Abstract：
:As new tests and technologies advance our understanding and diagnostic capabilities of the severe acute respiratory syndrome coronavirus 2 and the coronavirus disease 2019, they must be appropriately validated to make sure test performance is following manufacturer claims. In this study, we evaluated the Vazyme 2019-nCoV IgG/IgM Detection Kit, which is a lateral flow assay (LFA), by the plaque reduction neutralization test (PRNT) using 100 patient plasma/serum samples. As compared to the PRNT results, the Vazyme LFA had 95.9% sensitivity and 96.1% specificity. Along with the increased need for rapid, effective, and affordable point of care tests to help provide meaningful epidemiological data, we demonstrated that the Vazyme LFA performed well on IgG detection but cannot be judged on the performance of IgM detection using PRNT alone. However, our observation of the low IgM-positive rate supported the poor performance of IgM detection of this LFA which led to the disapproval of its Emergency Use Authorization recently.
journal_name
Diagn Microbiol Infect Disjournal_title
Diagnostic microbiology and infectious diseaseauthors
Xie X,Nielsen MC,Muruato AE,Fontes-Garfias CR,Ren Pdoi
10.1016/j.diagmicrobio.2020.115248subject
Has Abstractpub_date
2021-02-01 00:00:00pages
115248issue
2eissn
0732-8893issn
1879-0070pii
S0732-8893(20)30625-8journal_volume
99pub_type
杂志文章abstract：:Fusobacterium nucleatum bacteremia is critical and not well defined. To identify the clinical characteristics and outcomes, we conducted a retrospective review of hospitalized patients from January 2004 to December 2009 at a tertiary center in northern Taiwan. Fifty-seven patients were enrolled. The mean age was 58.1 ...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2010.12.017
更新日期：2011-06-01 00:00:00
abstract：:During March 2005, 24 cases of acute human Chagas disease were detected in Santa Catarina State, southern Brazil, all of them related to the ingestion of Trypanosoma cruzi-contaminated sugar cane juice. Following field studies allowed the isolation of 13 T. cruzi strains from humans, opossums (Didelphis aurita and Did...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2007.07.016
更新日期：2008-01-01 00:00:00
abstract：:We compared the performance of 8 Clostridium difficile enzyme immunoassays to cell cytotoxicity neutralization assay and toxigenic culture. The effect of strain type on assay performance was also examined. There were a total of 71 (14.4%) samples in which C. difficile was recovered; 58 (81.7%) of 71 were toxigenic. Co...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2012.01.005
更新日期：2012-05-01 00:00:00
abstract：:With the development of rapid diagnostic tests in the clinical microbiology laboratory has come an awareness of the importance of rapid results reporting. Clearly, the potential clinical impact of rapid diagnostic tests is dependent on expeditious reporting. Traditional manual reporting systems are encumbered by the n...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/s0732-8893(86)80053-0
更新日期：1986-03-01 00:00:00
abstract：:Antibacterial activity of sulbactam or ampicillin alone and in combination on ampicillin-resistant, beta-lactamase-producing Gram-negative bacteria (Citrobacter freundii and Escherichia coli) was studied. Inhibition of beta-lactamase activity by sulbactam was investigated using intact and disrupted cells. Minimal inhi...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/0732-8893(88)90079-x
更新日期：1988-10-01 00:00:00
abstract：:A patient presented with inflamed hands and Erysipelothrix rhusiopathiae bacteremia. Because a high incidence of endocarditis has been reported with this organism, a transesophageal echocardiogram was obtained, which was normal. Treatment with oral moxifloxacin resolved all manifestations of illness. The association b...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2013.07.002
更新日期：2013-11-01 00:00:00
abstract：:The activities of trovafloxacin and ciprofloxacin against 38 strains of non-beta-lactamase-producing enterococci, resistant to ampicillin, 34 strains susceptible to ampicillin, and 3 vancomycin-resistant enterococci were studied. Trovafloxacin was more active than ciprofloxacin against all the enterococci studied. The...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/s0732-8893(97)00161-2
更新日期：1997-12-01 00:00:00
abstract：:Antimicrobial selection for patients diagnosed with pneumonia is a major therapeutic challenge and dilemma to the clinical practitioner. In the community setting, patients usually receive empiric oral therapy based upon multiple patient risk factors and locally prevalent pathogen susceptibilities. For patients admitte...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/s0732-8893(02)00540-0
