Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2
The potential of rapid point-of-care (POC) tests has been subject of doubt due to an eventual risk of production errors. The aim was therefore to evaluate the two separate production lots of a commercial POC lateral flow test, intended for the detection of IgM and IgG against the SARS-CoV-2 spike pr...
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| Format: | Article |
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MDPI AG
2021-05-01
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| Series: | Viruses |
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| Online Access: | https://www.mdpi.com/1999-4915/13/6/1043 |
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| author | Tove Hoffman Linda Kolstad Bengt Rönnberg Åke Lundkvist |
| author_facet | Tove Hoffman Linda Kolstad Bengt Rönnberg Åke Lundkvist |
| author_sort | Tove Hoffman |
| collection | DOAJ |
| description | The potential of rapid point-of-care (POC) tests has been subject of doubt due to an eventual risk of production errors. The aim was therefore to evaluate the two separate production lots of a commercial POC lateral flow test, intended for the detection of IgM and IgG against the SARS-CoV-2 spike protein (S1). Control samples consisted of serum from individuals with confirmed SARS-CoV-2 infection and pre-COVID-19 negative sera gathered from a biobank. The presence of anti-S1 IgM/IgG in the sera was verified by an in-house Luminex-based serological assay (COVID-19 SIA). One hundred samples were verified as positive for anti-S1 IgG and 74 for anti-S1 IgM. Two hundred samples were verified as negative for anti-S1 IgM/IgG. For the two lots of the POC-test, the sensitivities were 93.2% and 87.8% for IgM and 93.0% and 100% for IgG. The specificities were 100% for IgM and 99.5% for IgG. The positive predictive value was 100% for IgM and 98.9% and 99.0% for IgG. The negative predictive value was 97.6% and 95.7% for IgM, and 96.6% and 100% for IgG. The evaluated POC-test is suitable to assess anti-SARS-CoV-2 S1 IgM and IgG, as a measure of previous virus exposure on an individual level. The external validation of separate lots of rapid POC-tests is encouraged to ensure high sensitivity before market introduction. |
| first_indexed | 2024-03-10T10:50:32Z |
| format | Article |
| id | doaj.art-262842b7a2ca4e269a8e1eec006438c4 |
| institution | Directory Open Access Journal |
| issn | 1999-4915 |
| language | English |
| last_indexed | 2024-03-10T10:50:32Z |
| publishDate | 2021-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Viruses |
| spelling | doaj.art-262842b7a2ca4e269a8e1eec006438c42023-11-21T22:15:19ZengMDPI AGViruses1999-49152021-05-01136104310.3390/v13061043Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2Tove Hoffman0Linda Kolstad1Bengt Rönnberg2Åke Lundkvist3Department of Medical Biochemistry and Microbiology, Zoonosis Science Center (ZSC), Uppsala University, Husargatan 3, SE-751 23 Uppsala, SwedenDepartment of Medical Biochemistry and Microbiology, Zoonosis Science Center (ZSC), Uppsala University, Husargatan 3, SE-751 23 Uppsala, SwedenDepartment of Medical Biochemistry and Microbiology, Zoonosis Science Center (ZSC), Uppsala University, Husargatan 3, SE-751 23 Uppsala, SwedenDepartment of Medical Biochemistry and Microbiology, Zoonosis Science Center (ZSC), Uppsala University, Husargatan 3, SE-751 23 Uppsala, SwedenThe potential of rapid point-of-care (POC) tests has been subject of doubt due to an eventual risk of production errors. The aim was therefore to evaluate the two separate production lots of a commercial POC lateral flow test, intended for the detection of IgM and IgG against the SARS-CoV-2 spike protein (S1). Control samples consisted of serum from individuals with confirmed SARS-CoV-2 infection and pre-COVID-19 negative sera gathered from a biobank. The presence of anti-S1 IgM/IgG in the sera was verified by an in-house Luminex-based serological assay (COVID-19 SIA). One hundred samples were verified as positive for anti-S1 IgG and 74 for anti-S1 IgM. Two hundred samples were verified as negative for anti-S1 IgM/IgG. For the two lots of the POC-test, the sensitivities were 93.2% and 87.8% for IgM and 93.0% and 100% for IgG. The specificities were 100% for IgM and 99.5% for IgG. The positive predictive value was 100% for IgM and 98.9% and 99.0% for IgG. The negative predictive value was 97.6% and 95.7% for IgM, and 96.6% and 100% for IgG. The evaluated POC-test is suitable to assess anti-SARS-CoV-2 S1 IgM and IgG, as a measure of previous virus exposure on an individual level. The external validation of separate lots of rapid POC-tests is encouraged to ensure high sensitivity before market introduction.https://www.mdpi.com/1999-4915/13/6/1043POC-testlateral flowlotSARS-CoV-2S1IgM/IgG |
| spellingShingle | Tove Hoffman Linda Kolstad Bengt Rönnberg Åke Lundkvist Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2 Viruses POC-test lateral flow lot SARS-CoV-2 S1 IgM/IgG |
| title | Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2 |
| title_full | Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2 |
| title_fullStr | Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2 |
| title_full_unstemmed | Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2 |
| title_short | Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2 |
| title_sort | evaluation of production lots of a rapid point of care lateral flow serological test intended for identification of igm and igg against the n terminal part of the spike protein s1 of sars cov 2 |
| topic | POC-test lateral flow lot SARS-CoV-2 S1 IgM/IgG |
| url | https://www.mdpi.com/1999-4915/13/6/1043 |
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