Diagnostic accuracy of the Panbio COVID-19 antigen rapid test device for SARS-CoV-2 detection in Kenya, 2021 : A field evaluation
Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication..
BACKGROUND: Accurate and timely diagnosis is essential in limiting the spread of SARS-CoV-2 infection. The reference standard, rRT-PCR, requires specialized laboratories, costly reagents, and a long turnaround time. Antigen RDTs provide a feasible alternative to rRT-PCR since they are quick, relatively inexpensive, and do not require a laboratory. The WHO requires that Ag RDTs have a sensitivity ≥80% and specificity ≥97%.
METHODS: This evaluation was conducted at 11 health facilities in Kenya between March and July 2021. We enrolled persons of any age with respiratory symptoms and asymptomatic contacts of confirmed COVID-19 cases. We collected demographic and clinical information and two nasopharyngeal specimens from each participant for Ag RDT testing and rRT-PCR. We calculated the diagnostic performance of the Panbio™ Ag RDT against the US Centers for Disease Control and Prevention's (CDC) rRT-PCR test.
RESULTS: We evaluated the Ag RDT in 2,245 individuals where 551 (24.5%, 95% CI: 22.8-26.3%) tested positive by rRT-PCR. Overall sensitivity of the Ag RDT was 46.6% (95% CI: 42.4-50.9%), specificity 98.5% (95% CI: 97.8-99.0%), PPV 90.8% (95% CI: 86.8-93.9%) and NPV 85.0% (95% CI: 83.4-86.6%). Among symptomatic individuals, sensitivity was 60.6% (95% CI: 54.3-66.7%) and specificity was 98.1% (95% CI: 96.7-99.0%). Among asymptomatic individuals, sensitivity was 34.7% (95% CI 29.3-40.4%) and specificity was 98.7% (95% CI: 97.8-99.3%). In persons with onset of symptoms <5 days (594/876, 67.8%), sensitivity was 67.1% (95% CI: 59.2-74.3%), and 53.3% (95% CI: 40.0-66.3%) among those with onset of symptoms >7 days (157/876, 17.9%). The highest sensitivity was 87.0% (95% CI: 80.9-91.8%) in symptomatic individuals with cycle threshold (Ct) values ≤30.
CONCLUSION: The overall sensitivity and NPV of the Panbio™ Ag RDT were much lower than expected. The specificity of the Ag RDT was high and satisfactory; therefore, a positive result may not require confirmation by rRT-PCR. The kit may be useful as a rapid screening tool only for symptomatic patients in high-risk settings with limited access to rRT-PCR. A negative result should be interpreted based on clinical and epidemiological information and may require retesting by rRT-PCR.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
|---|---|
| Enthalten in: |
PloS one - 18(2023), 1 vom: 01., Seite e0277657 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Irungu, Jack Karuga [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antigens, Viral |
|---|
| Anmerkungen: |
Date Completed 01.02.2023 Date Revised 15.03.2023 published: Electronic-eCollection Dryad: 10.5061/dryad.5hqbzkh8v Citation Status MEDLINE |
|---|
| doi: |
10.1371/journal.pone.0277657 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM352074159 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM352074159 | ||
| 003 | DE-627 | ||
| 005 | 20231226052903.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1371/journal.pone.0277657 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1173.xml |
| 035 | |a (DE-627)NLM352074159 | ||
| 035 | |a (NLM)36696882 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Irungu, Jack Karuga |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Diagnostic accuracy of the Panbio COVID-19 antigen rapid test device for SARS-CoV-2 detection in Kenya, 2021 |b A field evaluation |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 01.02.2023 | ||
| 500 | |a Date Revised 15.03.2023 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Dryad: 10.5061/dryad.5hqbzkh8v | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication. | ||
| 520 | |a BACKGROUND: Accurate and timely diagnosis is essential in limiting the spread of SARS-CoV-2 infection. The reference standard, rRT-PCR, requires specialized laboratories, costly reagents, and a long turnaround time. Antigen RDTs provide a feasible alternative to rRT-PCR since they are quick, relatively inexpensive, and do not require a laboratory. The WHO requires that Ag RDTs have a sensitivity ≥80% and specificity ≥97% | ||
