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A SARS-CoV-2 nucleocapsid ELISA represents a low-cost alternative to lateral flow testing for community screening in LMI countries

A SARS-CoV-2 nucleocapsid ELISA represents a low-cost alternative to lateral flow testing for community screening in LMI countries
A SARS-CoV-2 nucleocapsid ELISA represents a low-cost alternative to lateral flow testing for community screening in LMI countries
Background: Controlling the spread of SARS-CoV-2 is problematic because of transmission driven by asymptomatic and pre-symptomatic individuals. Community screening can help identify these individuals but is often too expensive for countries with limited health care resources. Low-cost ELISA assays may address this problem, but their use has not yet been widely reported. Methods: We developed a SARS-CoV-2 nucleocapsid ELISA and assessed its diagnostic performance on nose and throat swab samples from UK hospitalised patients and sputum samples from patients in Ghana. Results: The ELISA had a limit of detection of 8.4 pg/ml antigen and 16 pfu/ml virus. When tested on UK samples (128 positive and 10 negative patients), sensitivity was 58.6% (49.6-67.2) rising to 78.3% (66.7-87.3) if real-time PCR Ct values >30 were excluded, while specificity was 100% (69.2-100). In a second trial using the Ghanaian samples (121 positive, 96 negative), sensitivity was 52% (42.8-61.2) rising to 72.6% (61.8-81.2) when a >30 Ct cut-off was applied, while specificity was 100% (96.2-100). Conclusions: Our data show that nucleocapsid ELISAs can test a variety of patient sample types while achieving levels of sensitivity and specificity required for effective community screening. Further investigations into the opportunities that this provides are warranted.
Diagnosis, ELISA, Nucleocapsid, SARS-cov-2, Test
0163-4453
Humbert, Maria
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Opurum, Precious
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Brendish, Nathan
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Poole, Stephen
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He, Peijun
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Katis, Ioannis
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Quaye, Jerry
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Bediako, Yaw
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Duriez, Patrick
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Eason, R.W.
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Sones, Collin
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Quaye, Osbourne
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Awandare, Gordon
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Christodoulides, Myron
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Clark, Tristan
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Quashie, Peter
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Mccormick, Christopher
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Humbert, Maria
82134d25-24b8-4fdd-bd1c-461683b5322e
Opurum, Precious
d8b75d89-9bf3-4c07-b0d4-38aad5a68854
Brendish, Nathan
a8a4189e-01eb-4ab3-933e-a24cd188a4d7
Poole, Stephen
440d7904-ab72-469c-892b-c910cd1cb19b
He, Peijun
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Katis, Ioannis
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Quaye, Jerry
f232565b-c60a-47fd-a833-d9efadc93ef9
Bediako, Yaw
d5fc5c54-90a1-4d7c-ba90-6f97b7c4654d
Duriez, Patrick
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Eason, R.W.
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Sones, Collin
9de9d8ee-d394-46a5-80b7-e341c0eed0a8
Quaye, Osbourne
ea12ea99-a5e5-461f-aa85-657a2b071164
Awandare, Gordon
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Christodoulides, Myron
eba99148-620c-452a-a334-c1a52ba94078
Clark, Tristan
712ec18e-613c-45df-a013-c8a22834e14f
Quashie, Peter
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Mccormick, Christopher
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Humbert, Maria, Opurum, Precious, Brendish, Nathan, Poole, Stephen, He, Peijun, Katis, Ioannis, Quaye, Jerry, Bediako, Yaw, Duriez, Patrick, Eason, R.W., Sones, Collin, Quaye, Osbourne, Awandare, Gordon, Christodoulides, Myron, Clark, Tristan, Quashie, Peter and Mccormick, Christopher (2021) A SARS-CoV-2 nucleocapsid ELISA represents a low-cost alternative to lateral flow testing for community screening in LMI countries. Journal of Infection, [YJINF_YJINF-D-21-01816]. (doi:10.1016/j.jinf.2021.08.049).

Record type: Article

Abstract

Background: Controlling the spread of SARS-CoV-2 is problematic because of transmission driven by asymptomatic and pre-symptomatic individuals. Community screening can help identify these individuals but is often too expensive for countries with limited health care resources. Low-cost ELISA assays may address this problem, but their use has not yet been widely reported. Methods: We developed a SARS-CoV-2 nucleocapsid ELISA and assessed its diagnostic performance on nose and throat swab samples from UK hospitalised patients and sputum samples from patients in Ghana. Results: The ELISA had a limit of detection of 8.4 pg/ml antigen and 16 pfu/ml virus. When tested on UK samples (128 positive and 10 negative patients), sensitivity was 58.6% (49.6-67.2) rising to 78.3% (66.7-87.3) if real-time PCR Ct values >30 were excluded, while specificity was 100% (69.2-100). In a second trial using the Ghanaian samples (121 positive, 96 negative), sensitivity was 52% (42.8-61.2) rising to 72.6% (61.8-81.2) when a >30 Ct cut-off was applied, while specificity was 100% (96.2-100). Conclusions: Our data show that nucleocapsid ELISAs can test a variety of patient sample types while achieving levels of sensitivity and specificity required for effective community screening. Further investigations into the opportunities that this provides are warranted.

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Accepted/In Press date: 28 August 2021
e-pub ahead of print date: 1 October 2021
Keywords: Diagnosis, ELISA, Nucleocapsid, SARS-cov-2, Test

Identifiers

Local EPrints ID: 451544
URI: http://eprints.soton.ac.uk/id/eprint/451544
ISSN: 0163-4453
PURE UUID: 300a150c-af8c-4fcd-9b69-3ee53775fd54
ORCID for Maria Humbert: ORCID iD orcid.org/0000-0002-5728-6981
ORCID for Nathan Brendish: ORCID iD orcid.org/0000-0002-9589-4937
ORCID for Ioannis Katis: ORCID iD orcid.org/0000-0002-2016-557X
ORCID for R.W. Eason: ORCID iD orcid.org/0000-0001-9704-2204
ORCID for Myron Christodoulides: ORCID iD orcid.org/0000-0002-9663-4731
ORCID for Tristan Clark: ORCID iD orcid.org/0000-0001-6026-5295
ORCID for Christopher Mccormick: ORCID iD orcid.org/0000-0002-6155-9161

Catalogue record

Date deposited: 06 Oct 2021 19:13
Last modified: 26 Nov 2021 03:21

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Contributors

Author: Maria Humbert ORCID iD
Author: Precious Opurum
Author: Nathan Brendish ORCID iD
Author: Stephen Poole
Author: Peijun He
Author: Ioannis Katis ORCID iD
Author: Jerry Quaye
Author: Yaw Bediako
Author: Patrick Duriez
Author: R.W. Eason ORCID iD
Author: Collin Sones
Author: Osbourne Quaye
Author: Gordon Awandare
Author: Tristan Clark ORCID iD
Author: Peter Quashie

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