更新日期：2003-04-01 00:00:00
abstract：:Using quantitative PCR (qPCR), we differentiated asymptomatic and symptomatic Indian Leishmania donovani infection. qPCR on blood of 40 visceral leishmaniasis, 130 endemic, and 40 non-endemic healthy controls showed 500 times less (P < .0001) parasitemia in asymptomatic compared to the symptomatic ones and threshold o...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2014.01.031
更新日期：2014-09-01 00:00:00
abstract：:Numerous studies have been carried out to determine whether an Epstein-Barr virus (EBV) infection can be considered a risk factor for multiple sclerosis (MS), following the evidence of an increase in IgG response to nuclear antigen-1 (EBNA-1) in both serum and cerebrospinal fluid (CSF) from MS patients. However, the p...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2010.11.013
更新日期：2011-05-01 00:00:00
abstract：:Mycobacterial identification using MALDI-ToF MS (MALDI) has been hindered by inadequate extraction methods. Adaptive Focused Acoustics™ uses concentrated ultrasonic energy to achieve cellular disruption. Using this technology, we developed a rapid mycobacterial inactivation/protein extraction method for MALDI-based id...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2016.06.001
更新日期：2016-11-01 00:00:00
abstract：:The aim of this study was to evaluate the clinical value of partial 16S/18S rRNA gene sequencing with the commercial kit Micro-Dx™ used with the SelectNA™plus instrument on culture-negative samples. A retrospective study of microbiological and clinical data from a 2.5-year period was performed. Assessment of the clini...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2020.115028
更新日期：2020-06-01 00:00:00
abstract：:Increased use of colistin in a clinical setting had resulted in the emergence of colistin-resistant (CoR) Acinetobacter baumannii. Combination therapy has been studied as a new approach to treat infections caused by A. baumannii. Here, we investigated the in vitro antimicrobial synergistic activities of several antimi...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2016.07.017
更新日期：2016-10-01 00:00:00
abstract：:We present a patient with prosthetic valve endocarditis caused by Finegoldia magna (formerly Peptostreptococcus magnus). Blood cultures in the BacT/ALERT and BACTEC 9240 system were negative. We therefore tested different blood culture systems: F. magna grew in the SEPTI-CHEK BHI-S and in the ISOLATOR, but not in the ...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/s0732-8893(03)00091-9
更新日期：2003-09-01 00:00:00
abstract：:Fluconazole susceptibility was tested in 385 clinical yeast isolates (285 Candida albicans, 38 C. glabrata, 31 C. tropicalis, 31 other Candida subsp.) using the agar disk diffusion test. Yeasts were collected from specimens obtained from outpatients (69) and inpatients (intensive care unit: 79 isolates, major burn uni...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/s0732-8893(01)00280-2
更新日期：2001-09-01 00:00:00
abstract：:The diagnosis of tuberculosis (TB) is difficult in children. The pediatricians are waiting for new and rapid tests that are easy to realize and that are performed better than tuberculin skin test (TST). We presented here the evaluation of QuantiFERON-TB Gold In-Tube (QFT-G IT) in the Children Hospital of Nancy. Fifty-...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2009.11.002
更新日期：2010-04-01 00:00:00
abstract：:Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) has emerged as a tool for identifying clinically relevant anaerobes. We evaluated the analytical performance characteristics of the Bruker Microflex with Biotyper 3.0 software system for identification of anaerobes and examined...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2014.02.007
更新日期：2014-06-01 00:00:00
abstract：:Direct determination by pathogen-specific real-time PCR assay for Bacteroides fragilis was compared to culture in major abscess and diabetic foot infection biopsy samples. Real-time PCR resulted in an increased detection rate of 12% for B. fragilis and could improve the detection of B. fragilis in clinical samples. ...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2015.12.017
更新日期：2016-06-01 00:00:00
abstract：:A total of 116 clinical isolates collected in 2003 from a tertiary pediatric hospital and a primary pediatric department in Chicago, IL, were screened for reduced susceptibility to selected fluoroquinolones by disc diffusion. Correlation between reduced susceptibility and point mutations in the quinolone resistance-de...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2008.04.018
