IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection

Bohn, Mary Kathryn; Mancini, Nicasio; Loh, Tze Ping; Wang, Cheng Bin; Grimmler, Matthias; Gramegna, M.; Yuen, Kwok Yung; Mueller, Robert; Koch, David D.; Sethi, Sunil; Rawlinson, William D.; Clementi, Massimo; Erasmus, Rajiv T; Leportier, Marc; Kwon, Gye Cheol; Menezes, María Elizabeth; Patru, Maria Magdalena; Singh, Krishna Nand; Ferrari, Maurizio; Najjar, Osama; Horvath, Andrea R.; Adeli, Khosrow; Lippi, Giuseppe

doi:10.1515/cclm-2020-1412

Cited by 51 publications

(45 citation statements)

References 36 publications

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“…The FDA has approved methods for SARS-CoV-2 testing using saliva in several laboratories 11,12 . Nevertheless, saliva has been included in IFCC COVID-19 Guidelines on Molecular, Serological, and Biochemical/Haematological Testing as a promising sample type 13 .…”

Section: Discussionmentioning

confidence: 99%

Saliva as a testing sample for SARS-CoV-2 detection by RT-PCR in low prevalence community settings

Gavars¹,

Gavars²,

Perminov³

et al. 2021

Preprint

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There is an urgency for the rapid and simple SARS-CoV-2 detection method. Our study aimed to demonstrate that saliva can be used as a specimen for SARS-CoV-2 detection notably for the screening of extensive population groups via pooling. We collected paired nasopharyngeal/oropharyngeal swabs (NPS) and saliva and performed 36 serial measurements of 8 SARS-CoV-2 positive saliva samples to confirm the stability of the specimen. We also completed 37 pools by adding one positive saliva specimen per pool. A field study including 3,660 participants was performed between September 29 and October 1, 2020. Saliva specimens were stable for testing for up to 24 hours. Overall, 1.2% of the saliva samples tested positive for SARS-CoV-2. The results of saliva samples were consistent with those obtained from NPS with 90% sensitivity (95% CI 68.3%-98.7%) and 100% specificity during the first two weeks after the onset of symptoms. All pools showed 100% positivity in different pooling proportions. Our findings demonstrate that saliva is an appropriate specimen for pooling and SARS-CoV-2 screening with accurate diagnostic performance. Patient-performed specimen collection allows testing an extensive number of people rapidly, obtaining results of the spread of SARS-CoV-2 and allowing authorities to take timely measures.

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Section: Discussionmentioning

confidence: 99%

Saliva as a testing sample for SARS-CoV-2 detection by RT-PCR in low prevalence community settings

Gavars¹,

Gavars²,

Perminov³

et al. 2021

Preprint

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“…La combinación de estos requisitos agregan valor al informe, lo que facilita la confirmación de un caso, la necesidad de realizar otra toma de muestra si el resultado es indeterminado y la capacidad de discernir entre falsos negativos cuando se sospeche de una baja carga viral o un tiempo de evolución prolongado de la enfermedad. 12 Asimismo, la «identificación del laboratorio emisor» y de los «exámenes subcontratados» permiten la comunicación efectiva al favorecer la interconsulta cuando existan dudas sobre la interpretación de los resultados u otros aspectos, además de cubrir aspectos regulatorios como el uso de laboratorios aprobados por las autoridades sanitarias.…”

Section: Liberación Del Informe Y Numeración De Página (O P)unclassified

“…Con fines de inclusión se puede colocar una nota con la identidad de género del paciente en caso de que el paciente no se identifique con su sexo biológico12. Ubicación I,II Para laboratorios públicos, especificar unidad o número de clínica en la que se tomó muestra al paciente Cuando el paciente solicita por su cuenta, escribir el domicilio del paciente Rev CONAMED 2021; 26(1): 3-16 www.medigraphic.org.mx Continúa Tabla 1: I Especifica el nombre del analista o responsable de calidad que validó el resultado En su defecto, contiene una leyenda de que el resultado fue validado como garantía de la trazabilidad del I Elemento de acuerdo con recomendación de ISO 15189.…”

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Calidad del informe de resultados de la detección molecular de SARS-CoV-2: necesidad de estandarización

Mucito-Varela¹

2021

Revista CONAMED

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El informe de resultados es un mecanismo de comunicación entre el laboratorio clínico y los médicos, por lo que su contenido debe ajustarse a los criterios de calidad internacionales. En el contexto de la pandemia por COVID-19, el diagnóstico molecular realizado en 163 laboratorios de México ha incrementado la capacidad diagnóstica y monitoreo epidemiológico. A pesar de contar con guías nacionales e internacionales para la interpretación de este examen, no se ha estandarizado el contenido del informe, lo que aumenta el riesgo de errores que afectan la seguridad del paciente. En este estudio se propone una lista de requisitos estandarizados basados en la Norma ISO 1589:2012, con la cual se evaluó el contenido de 13 informes de laboratorio. Se detectaron requisitos que deben ser mejorados y otros implementados, con el objetivo de garantizar el uso apropiado de la prueba de detección molecular del virus SARS-CoV-2, así como la correcta interpretación y el aseguramiento de la calidad postexamen de los laboratorios clínicos. Es necesario realizar un consenso más detallado en el que participen sociedades de profesionales del laboratorio clínico y médicos para generar un informe que agregue valor a la atención de los pacientes.

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“…Guidelines on Molecular, Serological, and Biochemical/Haematological Testing as a promising sample type (14).…”

Section: Saliva Has Been Identified As a Reliable Testing Specimen Fomentioning

confidence: 99%

Saliva as a testing sample for SARS-CoV-2 detection by RT-PCR in low prevalence community settings

Gavars¹,

Gavars²,

Perminov

et al. 2020

Preprint

View full text Add to dashboard Cite

The aim of our study was to demonstrate that saliva can be used as an effective material for SARS-CoV-2 testing and screening of large population groups to identify Covid-19 clusters. The most important aspect of saliva sampling approach is the convenience of obtaining material by self- sampling that is even possible at home. In our experiments, saliva was sufficiently stable for testing for at least 24 hours after collection. The results obtained from the saliva of a SARS-CoV-2 positive patient were consistent with those obtained from nasopharyngeal and oropharyngeal swabs from the same patient with the sensitivity 90% and specificity 100% during the first two weeks after the onset of symptoms. To demonstrate the usefulness of testing saliva material for mass screening, crowd sampling with pooling was performed on 3660 people in 3-day time (44 samples were tested positive). We conclude that saliva testing is an appropriate tool for screening campaigns and cluster detection, that is able to detect more infected people in a shorter period of time with little human resources and thus help to stop the epidemic spread more quickly.

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IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection

Cited by 51 publications

References 36 publications

Saliva as a testing sample for SARS-CoV-2 detection by RT-PCR in low prevalence community settings

Saliva as a testing sample for SARS-CoV-2 detection by RT-PCR in low prevalence community settings

Calidad del informe de resultados de la detección molecular de SARS-CoV-2: necesidad de estandarización

Saliva as a testing sample for SARS-CoV-2 detection by RT-PCR in low prevalence community settings

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