Analytical Sensitivity and Specificity of Four Point of Care Rapid Antigen Diagnostic Tests for SARS-CoV-2 Using Real-Time Quantitative PCR, Quantitative Droplet Digital PCR, and a Mass Spectrometric Antigen Assay as Comparator Methods
© American Association for Clinical Chemistry 2021. All rights reserved. For permissions, please email: journals.permissionsoup.com..
BACKGROUND: We evaluated the analytical sensitivity and specificity of 4 rapid antigen diagnostic tests (Ag RDTs) for severe acute respiratory syndrome coronavirus 2, using reverse transcription quantitative PCR (RT-qPCR) as the reference method and further characterizing samples using droplet digital quantitative PCR (ddPCR) and a mass spectrometric antigen test.
METHODS: Three hundred fifty (150 negative and 200 RT-qPCR positive) residual PBS samples were tested for antigen using the BD Veritor lateral flow (LF), ACON LF, ACON fluorescence immunoassay (FIA), and LumiraDx FIA. ddPCR was performed on RT-qPCR-positive samples to quantitate the viral load in copies/mL applied to each Ag RDT. Mass spectrometric antigen testing was performed on PBS samples to obtain a set of RT-qPCR-positive, antigen-positive samples for further analysis.
RESULTS: All Ag RDTs had nearly 100% specificity compared to RT-qPCR. Overall analytical sensitivity varied from 66.5% to 88.3%. All methods detected antigen in samples with viral load >1 500 000 copies/mL RNA, and detected ≥75% of samples with viral load of 500 000 to 1 500 000 copies/mL. The BD Veritor LF detected only 25% of samples with viral load between 50 000 to 500 000 copies/mL, compared to 75% for the ACON LF device and >80% for LumiraDx and ACON FIA. The ACON FIA detected significantly more samples with viral load <50 000 copies/mL compared to the BD Veritor. Among samples with detectable antigen and viral load <50 000 copies/mL, sensitivity of the Ag RDT varied between 13.0% (BD Veritor) and 78.3% (ACON FIA).
CONCLUSIONS: Ag RDTs differ significantly in analytical sensitivity, particularly at viral load <500 000 copies/mL.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:67 |
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| Enthalten in: |
Clinical chemistry - 67(2021), 11 vom: 01. Nov., Seite 1545-1553 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Karon, Brad S [VerfasserIn] |
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| Links: |
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| Themen: |
Antigen |
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| Anmerkungen: |
Date Completed 11.11.2021 Date Revised 11.11.2021 published: Print Citation Status MEDLINE |
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| doi: |
10.1093/clinchem/hvab138 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM327860928 |
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| 100 | 1 | |a Karon, Brad S |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Analytical Sensitivity and Specificity of Four Point of Care Rapid Antigen Diagnostic Tests for SARS-CoV-2 Using Real-Time Quantitative PCR, Quantitative Droplet Digital PCR, and a Mass Spectrometric Antigen Assay as Comparator Methods |
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| 500 | |a Date Revised 11.11.2021 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © American Association for Clinical Chemistry 2021. All rights reserved. For permissions, please email: journals.permissionsoup.com. | ||
| 520 | |a BACKGROUND: We evaluated the analytical sensitivity and specificity of 4 rapid antigen diagnostic tests (Ag RDTs) for severe acute respiratory syndrome coronavirus 2, using reverse transcription quantitative PCR (RT-qPCR) as the reference method and further characterizing samples using droplet digital quantitative PCR (ddPCR) and a mass spectrometric antigen test | ||
| 520 | |a METHODS: Three hundred fifty (150 negative and 200 RT-qPCR positive) residual PBS samples were tested for antigen using the BD Veritor lateral flow (LF), ACON LF, ACON fluorescence immunoassay (FIA), and LumiraDx FIA. ddPCR was performed on RT-qPCR-positive samples to quantitate the viral load in copies/mL applied to each Ag RDT. Mass spectrometric antigen testing was performed on PBS samples to obtain a set of RT-qPCR-positive, antigen-positive samples for further analysis | ||
| 520 | |a RESULTS: All Ag RDTs had nearly 100% specificity compared to RT-qPCR. Overall analytical sensitivity varied from 66.5% to 88.3%. All methods detected antigen in samples with viral load >1 500 000 copies/mL RNA, and detected ≥75% of samples with viral load of 500 000 to 1 500 000 copies/mL. The BD Veritor LF detected only 25% of samples with viral load between 50 000 to 500 000 copies/mL, compared to 75% for the ACON LF device and >80% for LumiraDx and ACON FIA. The ACON FIA detected significantly more samples with viral load <50 000 copies/mL compared to the BD Veritor. Among samples with detectable antigen and viral load <50 000 copies/mL, sensitivity of the Ag RDT varied between 13.0% (BD Veritor) and 78.3% (ACON FIA) | ||
| 520 | |a CONCLUSIONS: Ag RDTs differ significantly in analytical sensitivity, particularly at viral load <500 000 copies/mL | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a antigen | |
| 650 | 4 | |a point of care | |
| 650 | 4 | |a rapid diagnostic test | |
| 650 | 7 | |a Antigens, Viral |2 NLM | |
| 700 | 1 | |a Donato, Leslie J |e verfasserin |4 aut | |
| 700 | 1 | |a Bridgeman, Amber R |e verfasserin |4 aut | |
| 700 | 1 | |a Blommel, Joseph H |e verfasserin |4 aut | |
| 700 | 1 | |a Kipp, Benjamin |e verfasserin |4 aut | |
| 700 | 1 | |a Maus, Anthony |e verfasserin |4 aut | |
| 700 | 1 | |a Renuse, Santosh |e verfasserin |4 aut | |
| 700 | 1 | |a Kemp, Jennifer |e verfasserin |4 aut | |
| 700 | 1 | |a Madugundu, Anil K |e verfasserin |4 aut | |
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| 700 | 1 | |a Dasari, Surendra |e verfasserin |4 aut | |
| 700 | 1 | |a Singh, Ravinder J |e verfasserin |4 aut | |
| 700 | 1 | |a Grebe, Stefan K |e verfasserin |4 aut | |
| 700 | 1 | |a Pandey, Akhilesh |e verfasserin |4 aut | |
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