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Accuracy of diagnostic tests for detection of infection with SARS CoV-2

https://covid19evidencereviews.saskhealthauthority.ca/en/permalink/coviddoc76
Document Type
Rapid Review
Review Code
EPM051201 RR
Question Submitted
May 12, 2020
Date Completed
May 12, 2020
Status
3. Completed
Research Team
Epidemiology & Modelling
., 2020). Conclusions Diagnostics are pivotal for early identification of individuals who
More detail
Document Type
Rapid Review
Review Code
EPM051201 RR
Question Submitted
May 12, 2020
Date Completed
May 12, 2020
Status
3. Completed
Research Team
Epidemiology & Modelling
Key Findings
·      A wide range of tests are available for detection of viral RNA as well as serological and immunoassays for antibodies developed due to exposure to SARS CoV-2 in infected persons. Despite the emerging research, information about clinical validity of tests is limited. ·      Multiple factors affect test performance including the nature of the specific test, type of specimen and its quality, severity and duration of illness at the time of testing. These individual variations hamper assessment of diagnostic accuracy and suggest that a combination of tests on multiple types of specimens at serial time points might be needed to confirm a COVID 19 diagnosis. ·      Point of care tests are desirable and needed to scale up testing in low resource settings; however, tests are of variable quality and more research is needed before they can be relied on for clinical decision making.
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Category
Diagnostics
Subject
Antigens
Testing
Serology
Polymerase Chain Reaction
Priority Level
Level 4 completed within 1 week
Cite As
Williams-Roberts, H; Waldener, C. What is the accuracy of diagnostic tests for COVID-19 detection? 2020 May 12; Document no.: EPM051201 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. (CEST rapid review report)
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How effective is surveillance antigenic testing?

https://covid19evidencereviews.saskhealthauthority.ca/en/permalink/coviddoc256
Document Type
Evidence Search Report
Review Code
EOC012601-01 ESR
Question Submitted
January 26, 2021
Date Completed
January 29, 2021
Status
3. Completed
Research Team
EOC
standard PCR diagnostics, especially against comparable test populations such as the national Pillar 2
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Document Type
Evidence Search Report
Review Code
EOC012601-01 ESR
Question Submitted
January 26, 2021
Date Completed
January 29, 2021
Status
3. Completed
Research Team
EOC
Category
Diagnostics
Infection Prevention and Control
Subject
Screening
Antigens
Asymptomatic
Testing
Priority Level
Level 3 Two weeks (14 days)
Cite As
Dalidowicz, M; Young, C. How effective is surveillance antigenic testing? 2021 Jan 29; Document no.: EOC012601-01 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 32 p. (CEST evidence search report).
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How effective is surveillance antigenic testing?

