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Deprecated: Implicit conversion from float 215.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 J+Clin+Virol 2021 ; 138 (ä): 104817 Nephropedia Template TP
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Performance of the RT-LAMP-based eazyplex(R) SARS-CoV-2 as a novel rapid diagnostic test #MMPMID33836452
Egerer R; Edel B; Loffler B; Henke A; Rodel J
J Clin Virol 2021[May]; 138 (ä): 104817 PMID33836452show ga
BACKGROUND: Diagnostic assays for severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) that are easy to perform and produce fast results are essential for timely decision making regarding the isolation of contagious individuals. OBJECTIVE: We evaluated the CE-approved eazyplex(R) SARS-CoV-2, a ready-to-use real time RT-LAMP assay for identification of the SARS-CoV-2?N and ORF8 genes from swabs in less than 30?min without RNA extraction. STUDY DESIGN: Oropharyngeal and nasal swabs from 100 positive and 50 negative patients were inoculated into 0.9 % saline and tested by NeuMoDx RT-PCR. An aliquot was diluted fivefold in Copan sputum liquefying (SL) solution and directly analyzed by eazyplex(R) SARS-CoV-2. In addition, 130 patient swabs were prospectively tested with both methods in parallel. Analytical sensitivity of the assay was determined using virus stock dilutions. RESULTS: Positive percent agreement (PPA) between the eazyplex(R) SARS-CoV-2 and RT-PCR was 74 % for samples with Ct values < 35. When using a Ct cut-off = 28 the PPA increased to 97.4 %. In the prospective part of the study overall PPA of the eazyplex(R) kit was 66.7 % but increased to 100 % when only Ct values = 28 were considered. There were no false positive results. The median time to positivity was 12.5?min for the N gene and 16.75?min for ORF8. Analytical sensitivity was 3.75 TCID(50)/mL. 10(5) virus copies/mL were reproducibly detected. CONCLUSION: The eazyplex(R) SARS-CoV-2 is a rapid assay that accurately identifies samples with high viral loads. It may be useful for near-patient testing outside of a molecular diagnostic laboratory.