ; Humans
Chemical Substances	Bacterial Proteins ; Bacterial Toxins
Language	English
Publishing date	2021-11-13
Publishing country	England
Document type	Journal Article
ZDB-ID	2668791-4
ISSN	2048-7207 ; 2048-7193
ISSN (online)	2048-7207
ISSN	2048-7193
DOI	10.1093/jpids/piab054
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Article ; Online: Evaluation of "Test to Return" after COVID-19 Diagnosis in a Massachusetts Public School District.

Nelson, Sandra B / Brenner, Isaac Ravi / Homan, Elizabeth / Lee, Sarah Bott / Bongiorno, Christine / Pollock, Nira R / Ciaranello, Andrea

The Journal of school health

2023 Volume 93, Issue 10, Page(s) 877–882

Abstract: Background: Per Centers for Disease Control and Prevention guidance, students with COVID-19 may end isolation after 5 days if symptoms are improving; some individuals may still be contagious. Rapid antigen testing identifies possibly infectious virus. ... ...

Abstract	Background: Per Centers for Disease Control and Prevention guidance, students with COVID-19 may end isolation after 5 days if symptoms are improving; some individuals may still be contagious. Rapid antigen testing identifies possibly infectious virus. We report on a test-to-return (TTR) program in a Massachusetts school district to inform policy decisions about return to school after COVID-19. Methods: During the 2021-2022 Omicron BA.1 surge, students with COVID-19 could return on day 6-10 if they met symptom criteria and had a negative rapid test; students with positive rapid tests and those who declined TTR remained isolated until day 11. TTR positivity rates were compared by grade level, vaccination status, symptom status, and day of infection. Results: 31.4% of students had a positive TTR rapid test; there were no differences by grade or vaccination status. Ever-symptomatic students were more likely to have a positive rapid test (75/174 [43.1%] vs 18/104 [17.3%]). For ever-symptomatic students, TTR positivity decreased by day of infection. Conclusions: A substantial proportion of students may still be contagious 6 days after onset of COVID-19 infection. TTR programs may increase or reduce missed school days, depending on when return is otherwise allowed (day 6 or 11). The impact of TTR programs on school-associated transmission remains unknown.
MeSH term(s)	Humans ; COVID-19/diagnosis ; COVID-19/epidemiology ; COVID-19 Testing ; Schools ; Massachusetts/epidemiology ; Students
Language	English
Publishing date	2023-06-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	952835-0
ISSN	1746-1561 ; 0022-4391
ISSN (online)	1746-1561
ISSN	0022-4391
DOI	10.1111/josh.13357
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Article: The New Normal: Delayed Peak SARS-CoV-2 Viral Loads Relative to Symptom Onset and Implications for COVID-19 Testing Programs.

Frediani, Jennifer K / Parsons, Richard / McLendon, Kaleb B / Westbrook, Adrianna L / Lam, Wilbur / Martin, Greg / Pollock, Nira R

medRxiv : the preprint server for health sciences

2023

Abstract: Background: Early in the COVID-19 pandemic, peak viral loads coincided with symptom onset. We hypothesized that in a highly immune population, symptom onset might occur earlier in infection, coinciding with lower viral loads.: Methods: We assessed ... ...