https://covid19evidencereviews.saskhealthauthority.ca/en/permalink/coviddoc263
Document Type
Rapid Review
Review Code
EOC012601 RR
Question Submitted
January 26, 2021
Date Completed
February 12, 2021
Status
3. Completed
Research Team
EOC
) 14 Patients with COVID-19 coronavirus 2 (SARS-CoV- 2) assay (Credo Diagnostics, Singapore
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Document Type
Rapid Review
Review Code
EOC012601 RR
Question Submitted
January 26, 2021
Date Completed
February 12, 2021
Status
3. Completed
Research Team
EOC
Key Findings
· Studies suggest that antigen-based rapid diagnostic tests (Ag-RDTs) can be used in a population level with high prevalence of COVID-19 disease where health systems are overwhelmed or where nucleic acid amplification tests (NAATs) such as real time reverse transcription polymerase chain reaction (rRT-PCR) are not available. · The Canadian COVID-19 Testing and Screening Expert Advisory Panel recommends the use of frequent screening with rapid diagnostic tests in selected groups to limit outbreaks. · WHO and European Center for Disease Prevention and Control recommend using Ag-RDTs with high sensitivity and specificity when NAATs are not available or turnaround time negatively affects NAATs’ clinical utility. For example, COVID-19 Ag-RDTs can be used to surveil health care workers or residents of congregate dwellings during outbreaks or when community transmission rates are high, to screen at-risk individuals to support outbreak investigations, or to screen suspected COVID-19 outbreaks in early stages in settings where NAATs are not available. · WHO does not recommend Ag-RDTs usage when expected prevalence is low (e.g., screening at points of entry) unless an Ag-RDT’s specificity is high (>99%). · Studies have shown that Panbio™ COVID-19 Ag Test (Abbott) can have overall sensitivity of 72.6% to 95.2% and specificity of 98.0% to 100% and suggest that this test is appropriate for contagious case identification and asymptomatic case screening, especially in high prevalence (>5%) settings. · WHO recommends that iterative Ag-RDT testing or confirmatory rRT-PCR testing be done in symptomatic patients or asymptomatic contacts of COVID-19 cases since a negative Ag-RDT result cannot completely exclude an active COVID-19 infection. · Challenges of population level testing (whether they succeed or fail) such as required logistics and resources (e.g., immunizers, access to Ag-RDTs and equipment), performance accuracy of Ag-RDTs (e.g., false positive or negative rates in real world settings), and public trust and engagement in testing and future measures (e.g., vaccine uptake) are yet to be considered.
Category
Diagnostics
Infection Prevention and Control
Subject
Antigens
Asymptomatic
Screening
Priority Level
Level 3 Two weeks (14 days)
Cite As
Azizian, A; Groot, G; Reeder, B; Hamula, C; Dalidowicz, M; Young, C. How effective is surveillance antigenic testing? 2021 Feb 12; Document no.: EOC012601 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 32 p. (CEST rapid review report)
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In real world settings, what is the validity of Rapid Antigen Tests (RATs) in identifying SARS-CoV-2 and how well do they predict disease?

https://covid19evidencereviews.saskhealthauthority.ca/en/permalink/coviddoc420
Document Type
Table
Review Code
EOC211201 RR Table
Question Submitted
December 23, 2021
Date Completed
January 12, 2022
Status
3. Completed
Research Team
EOC
, Katzenschlager S, Gaeddert M, et al. Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living
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Document Type
Table
Review Code
EOC211201 RR Table
Question Submitted
December 23, 2021
Date Completed
January 12, 2022
Status
3. Completed
Research Team
EOC
Category
Diagnostics
Epidemiology
Subject
Antigens
Infection Prevention and Control
Testing
Population
All
Clinical Setting
Public Health
Priority Level
Level 2 One week (7 days)
Cite As
Badea, A; Reeder, B; Groot, G; Muhajarine, N; Minion, J; Miller, L; Howell-Spooner, B. In real world settings, what is the validity of Rapid Antigen Tests (RATs) in identifying SARS-CoV-2 and how well do they predict disease? 2022 Jan 12, Document no.: EOC211201 RR Table. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2022. (CEST table).
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In real world settings, what is the validity of Rapid Antigen Tests (RATs) in identifying SARS-CoV-2 and how well do they predict disease?

