Evaluation of SARS-CoV-2 Antigen-Based Rapid Diagnostic Kits in Pakistan: Formulation of COVID-19 National Testing Strategy.

Saeed, Umar; Uppal, Sara Rizwan; Piracha, Zahra Zahid; Rasheed, Azhar; Aftab, Zubair; Zaheer, Hafsah; Uppal, Rizwan

doi:10.21203/rs.3.rs-113852/v1

Cited by 8 publications

(16 citation statements)

References 14 publications

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“…During the second wave of COVID-19 we aimed to re-investigate new COVID-19 testing RDT diagnostic kits. In continuation of our previous study(6), current study indicated that in comparison to gold standard, RT-PCR based COVID-19 detection kit, the nasal RDT showed improved 78 % sensitivity, while 21% showed false negative results. The NSP based RDTs kit showed zero cross reactivity against Human metapneumovirus, Mumps virus, Rotavirus, Adenovirus, Epstein-Barr virus, human Coronavirus OC43, Mycoplasma pneumonia Varicella Zosyer virus, Respiratory Syncytial virus, Cytomegalovirus, Measels virus, In uenza viruses and Norovirus.…”

supporting

confidence: 76%

“…Recently, from Pakistan nasal and saliva based RDTs revealed sensitivities of 52% and 21% respectively (6). The current study revealed that RT-PCR analysis from study enrolled subjects (during second COVID-19 wave) revealed that prevalence rate of COVID-19 during the period of November in Islamabad/Rawalpindi region of Pakistan was 6.67%, which is 22 times higher than COVID-19 prevalence during October 2020 (6).…”

Section: Discussionmentioning

confidence: 59%

“…Previously we evaluated SARS-CoV-2 rapid diagnostic test in Pakistan and demonstrated that RDT based diagnostic kits need to be investigated before commercialization of the products (6). Despite of limited sensitivities and speci cities several SARS-CoV-2 RDT based kits are being utilized by many diagnostic centers across Pakistan which needs to be re-monitored on priority basis to estimate accurate COVID-19 trends among several populations in Pakistan.…”

Section: Discussionmentioning

confidence: 99%

“…Rapid diagnostic tests (RDTs) are easy to use, cheaper and safe to use, but there are several potential concerns regarding validation and accurate performance of these diagnostic assays (5). Previously, in comparison to gold-standard PCR positive patients, we showed the sensitivities of nasopharyngeal swab (52%) and saliva based (21%) SARS-CoV-2 antigen based rapid diagnostic kits in Pakistan (6). To validate further the accurate diagnosis of nasopharyngeal swab rapid diagnostic kits we further evaluated COVID-19 antigen based kits.…”

Section: Introductionmentioning

confidence: 99%

“…Routes of transmission such as aerosol and digestive tract have yet to be investigated further(3,4).Rapid diagnostic tests (RDTs) are easy to use, cheaper and safe to use, but there are several potential concerns regarding validation and accurate performance of these diagnostic assays(5). Previously, in comparison to gold-standard PCR positive patients, we showed the sensitivities of nasopharyngeal swab (52%) and saliva based (21%) SARS-CoV-2 antigen based rapid diagnostic kits in Pakistan(6). To validate further the accurate diagnosis of nasopharyngeal swab rapid diagnostic kits we further evaluated COVID-19 antigen based kits.Materials And MethodsA cross-sectional, among 1500 COVID-19 suspected subjects, was conducted during the period of November, 2020 from capital twin cities (Islamabad and Rawalpindi) of Pakistan.…”

mentioning

confidence: 99%

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Effectivity Analysis of SARS-CoV-2 Nasopharyngeal Swab Rapid Testing Kits in Pakistan: A Scenario of Inadequate COVID-19 Diagnosis

