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10.1016/S2666-5247(21)00092-6 http://scihub22266oqcxt.onion/10.1016/S2666-5247(21)00092-6 34031649!8133768!34031649     free     free     free Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 267.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 267.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Lancet+Microbe 2021 ; 2 (8): e397-e404 Nephropedia Template TP {{tp|p=34031649|t=2021. A novel strategy for SARS-CoV-2 mass screening with quantitative antigen testing of saliva: a diagnostic accuracy study |pdf=|usr=}}{{34031649}} gab.com Text A novel strategy for SARS-CoV-2 mass screening with quantitative antigen testing of saliva: a diagnostic accuracy study JO: Lancet Microbe http://www.kidney.de/pget.php?&tw=1&pmid=34031649 #FOAvip BACKGROUND: Quantitative RT-PCR (RT-qPCR) of nasopharyngeal swab (NPS) samples for SARS-CoV-2 detection requires medical personnel and is time consuming, and thus is poorly suited to mass screening. In June, 2020, a chemiluminescent enzyme immunoassay (CLEIA; Lumipulse G SARS-CoV-2 Ag kit, Fujirebio, Tokyo, Japan) was developed that can detect SARS-CoV-2 nucleoproteins in NPS or saliva samples within 35 min. In this study, we assessed the utility of CLEIA in mass SARS-CoV-2 screening. METHODS: We did a diagnostic accuracy study to develop a mass-screening strategy for salivary detection of SARS-CoV-2 by CLEIA, enrolling hospitalised patients with clinically confirmed COVID-19, close contacts identified at community health centres, and asymptomatic international arrivals at two airports, all based in Japan. All test participants were enrolled consecutively. We assessed the diagnostic accuracy of CLEIA compared with RT-qPCR, estimated according to concordance (Kendall's coefficient of concordance, W), and sensitivity (probability of CLEIA positivity given RT-qPCR positivity) and specificity (probability of CLEIA negativity given RT-qPCR negativity) for different antigen concentration cutoffs (0.19 pg/mL, 0.67 pg/mL, and 4.00 pg/mL; with samples considered positive if the antigen concentration was equal to or more than the cutoff and negative if it was less than the cutoff). We also assessed a two-step testing strategy post hoc with CLEIA as an initial test, using separate antigen cutoff values for test negativity and positivity from the predefined cutoff values. The proportion of intermediate results requiring secondary RT-qPCR was then quantified assuming prevalence values of RT-qPCR positivity in the overall tested population of 10%, 30%, and 50%. FINDINGS: Self-collected saliva was obtained from 2056 participants between June 12 and Aug 6, 2020. Results of CLEIA and RT-qPCR were concordant in 2020 (98.2%) samples (Kendall's W=0.99). Test sensitivity was 85.4% (76 of 89 positive samples; 90% credible interval [CrI] 78.0-90.3) at the cutoff of 0.19 pg/mL; 76.4% (68 of 89; 68.2-82.8) at the cutoff of 0.67 pg/mL; and 52.8% (47 of 89; 44.1-61.3) at the cutoff of 4.0 pg/mL. Test specificity was 91.3% (1796 of 1967 negative samples; 90% CrI 90.2-92.3) at the cutoff of 0.19 pg/mL, 99.2% (1952 of 1967; 98.8-99.5) at the cutoff of 0.67 pg/mL, and 100.0% (1967 of 1967; 99.8-100.0) at the cutoff of 4.00 pg/mL. Using a two-step testing strategy with a CLEIA negativity cutoff of 0.19 pg/mL (to maximise sensitivity) and a CLEIA positivity cutoff of 4.00 pg/mL (to maximise specificity), the proportions of indeterminate results (ie, samples requiring secondary RT-qPCR) would be approximately 11% assuming a prevalence of RT-qPCR positivity of 10%, 16% assuming a prevalence of RT-qPCR positivity of 30%, and 21% assuming a prevalence of RT-qPCR positivity of 50%. INTERPRETATION: CLEIA testing of self-collected saliva is simple and provides results quickly, and is thus suitable for mass testing. To improve accuracy, we propose a two-step screening strategy with an initial CLEIA test followed by confirmatory RT-qPCR for intermediate concentrations, varying positive and negative thresholds depending on local prevalence. Implementation of this strategy has expedited sample processing at Japanese airports since July, 2020, and might apply to other large-scale mass screening initiatives. FUNDING: Ministry of Health, Labour and Welfare, Japan. Twit Text FOAVip A novel strategy for SARS-CoV-2 mass screening with quantitative antigen testing of saliva: a diagnostic accuracy study ????Lancet Microbe http://www.kidney.de/pget.php?