https://covid19evidencereviews.saskhealthauthority.ca/en/permalink/coviddoc421
Document Type
Rapid Review
Review Code
EOC211201 RR
Question Submitted
December 23, 2021
Date Completed
January 12, 2022
Status
3. Completed
Research Team
EOC
/2021.11.03.21265807v1 3. Brummer LE, Katzenschlager S, Gaeddert M, et al. Accuracy of novel antigen rapid diagnostics
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Document Type
Rapid Review
Review Code
EOC211201 RR
Question Submitted
December 23, 2021
Date Completed
January 12, 2022
Status
3. Completed
Research Team
EOC
Key Findings
January 12, 2022
The diagnostic accuracy of Rapid Antigen Tests (RAT) has been widely studied in various applications and in diverse populations.
Sensitivity, in the order of 75% in pooled estimates, is significantly influenced by the presence or absence of symptoms, viral load, and the timing of sampling relative to the onset of symptoms.
Specificity, in the order of 99% in pooled estimates, is consistently high across tests, populations, and sampling methods.
Post-test probability of being an infectious case following a positive test is highest in individuals with a high pre-test probability (population prevalence > 5%), such as those with COVID-19 symptoms, and those in settings with a high level of community transmission. Here, the positive predictive value is in the order of 95%. However, when used in settings with a lower pre-test probability (population prevalence < 0.5%), as in screening asymptomatic individuals, the positive predictive value is considerably reduced, as low as 25%.
Post-test probability of being an infectious case following a negative test is less than 1% (negative predictive value > 99%) in all settings except those with the highest levels of community transmission.
Category
Diagnostics
Epidemiology
Subject
Antigens
Infection Prevention and Control
Testing
Population
All
Clinical Setting
Public Health
Priority Level
Level 2 One week (7 days)
Cite As
Badea, A; Reeder, B; Groot, G; Muhajarine, N; Minion, J; Miller, L; Howell-Spooner, B. In real world settings, what is the validity of Rapid Antigen Tests (RATs) in identifying SARS-CoV-2 and how well do they predict disease? 2022 Jan 12, Document no.: EOC211201 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2022. 15 p. (CEST rapid review report).
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In real world settings, what is the validity of RATs in identifying COVID-19 (sensitivity, specificity), and how well do they predict disease (positive and negative predictive values)?

https://covid19evidencereviews.saskhealthauthority.ca/en/permalink/coviddoc416
Document Type
Evidence Search Report
Review Code
EOC211201 ESR
Question Submitted
December 23, 2021
Date Completed
December 29, 2021
Status
3. Completed
Research Team
EOC
-COVID19-diagnostics-report-v2.6.pdf CADTH  Rapid Point-of-Care Testing for COVID-19. December 18
More detail
Document Type
Evidence Search Report
Review Code
EOC211201 ESR
Question Submitted
December 23, 2021
Date Completed
December 29, 2021
Status
3. Completed
Research Team
EOC
Category
Diagnostics
Epidemiology
Subject
Antigens
Infection Prevention and Control
Testing
Population
All
Clinical Setting
Public Health
Priority Level
Level 2 One week (7 days)
Cite As
Miller, L. & Howell-Spooner, B. In real world settings, what is the validity of RATs in identifying COVID-19 (sensitivity, specificity), and how well do they predict disease (positive and negative predictive values)? 2021 Dec 29, Document no.: EOC211201 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2021. 56 p. (CEST evidence search report).
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Is pooled testing for COVID-19 equally as reliable as individual testing and what are the optimal pool testing sizes?

https://covid19evidencereviews.saskhealthauthority.ca/en/permalink/coviddoc147
Document Type
Evidence Search Report
Review Code
EOC081301-01 ESR
Question Submitted
August 12, 2020
Date Completed
August 12, 2020
Status
3. Completed
Research Team
EOC
More detail
Document Type
Evidence Search Report
Review Code
EOC081301-01 ESR
Question Submitted
August 12, 2020
Date Completed
August 12, 2020
Status
3. Completed
Research Team
EOC
Category
Diagnostics
Subject
Testing
Public Health
Decision Making
Priority Level
Level 3 completed within 2-3 days
Cite As
Dalidowicz, M. Is pooled testing for COVID-19 equally as reliable as individual testing and what are the optimal pool testing sizes? 2020 Aug 12; Document no.: EOC081301-01 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 8 p. (CEST evidence search report)
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Is pooled testing for COVID-19 equally as reliable as individual testing and what are the optimal pool testing sizes?