更新日期：2008-10-01 00:00:00
abstract：:The first cases of infective endocarditis due to a new species of Bergeyella, Bergeyella cardium sp. nov., are reported. Two strains, 13-07(T) (= JCM 30115(T) = NCCP 15908(T)) and 13-16, were independently isolated from 2 patients in different hospitals in Korea. Initially, the isolates were identified as Brevundimona...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2014.12.001
更新日期：2015-03-01 00:00:00
abstract：:We assessed the performance of the ARCHITECT Toxo IgG, IgM, and IgG Avidity assays against corresponding assays on AxSYM and Vidas using 730 sera from pregnant women. The ARCHITECT Toxo IgG and IgM assays showed a relative sensitivity of 97.5% and 89.9% and a relative specificity of 99.1% and 99.8%, respectively. If I...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2009.07.013
更新日期：2009-11-01 00:00:00
abstract：:In febrile neutropenic patients, prompt empiric antimicrobial intervention is mandatory. Numerous studies have demonstrated the benefit of broad-spectrum beta-lactams active against Gram-negative aerobes as well as against streptococci and Staphylococcus aureus in this setting. With this interventional strategy, a red...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章,评审
doi：10.1016/s0732-8893(99)00024-3
更新日期：1999-07-01 00:00:00
abstract：:The performance of the Gen-Probe Mycobacterium tuberculosis direct (MTD) test was assessed in a laboratory whose specimens were derived from a population with a low prevalence (1.3%) of tuberculosis. A total of 339 specimens from 113 patients were included in the study. Nine of 10 MTD positive samples were culture pos...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/0732-8893(95)00065-i
更新日期：1995-07-01 00:00:00
abstract：:Sulbactam inhibits the hydrolytic activity of several, clinically important beta-lactamases including those produced by anaerobic bacteria. This study was undertaken to determine the effect of sulbactam on the activity of cefoperazone against 250 anaerobic bacteria including 174 isolates belonging to the Bacteroides f...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/0732-8893(90)90054-y
更新日期：1990-01-01 00:00:00
abstract：:We compared the performance of a chromogenic agar medium chromID VRE (bioMérieux, Marcy-l'Etoile, France) designed to recover and identify vancomycin-resistant enterococci (VRE) from clinical specimens with bile esculin azide vancomycin (BEAV) agar. For this study, 120 stool specimens were plated on chromID VRE and BE...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章,多中心研究
doi：10.1016/j.diagmicrobio.2007.06.018
更新日期：2007-12-01 00:00:00
abstract：:Low antibody titers (3 to 6 IU/mL) detected by IMx and AxSYM Toxo IgG assays in serum samples from 264 pregnant women were confirmed by the dye test and a high-sensitivity agglutination test in, respectively, 98.5% and 95.6% of cases, attesting a premunition of these patients. ...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/s0732-8893(98)00060-1
更新日期：1998-09-01 00:00:00
abstract：:We isolated an Escherichia coli O157:H7 strain that was negative for verocytotoxin production, but positive for the vtx2 gene using commercial kits, from an asymptomatic food handler. The laboratory investigations revealed that a 1310-bp insertion sequence, IS1203 variant, was present in the B subunit-coding region of...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2013.06.012
更新日期：2013-10-01 00:00:00
abstract：:Aspergillus endocarditis is a rare event after heart transplantation. We report a case of Aspergillus fumigatus endocarditis after orthotopic heart transplantation. The patient was treated with a combination of voriconazole and caspofungin without valve replacement and survived for 168 days after the diagnosis. Previo...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2008.08.007
更新日期：2008-12-01 00:00:00
abstract：:We report a case of mycotic keratitis caused by Bipolaris oryzae with predisposing trauma from a foreign body. The fungus was identified by sequencing the internal transcribed spacer region, translation elongation factor 1α (TEF1) gene, and partial glyceraldehyde-3-phosphate dehydrogenase (GPDH) gene, and the species ...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2015.11.020
更新日期：2016-05-01 00:00:00
abstract：:An analysis was made on the basis of 5,389 isolates from 5,008 positive blood cultures of the relative yields from 10, 20, and 30 ml of blood. Average yields from cultures of 20 and 30 ml of blood were, respectively, 38 and 61% greater than that from 10 ml of blood. ...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/0732-8893(83)90039-1
更新日期：1983-06-01 00:00:00
