Clinical diagnosis of 8274 samples with 2019-novel coronavirus in Wuhan

Background2019-Novel coronavirus (2019-nCoV) outbreaks create challenges for hospital laboratories because thousands of samples must be evaluated each day. Sample types, interpretation methods, and corresponding laboratory standards must be established. The possibility of other infections should be assessed to provide a basis for clinical classification, isolation, and treatment. Accordingly, in the present study, we evaluated the testing methods for 2019-nCoV and co-infections. MethodsWe used a fluorescence-based quantitative PCR kit urgently distributed by the Chinese CDC to detect 8274 close contacts in the Wuhan region against two loci on the 2019-nCoV genome. We also analyzed 613 patients with fever who underwent multiple tests for 13 respiratory pathogens; 316 subjects were also tested for 2019-nCoV. FindingsAmong the 8274 subjects, 2745 (33.2%) had 2019-nCoV infection; 5277 (63.8%) subjects showed negative results in the 2019-nCoV nucleic acid test (non-2019-nCoV); and 252 cases (3.0%) because only one target was positive, the diagnosis was not definitive. Eleven patients who originally had only one positive target were re-examined a few days later; 9 patients (81.8%) were finally defined as 2019-nCoV-positive, and 2 (18.2%) were finally defined as negative. The positive rates of nCoV-NP and nCovORF1ab were 34.7% and 34.7%, respectively. nCoV-NP-positive only and nCovORF1ab-positive cases accounted for 1.5% and 1.5%, respectively. In the 316 patients with multiple respiratory pathogens, 104 were positive for 2019-nCov and 6/104 had co-infection with coronavirus (3/104), influenza A virus (2/104), rhinovirus (2/104), and influenza A H3N2 (1/104); the remaining 212 patients had influenza A virus (11/202), influenza A H3N2 (11/202), rhinovirus (10/202), respiratory syncytial virus (7/202), influenza B virus (6/202), metapneumovirus (4/202), and coronavirus (2/202). InterpretationClinical testing methods for 2019-nCoV require improvement. Importantly, 5.8% of 2019-nCoV infected and 18.4% of non-2019-nCoV-infected patients had other pathogen infections. It is important to treat combined infections and perform rapid screening to avoid cross-contamination of patients. A test that quickly and simultaneously screens as many pathogens as possible is needed. FundingNo founding was received Research in contextO_ST_ABSEvidence before this studyC_ST_ABSWe searched PubMed for articles published up to January 31, 2020 using the keywords "2019 novel coronavirus" or "2019-nCoV". No published study on the characteristics of 2019-nCoV tests or 2019-nCoV co-infections was found. We only noted recent laboratory findings for other tests of patients infected with 2019-nCoV. Added value of this studyPositive detection of nCoV-NP or nCovORF1ab is presented, and individuals with/without 2019-nCoV infections or with inconclusive results were identified. Patients with inconclusive results may be diagnosed with 2019-nCoV infection or found to be negative for the infection after resampling and retesting in the next few days. Approximately 5.8% of the subjects diagnosed with 2019-nCoV had co-infection. Implications of all the available evidenceManagement of the population showing inconclusive results should be given attention; additionally, such results can be minimized by improving the sampling, sample pretreatment, and testing methodologies. When diagnosing 2019-nCoV subjects, the possibility of co-infection should be considered. Finally, better clinical detection methods are needed to simultaneously screen as many pathogens as possible.