https://covid19evidencereviews.saskhealthauthority.ca/en/permalink/coviddoc151
Document Type
Rapid Review
Review Code
EOC081301 RR
Question Submitted
August 12, 2020
Date Completed
August 14, 2020
Status
3. Completed
Research Team
EOC
More detail
Document Type
Rapid Review
Review Code
EOC081301 RR
Question Submitted
August 12, 2020
Date Completed
August 14, 2020
Status
3. Completed
Research Team
EOC
Key Findings
· Pool testing for COVID-19 can be equal to individual testing in terms of sensitivity, specificity and positive and negative prediction rates · Pooled testing is optimal for use when disease prevalence is low, as prevalence increases, optimal pool sizes decrease and efficiency is lost · At a prevalence of approximately 1%, optimal pool sizes have been found to be up to 13 · Pools of 5 were found to be equally efficient and could be done using 50% less tests up to a prevalence of 5% · Recommended for use in large scale asymptomatic screening, highest viral load occurs before symptoms so less likely to miss borderline positive in convalescent stage · Not recommended for clinical diagnostic use
Category
Diagnostics
Subject
Testing
Public Health
Decision Making
Priority Level
Level 3 completed within 2-3 days
Cite As
Badea, A; Muhajarine, N; Dalidowicz, M. Is pooled testing for COVID-19 equally as reliable as individual testing and what are the optimal pool testing sizes? 2020 Aug 14; Document no.: EOC081301 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 19 p. (CEST rapid review report)
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Omicron Variant: In real world settings, what is the validity of RATs in identifying COVID-19 (sensitivity, specificity), and how well do they predict disease (positive and negative predictive values)?

https://covid19evidencereviews.saskhealthauthority.ca/en/permalink/coviddoc418
Document Type
Evidence Search Report
Review Code
EOC211201-02 ESR
Question Submitted
December 23, 2021
Date Completed
January 5, 2022
Status
3. Completed
Research Team
EOC
December 2021. https://www.abbott.com/corpnewsroom/diagnostics-testing/an-update-on-omicron-and-test
More detail
Document Type
Evidence Search Report
Review Code
EOC211201-02 ESR
Question Submitted
December 23, 2021
Date Completed
January 5, 2022
Status
3. Completed
Research Team
EOC
Category
Diagnostics
Epidemiology
Subject
Antigens
Infection Prevention and Control
Testing
Variants
Population
All
Clinical Setting
Public Health
Priority Level
Level 2 One week (7 days)
Cite As
Miller, Lukas. Howell-Spooner, Brianna. Omicron Variant: In real world settings, what is the validity of RATs in identifying COVID-19 (sensitivity, specificity), and how well do they predict disease (positive and negative predictive values)? 2022 Jan 05. Document no.: EOC211201-02 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2022. 12 p. (CEST rapid review report).
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Testing for antigens/rapid tests for SARS-CoV2 and test performance (sensitivity and specificity)

https://covid19evidencereviews.saskhealthauthority.ca/en/permalink/coviddoc136
Document Type
Table
Review Code
EPM072101 RR Table
Question Submitted
July 21, 2020
Date Completed
July 21, 2020
Status
3. Completed
Research Team
Epidemiology & Modelling
Diagnostics, Toronto, Canada) Molecular diagnostic test 214 nucleic acid extracts of suspected COVID -19
More detail
Document Type
Table
Review Code
EPM072101 RR Table
Question Submitted
July 21, 2020
Date Completed
July 21, 2020
Status
3. Completed
Research Team
Epidemiology & Modelling
Category
Diagnostics
Subject
Antigens
Testing
Serology
Polymerase Chain Reaction
Priority Level
Level 2 completed within 8 hours
Cite As
Williams-Roberts, H; Waldner, C; Dalidowicz, M; Howell-Spooner, B. What is the accuracy of diagnostic tests for the detection of SARS-CoV-2? 2020 Jul 23; Document no.: EPM072101 RR Table. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. (CEST table)
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36 records – page 1 of 4.