Analytical assessment of clinical sensitivity and specificities of pharmaceutical rapid SARS-CoV-2 detection nasopharyngeal swab testing kits in Pakistan
Abstract Despite of the global unity against COVID-19 pandemic, the threat of SARS-CoV-2 variants on the lives of human being is still not over. SARS-CoV-2 pandemic has urged the need of rapid viral detection at earliest. To cope with gradually expanding scenario of SARS-CoV-2, accurate diagnosis is...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Instituto Internacional de Ecologia
2024-03-01
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| Series: | Brazilian Journal of Biology |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1519-69842024000101101&lng=en&tlng=en |
| _version_ | 1797277080101060608 |
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| author | U. Saeed R. Uppal A. A. Khan M. R. Uppal Z. Z. Piracha S. R. Uppal |
| author_facet | U. Saeed R. Uppal A. A. Khan M. R. Uppal Z. Z. Piracha S. R. Uppal |
| author_sort | U. Saeed |
| collection | DOAJ |
| description | Abstract Despite of the global unity against COVID-19 pandemic, the threat of SARS-CoV-2 variants on the lives of human being is still not over. SARS-CoV-2 pandemic has urged the need of rapid viral detection at earliest. To cope with gradually expanding scenario of SARS-CoV-2, accurate diagnosis is extremely crucial factor which should be noticed by international health organizations. Limited research followed by sporadic marketing of SARS-CoV-2 rapid pharmaceutical detection kits raises critical questions against quality assurance and quality control measures. Herein we aimed to interrogate effectivity and specificity analysis of SARS-CoV-2 pharmaceutical rapid detection kits (nasopharyngeal swab based) using conventional gold standard triple target real-time polymerase chain reaction (USFDA approved). A cross-sectional study was conducted over 1500 suspected SARS-CoV-2 patients. 100 real time-PCR confirmed patients were evaluated for pharmaceutical RDT kits based upon nasopharyngeal swab based kits. The SARS-CoV-2 nasopharyngeal swab based rapid diagnostic kit (NSP RDTs) analysis showed 78% reactivity. Among real time PCR confirmed negative subjects, 49.3% represented false positivity. The positive predictive analysis revealed 67.82%, while negative predictive values were 64.40%. The NSP RDTs showed limited sensitivities and specificities as compared to gold standard real time PCR. Valid and authentic detection of SARS-CoV-2 is deemed necessary for accurate COVID-19 surveillance across the globe. Current study highlights the potential consequences of inadequate detection of SARS-CoV-2 and emerging novel mutants, compromising vaccine preventable diseases. Current study emphasizes need to wake higher authorities including strategic organizations for designing adequate measures to prevent future SARS-CoV-2 epidemics. |
| first_indexed | 2024-03-07T15:42:31Z |
| format | Article |
| id | doaj.art-5ed8132128f743a9bbb5b1475a85cf23 |
| institution | Directory Open Access Journal |
| issn | 1678-4375 |
| language | English |
| last_indexed | 2024-03-07T15:42:31Z |
| publishDate | 2024-03-01 |
| publisher | Instituto Internacional de Ecologia |
| record_format | Article |
| series | Brazilian Journal of Biology |
| spelling | doaj.art-5ed8132128f743a9bbb5b1475a85cf232024-03-05T07:40:21ZengInstituto Internacional de EcologiaBrazilian Journal of Biology1678-43752024-03-018410.1590/1519-6984.265550Analytical assessment of clinical sensitivity and specificities of pharmaceutical rapid SARS-CoV-2 detection nasopharyngeal swab testing kits in PakistanU. Saeedhttps://orcid.org/0000-0002-9740-0371R. Uppalhttps://orcid.org/0000-0003-1599-651XA. A. Khanhttps://orcid.org/0000-0001-7126-8010M. R. Uppalhttps://orcid.org/0000-0001-6147-788XZ. Z. Pirachahttps://orcid.org/0000-0001-8973-9773S. R. Uppalhttps://orcid.org/0000-0002-4116-1025Abstract Despite of the global unity against COVID-19 pandemic, the threat of SARS-CoV-2 variants on the lives of human being is still not over. SARS-CoV-2 pandemic has urged the need of rapid viral detection at earliest. To cope with gradually expanding scenario of SARS-CoV-2, accurate diagnosis is extremely crucial factor which should be noticed by international health organizations. Limited research followed by sporadic marketing of SARS-CoV-2 rapid pharmaceutical detection kits raises critical questions against quality assurance and quality control measures. Herein we aimed to interrogate effectivity and specificity analysis of SARS-CoV-2 pharmaceutical rapid detection kits (nasopharyngeal swab based) using conventional gold standard triple target real-time polymerase chain reaction (USFDA approved). A cross-sectional study was conducted over 1500 suspected SARS-CoV-2 patients. 100 real time-PCR confirmed patients were evaluated for pharmaceutical RDT kits based upon nasopharyngeal swab based kits. The SARS-CoV-2 nasopharyngeal swab based rapid diagnostic kit (NSP RDTs) analysis showed 78% reactivity. Among real time PCR confirmed negative subjects, 49.3% represented false positivity. The positive predictive analysis revealed 67.82%, while negative predictive values were 64.40%. The NSP RDTs showed limited sensitivities and specificities as compared to gold standard real time PCR. Valid and authentic detection of SARS-CoV-2 is deemed necessary for accurate COVID-19 surveillance across the globe. Current study highlights the potential consequences of inadequate detection of SARS-CoV-2 and emerging novel mutants, compromising vaccine preventable diseases. Current study emphasizes need to wake higher authorities including strategic organizations for designing adequate measures to prevent future SARS-CoV-2 epidemics.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1519-69842024000101101&lng=en&tlng=enSARS-CoV-2COVID-19PakistanNasopharyngeal Swabrapid testing |
| spellingShingle | U. Saeed R. Uppal A. A. Khan M. R. Uppal Z. Z. Piracha S. R. Uppal Analytical assessment of clinical sensitivity and specificities of pharmaceutical rapid SARS-CoV-2 detection nasopharyngeal swab testing kits in Pakistan Brazilian Journal of Biology SARS-CoV-2 COVID-19 Pakistan Nasopharyngeal Swab rapid testing |
| title | Analytical assessment of clinical sensitivity and specificities of pharmaceutical rapid SARS-CoV-2 detection nasopharyngeal swab testing kits in Pakistan |
| title_full | Analytical assessment of clinical sensitivity and specificities of pharmaceutical rapid SARS-CoV-2 detection nasopharyngeal swab testing kits in Pakistan |
| title_fullStr | Analytical assessment of clinical sensitivity and specificities of pharmaceutical rapid SARS-CoV-2 detection nasopharyngeal swab testing kits in Pakistan |
| title_full_unstemmed | Analytical assessment of clinical sensitivity and specificities of pharmaceutical rapid SARS-CoV-2 detection nasopharyngeal swab testing kits in Pakistan |
| title_short | Analytical assessment of clinical sensitivity and specificities of pharmaceutical rapid SARS-CoV-2 detection nasopharyngeal swab testing kits in Pakistan |
| title_sort | analytical assessment of clinical sensitivity and specificities of pharmaceutical rapid sars cov 2 detection nasopharyngeal swab testing kits in pakistan |
| topic | SARS-CoV-2 COVID-19 Pakistan Nasopharyngeal Swab rapid testing |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1519-69842024000101101&lng=en&tlng=en |
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