Abstract	Background: Early in the COVID-19 pandemic, peak viral loads coincided with symptom onset. We hypothesized that in a highly immune population, symptom onset might occur earlier in infection, coinciding with lower viral loads. Methods: We assessed SARS-CoV-2 and influenza A viral loads relative to symptom duration in recently-tested adults. Symptomatic participants ≥16y presenting to testing sites in Georgia (4/2022-4/2023; Omicron variant predominant) provided symptom duration. Nasal swab samples were tested by the Xpert Xpress SARS-CoV-2/Flu/RSV assay and Ct values recorded. Nucleoprotein concentrations in SARS-CoV-2 PCR-positive samples were measured by Single Molecule Array. To estimate hypothetical antigen rapid diagnostic test (Ag RDT) sensitivity on each day after symptom onset, percentages of individuals with Ct value ≤30 or ≤25 were calculated. Results: Of 621 SARS-CoV-2 PCR-positive individuals (64.1% women, median 40.9y), 556/621 (89.5%) had a history of vaccination, natural infection, or both. By both Ct value and antigen concentration measurements, median viral loads rose from the day of symptom onset and peaked on the fourth day. Ag RDT sensitivity estimates were 35.7-71.4% on the first day, 63.9-78.7% on the third day, and 78.6-90.6% on the fourth day of symptoms.In 74 influenza A PCR-positive individuals (55.4% women; median 35.0y), median influenza viral loads peaked on the second day of symptoms. Conclusions: In a highly immune adult population, median SARS-CoV-2 viral loads peaked on the fourth day of symptoms. Influenza A viral loads peaked soon after symptom onset. These findings have implications for ongoing use of Ag RDTs for COVID-19 and influenza. Key points: In a highly immune adult population, median SARS-CoV-2 viral loads by cycle threshold and antigen measurements peaked on the fourth day of symptoms, with implications for testing practice. In contrast, viral loads for influenza A peaked soon after symptom onset.
Language	English
Publishing date	2023-05-10
Publishing country	United States
Document type	Preprint
DOI	10.1101/2023.05.09.23289735
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Article ; Online: The New Normal: Delayed Peak SARS-CoV-2 Viral Loads Relative to Symptom Onset and Implications for COVID-19 Testing Programs.

Frediani, Jennifer K / Parsons, Richard / McLendon, Kaleb B / Westbrook, Adrianna L / Lam, Wilbur / Martin, Greg / Pollock, Nira R

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2023 Volume 78, Issue 2, Page(s) 301–307

Abstract: Background: Early in the coronavirus disease 2019 (COVID-19) pandemic, peak viral loads coincided with symptom onset. We hypothesized that in a highly immune population, symptom onset might occur earlier in infection, coinciding with lower viral loads.!# ...

Abstract	Background: Early in the coronavirus disease 2019 (COVID-19) pandemic, peak viral loads coincided with symptom onset. We hypothesized that in a highly immune population, symptom onset might occur earlier in infection, coinciding with lower viral loads. Methods: We assessed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A viral loads relative to symptom duration in symptomatic adults (≥16 years) presenting for testing in Georgia (4/2022-4/2023; Omicron variant predominant). Participants provided symptom duration and recent testing history. Nasal swabs were tested by Xpert Xpress SARS-CoV-2/Flu/RSV assay and cycle threshold (Ct) values recorded. Nucleoprotein concentrations in SARS-CoV-2 polymerase chain reaction (PCR)-positive samples were measured by single molecule array. To estimate hypothetical antigen rapid diagnostic test (Ag RDT) sensitivity on each day after symptom onset, percentages of individuals with Ct value ≤30 or ≤25 were calculated. Results: Of 348 newly-diagnosed SARS-CoV-2 PCR-positive individuals (65.5% women, median 39.2 years), 317/348 (91.1%) had a history of vaccination, natural infection, or both. By both Ct value and antigen concentration measurements, median viral loads rose from the day of symptom onset and peaked on the fourth/fifth day. Ag RDT sensitivity estimates were 30.0%-60.0% on the first day, 59.2%-74.8% on the third day, and 80.0%-93.3% on the fourth day of symptoms.In 74 influenza A PCR-positive individuals (55.4% women; median 35.0 years), median influenza viral loads peaked on the second day of symptoms. Conclusions: In a highly immune adult population, median SARS-CoV-2 viral loads peaked around the fourth day of symptoms. Influenza A viral loads peaked soon after symptom onset. These findings have implications for ongoing use of Ag RDTs for COVID-19 and influenza.
MeSH term(s)	Adult ; Female ; Humans ; Male ; SARS-CoV-2 ; COVID-19/diagnosis ; COVID-19 Testing ; Influenza, Human/diagnosis ; Influenza, Human/epidemiology ; Viral Load ; Influenza A virus ; Sensitivity and Specificity
Language	English
Publishing date	2023-09-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciad582
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Article ; Online: Prevalence and Risk Factors for School-Associated Transmission of SARS-CoV-2.