&tw=1&pmid=34031649 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=34031649 #FOAvip English Wikipedia <ref>{{Cite pmid|34031649}}</ref> A novel strategy for SARS-CoV-2 mass screening with quantitative antigen testing of saliva: a diagnostic accuracy study #MMPMID34031649 Yokota I; Shane PY; Okada K; Unoki Y; Yang Y; Iwasaki S; Fujisawa S; Nishida M; Teshima T Lancet Microbe 2021[Aug]; 2 (8): e397-e404 PMID34031649show ga BACKGROUND: Quantitative RT-PCR (RT-qPCR) of nasopharyngeal swab (NPS) samples for SARS-CoV-2 detection requires medical personnel and is time consuming, and thus is poorly suited to mass screening. In June, 2020, a chemiluminescent enzyme immunoassay (CLEIA; Lumipulse G SARS-CoV-2 Ag kit, Fujirebio, Tokyo, Japan) was developed that can detect SARS-CoV-2 nucleoproteins in NPS or saliva samples within 35 min. In this study, we assessed the utility of CLEIA in mass SARS-CoV-2 screening. METHODS: We did a diagnostic accuracy study to develop a mass-screening strategy for salivary detection of SARS-CoV-2 by CLEIA, enrolling hospitalised patients with clinically confirmed COVID-19, close contacts identified at community health centres, and asymptomatic international arrivals at two airports, all based in Japan. All test participants were enrolled consecutively. We assessed the diagnostic accuracy of CLEIA compared with RT-qPCR, estimated according to concordance (Kendall's coefficient of concordance, W), and sensitivity (probability of CLEIA positivity given RT-qPCR positivity) and specificity (probability of CLEIA negativity given RT-qPCR negativity) for different antigen concentration cutoffs (0.19 pg/mL, 0.67 pg/mL, and 4.00 pg/mL; with samples considered positive if the antigen concentration was equal to or more than the cutoff and negative if it was less than the cutoff). We also assessed a two-step testing strategy post hoc with CLEIA as an initial test, using separate antigen cutoff values for test negativity and positivity from the predefined cutoff values. The proportion of intermediate results requiring secondary RT-qPCR was then quantified assuming prevalence values of RT-qPCR positivity in the overall tested population of 10%, 30%, and 50%. FINDINGS: Self-collected saliva was obtained from 2056 participants between June 12 and Aug 6, 2020. Results of CLEIA and RT-qPCR were concordant in 2020 (98.2%) samples (Kendall's W=0.99). Test sensitivity was 85.4% (76 of 89 positive samples; 90% credible interval [CrI] 78.0-90.3) at the cutoff of 0.19 pg/mL; 76.4% (68 of 89; 68.2-82.8) at the cutoff of 0.67 pg/mL; and 52.8% (47 of 89; 44.1-61.3) at the cutoff of 4.0 pg/mL. Test specificity was 91.3% (1796 of 1967 negative samples; 90% CrI 90.2-92.3) at the cutoff of 0.19 pg/mL, 99.2% (1952 of 1967; 98.8-99.5) at the cutoff of 0.67 pg/mL, and 100.0% (1967 of 1967; 99.8-100.0) at the cutoff of 4.00 pg/mL. Using a two-step testing strategy with a CLEIA negativity cutoff of 0.19 pg/mL (to maximise sensitivity) and a CLEIA positivity cutoff of 4.00 pg/mL (to maximise specificity), the proportions of indeterminate results (ie, samples requiring secondary RT-qPCR) would be approximately 11% assuming a prevalence of RT-qPCR positivity of 10%, 16% assuming a prevalence of RT-qPCR positivity of 30%, and 21% assuming a prevalence of RT-qPCR positivity of 50%. INTERPRETATION: CLEIA testing of self-collected saliva is simple and provides results quickly, and is thus suitable for mass testing. To improve accuracy, we propose a two-step screening strategy with an initial CLEIA test followed by confirmatory RT-qPCR for intermediate concentrations, varying positive and negative thresholds depending on local prevalence. Implementation of this strategy has expedited sample processing at Japanese airports since July, 2020, and might apply to other large-scale mass screening initiatives. FUNDING: Ministry of Health, Labour and Welfare, Japan. |*COVID-19/diagnosis[MESH] |*SARS-CoV-2/genetics[MESH] |Humans[MESH] |Mass Screening/methods[MESH] |Saliva[MESH]A novel strategy for SARS-CoV-2 mass screening with quantitative antig(epmc).pdf DeepDyve Pubget Overpricing