Saeed¹,

Uppal²,

Piracha³

et al. 2021

Preprint

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COVID-19 pandemic has urged the need of rapid detection of SARS-CoV-2 in limited time frame. To cope with current, COVID-19 expanding scenario, accurate diagnosis of SARS-CoV-2 should be ensured by both national and international health organizations. Sporadic marketing of SARS-CoV-2 rapid detection kits raises questions regarding quality control and assurance. To aim of this study was to examine the effectiveness of SARS-CoV-2 nasopharyngeal swab based rapid detection kits, in comparison to gold standard USFDA approved triple target real-time polymerase chain reaction. A cross-sectional study of 1500 suspected COVID-19 patients was conducted. 100 RT-PCR confirmed patients nasopharyngeal swabs were evaluated for RDT. The COVID-19/SARS-CoV-2 NSP based RDT analysis showed 78% reactivity. Among RT-PCR confirmed negative subjects, 49.3% showed false positivity. The positive predictive analysis revealed 67.82% values, while the negative predictive vales of were 64.40%. The NSP RDTs showed limited sensitivities and specificities compared to gold standard RT-PCR. Accurate surveillance of COVID-19 is dependent upon authentic and validated SARS-CoV-2 detection nation-wide, which needs to be monitored by higher authorities. This study is critical for designing adequate measures by several COVID-19 strategic organizations to prevent future viral epidemics.

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supporting

confidence: 76%

Section: Discussionmentioning

confidence: 59%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Effectivity Analysis of SARS-CoV-2 Nasopharyngeal Swab Rapid Testing Kits in Pakistan: A Scenario of Inadequate COVID-19 Diagnosis

Saeed¹,

Uppal²,

Piracha³

et al. 2021

Preprint

Self Cite

View full text Add to dashboard Cite

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Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh

Rahman¹,

Hoque²,

Karim³

et al. 2021

Heliyon

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An assessment of a rapid SARS-CoV-2 antigen test in Bangladesh

Kawser

Hossain

Suliman

et al. 2021

Preprint

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Early detection of SARS-CoV-2 infection is crucial to prevent the spread of the virus. In this study, we evaluated the performance of a commercial rapid antigen detection test, BD Veritor, and compared this (and another rapid test, Standard Q) against a gold-standard of nasopharyngeal (NP) swab tested by reverse transcription-polymerase chain reaction (RT-PCR) in prospectively recruited adults in Dhaka, Bangladesh. We compared the sensitivity and specificity of the two rapid antigen tests against RT-PCR results in 130 symptomatic and 130 asymptomatic adults. In addition, we evaluated the suitability and ease-of-use of the BD Veritor test in a subsample of study participants (n=42) and implementers (n=5). The sensitivity of the BD Veritor rapid antigen 66 test was 70% in symptomatic (95% confidence interval [CI]: 51-85%) and 87% (95% CI: 69-96%) in asymptomatic individuals with positive SARSCoV-2 RT-PCR, for overall sensitivity of 78% (95% CI: 66-88%). The sensitivity of the Standard Q rapid antigen test was 63% (95% CI: 44-69 80%) in symptomatic and 73% (95% CI: 54-87%) in asymptomatic individuals. One false positive in BD Veritor test (specificity 99.5) and no false positive in Standard Q tests were observed (specificity 100%). The BD Veritor rapid antigen test was 78% sensitive when compared with RT-PCR irrespective of the cycle threshold (Ct) levels in this evaluation in Bangladesh. The implementation evaluation data showed good acceptability in the field settings. This warrants large field evaluation as well as use of the rapid antigen test for quick assessment of SARS-CoV-2 for containment of epidemics in the country.

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Evaluation of SARS-CoV-2 Antigen-Based Rapid Diagnostic Kits in Pakistan: Formulation of COVID-19 National Testing Strategy.

Cited by 8 publications

References 14 publications

Effectivity Analysis of SARS-CoV-2 Nasopharyngeal Swab Rapid Testing Kits in Pakistan: A Scenario of Inadequate COVID-19 Diagnosis

Effectivity Analysis of SARS-CoV-2 Nasopharyngeal Swab Rapid Testing Kits in Pakistan: A Scenario of Inadequate COVID-19 Diagnosis

Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh

An assessment of a rapid SARS-CoV-2 antigen test in Bangladesh

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