Nelson, Sandra B / Dugdale, Caitlin M / Brenner, Isaac Ravi / Crawford, Allison / Bilinski, Alyssa / Cosar, Duru / Pollock, Nira R / Ciaranello, Andrea

JAMA health forum

2023 Volume 4, Issue 8, Page(s) e232310

Abstract: Importance: School-associated SARS-CoV-2 transmission is described as uncommon, although the true transmission rate is unknown.: Objective: To identify the SARS-CoV-2 secondary attack rate (SAR) in schools and factors associated with transmission.: ...

Abstract	Importance: School-associated SARS-CoV-2 transmission is described as uncommon, although the true transmission rate is unknown. Objective: To identify the SARS-CoV-2 secondary attack rate (SAR) in schools and factors associated with transmission. Design, setting, and participants: This cohort study examined the risk of school-based transmission of SARS-CoV-2 among kindergarten through grade 12 students and staff in 10 Massachusetts school districts during 2 periods: fall 2020/spring 2021 (F20/S21) and fall 2021 (F21). School staff collected data on SARS-CoV-2 index cases and school-based contacts, and SAR was defined as the proportion of contacts acquiring SARS-CoV-2 infection. Exposure: SARS-CoV-2. Main outcomes and measures: Potential factors associated with transmission, including grade level, masking, exposure location, vaccination history, and Social Vulnerability Index (SVI), were analyzed using univariable and multivariable logistic regression models. Results: For F20/S21, 8 school districts (70 schools, >33 000 students) were included and reported 435 index cases (151 staff, 216 students, and 68 missing role) with 1771 school-based contacts (278 staff, 1492 students, and 1 missing role). For F21, 5 districts (34 schools, >18 000 students) participated and reported 309 index cases (37 staff, 207 students, and 65 missing role) with 1673 school-based contacts (107 staff and 1566 students). The F20/S21 SAR was 2.2% (lower bound, 1.6%; upper bound, 26.7%), and the F21 SAR was 2.8% (lower bound, 2.6%; upper bound, 7.4%). In multivariable analysis, during F20/S21, masking was associated with a lower odds of transmission compared with not masking (odds radio [OR], 0.12; 95% CI, 0.04-0.40; P < .001). In F21, classroom exposure vs out-of-classroom exposure was associated with increased odds of transmission (OR, 2.47; 95% CI, 1.07-5.66; P = .02); a fully vaccinated vs unvaccinated contact was associated with a lower odds of transmission (OR, 0.04; 95% CI, 0.00-0.62; P < .001). In both periods, a higher SVI was associated with a greater odds of transmission. Conclusions and relevance: In this study of Massachusetts schools, the SAR for SARS-CoV-2 among school-based contacts was low during 2 periods, and factors associated with transmission risk varied over time. These findings suggest that ongoing surveillance efforts may be essential to ensure that both targeted resources and mitigation practices remain optimal and relevant for disease prevention.
MeSH term(s)	Humans ; SARS-CoV-2 ; Prevalence ; COVID-19/epidemiology ; Cohort Studies ; Risk Factors
Language	English
Publishing date	2023-08-04
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2689-0186
ISSN (online)	2689-0186
DOI	10.1001/jamahealthforum.2023.2310
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Article ; Online: Evaluating Novel Diagnostics in an Outbreak Setting: Lessons Learned from Ebola.

Pollock, Nira R / Wonderly, Betsy

Journal of clinical microbiology

2017 Volume 55, Issue 5, Page(s) 1255–1261

Abstract: Inadequate access to rapid testing for Ebola virus disease during the 2014-to-2016 outbreak led to an explosion in the development of diagnostics that could be performed at or near the point of care and by less-experienced operators, leading in turn to ... ...

Abstract	Inadequate access to rapid testing for Ebola virus disease during the 2014-to-2016 outbreak led to an explosion in the development of diagnostics that could be performed at or near the point of care and by less-experienced operators, leading in turn to an acute need for novel test evaluation. Here, we present the challenges to development and evaluation of novel diagnostics in an emergency setting and suggestions for potential new "global emergency standards" to address them.
MeSH term(s)	Africa, Western/epidemiology ; Disease Outbreaks ; Hemorrhagic Fever, Ebola/diagnosis ; Hemorrhagic Fever, Ebola/epidemiology ; Hemorrhagic Fever, Ebola/virology ; Humans ; Point-of-Care Systems
Language	English
Publishing date	2017-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.00053-17
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