| 520 | |a METHODS: This evaluation was conducted at 11 health facilities in Kenya between March and July 2021. We enrolled persons of any age with respiratory symptoms and asymptomatic contacts of confirmed COVID-19 cases. We collected demographic and clinical information and two nasopharyngeal specimens from each participant for Ag RDT testing and rRT-PCR. We calculated the diagnostic performance of the Panbio™ Ag RDT against the US Centers for Disease Control and Prevention's (CDC) rRT-PCR test | ||
| 520 | |a RESULTS: We evaluated the Ag RDT in 2,245 individuals where 551 (24.5%, 95% CI: 22.8-26.3%) tested positive by rRT-PCR. Overall sensitivity of the Ag RDT was 46.6% (95% CI: 42.4-50.9%), specificity 98.5% (95% CI: 97.8-99.0%), PPV 90.8% (95% CI: 86.8-93.9%) and NPV 85.0% (95% CI: 83.4-86.6%). Among symptomatic individuals, sensitivity was 60.6% (95% CI: 54.3-66.7%) and specificity was 98.1% (95% CI: 96.7-99.0%). Among asymptomatic individuals, sensitivity was 34.7% (95% CI 29.3-40.4%) and specificity was 98.7% (95% CI: 97.8-99.3%). In persons with onset of symptoms <5 days (594/876, 67.8%), sensitivity was 67.1% (95% CI: 59.2-74.3%), and 53.3% (95% CI: 40.0-66.3%) among those with onset of symptoms >7 days (157/876, 17.9%). The highest sensitivity was 87.0% (95% CI: 80.9-91.8%) in symptomatic individuals with cycle threshold (Ct) values ≤30 | ||
| 520 | |a CONCLUSION: The overall sensitivity and NPV of the Panbio™ Ag RDT were much lower than expected. The specificity of the Ag RDT was high and satisfactory; therefore, a positive result may not require confirmation by rRT-PCR. The kit may be useful as a rapid screening tool only for symptomatic patients in high-risk settings with limited access to rRT-PCR. A negative result should be interpreted based on clinical and epidemiological information and may require retesting by rRT-PCR | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Research Support, U.S. Gov't, Non-P.H.S. | |
| 650 | 7 | |a Antigens, Viral |2 NLM | |
| 700 | 1 | |a Munyua, Peninah |e verfasserin |4 aut | |
| 700 | 1 | |a Ochieng, Caroline |e verfasserin |4 aut | |
| 700 | 1 | |a Juma, Bonventure |e verfasserin |4 aut | |
| 700 | 1 | |a Amoth, Patrick |e verfasserin |4 aut | |
| 700 | 1 | |a Kuria, Francis |e verfasserin |4 aut | |
| 700 | 1 | |a Kiiru, John |e verfasserin |4 aut | |
| 700 | 1 | |a Makayotto, Lyndah |e verfasserin |4 aut | |
| 700 | 1 | |a Abade, Ahmed |e verfasserin |4 aut | |
| 700 | 1 | |a Bulterys, Marc |e verfasserin |4 aut | |
| 700 | 1 | |a Hunsperger, Elizabeth |e verfasserin |4 aut | |
| 700 | 1 | |a Emukule, Gideon O |e verfasserin |4 aut | |
| 700 | 1 | |a Onyango, Clayton |e verfasserin |4 aut | |
| 700 | 1 | |a Samandari, Taraz |e verfasserin |4 aut | |
| 700 | 1 | |a Barr, Beth A Tippett |e verfasserin |4 aut | |
| 700 | 1 | |a Akelo, Victor |e verfasserin |4 aut | |
| 700 | 1 | |a Weyenga, Herman |e verfasserin |4 aut | |
| 700 | 1 | |a Munywoki, Patrick K |e verfasserin |4 aut | |
| 700 | 1 | |a Bigogo, Godfrey |e verfasserin |4 aut | |
| 700 | 1 | |a Otieno, Nancy A |e verfasserin |4 aut | |
| 700 | 1 | |a Kisivuli, Jackton Azenga |e verfasserin |4 aut | |
| 700 | 1 | |a Ochieng, Edwin |e verfasserin |4 aut | |
| 700 | 1 | |a Nyaga, Rufus |e verfasserin |4 aut | |
| 700 | 1 | |a Hull, Noah |e verfasserin |4 aut | |
| 700 | 1 | |a Herman-Roloff, Amy |e verfasserin |4 aut | |
| 700 | 1 | |a Aman, Rashid |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t PloS one |d 2006 |g 18(2023), 1 vom: 01., Seite e0277657 |w (DE-627)NLM167327399 |x 1932-6203 |7 nnns |
| 773 | 1 | 8 | |g volume:18 |g year:2023 |g number:1 |g day:01 |g pages:e0277657 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1371/journal.pone.0277657 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 18 |j 2023 |e 1 |b 01 |h e0277657 | ||