Evaluation of a SARS-CoV-2 lateral flow assay using the plaque reduction neutralization test.

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.

authors

Xie X,Nielsen MC,Muruato AE,Fontes-Garfias CR,Ren P

doi

10.1016/j.diagmicrobio.2020.115248

subject

Has Abstract

pub_date

2021-02-01 00:00:00

pages

115248

issue

2

eissn

0732-8893

issn

1879-0070

pii

S0732-8893(20)30625-8

journal_volume

99

pub_type

杂志文章
  • Rapid methods in clinical microbiology. Clinical situations in which rapid methods may best be applied.

    abstract::Utilization of rapid microbiologic methods could improve both the quality of patient care and help to reduce patient health care costs through more efficient patient management. Medically urgent situations such as meningitis, endocarditis, bacteremia, some soft tissue infections, ocular infections, and pneumonia in im...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/0732-8893(85)90047-1

    authors: Jorgensen JH

    更新日期:1985-11-01 00:00:00

  • Antimicrobial resistance of Clostridium difficile isolates in a tertiary medical center, Israel.

    abstract::The antimicrobial susceptibilities of 49 Clostridium difficile isolates obtained from patients with C. difficile-associated diarrhea to metronidazole, vancomycin, rifampicin, fusidic acid, doxycycline, and linezolid were determined by the disc diffusion and Etest (Biodisk, Solna, Sweden). Random amplification of polym...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2005.09.008

    authors: Bishara J,Bloch Y,Garty M,Behor J,Samra Z

    更新日期:2006-02-01 00:00:00

  • In vitro activity of l-ofloxacin against norfloxacin-resistant coagulase-negative staphylococci.

    abstract::The in vitro activity of l-ofloxacin was determined against coagulase-negative staphylococci that were induced to norfloxacin resistance. l-Ofloxacin was the most active agent tested with an MIC90 of 4 micrograms/ml compared with greater than 128, 32, and 128 micrograms/ml for norfloxacin, ciprofloxacin, and enoxacin,...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/0732-8893(92)90109-7

    authors: Foleno B,Fu KP

    更新日期:1992-08-01 00:00:00

  • Use of and cost savings with morphologic criteria and the spot indole test as a routine means of identification of Escherichia coli.

    abstract::The use of primary isolation plate colonial morphologic criteria (CMC) of a flat, nonmucoid, lactose-fermenting, gram-negative rod on MacConkey agar and the spot indole (SI) test from the sheep blood agar plate was evaluated as a means for identification of Escherichia coli in comparison to kit (Micro-ID, API-20E) and...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/0732-8893(84)90029-4

    authors: Bale MJ,McLaws SM,Fenn JP,Matsen JM

    更新日期:1984-06-01 00:00:00

  • Application of recombinant fimbrial protein for the specific detection of Salmonella enteritidis infection in poultry.

    abstract::A number of disease outbreaks of Salmonella enterica serotype enteritidis (SE) in humans have been traced to the consumption of SE-contaminated egg and egg products. A rapid, specific, and inexpensive method of detecting SE infection in poultry is necessary to reduce human outbreaks. We evaluated rSEF14 fimbrial antig...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/s0732-8893(98)00091-1

    authors: Rajashekara G,Munir S,Lamichhane CM,Back A,Kapur V,Halvorson DA,Nagaraja KV

    更新日期:1998-11-01 00:00:00

  • Comparison of real-time polymerase chain reaction and conventional biochemical methods for identification of Mycobacterium chelonae-Mycobacterium abscessus group to the species level.

    abstract::The Mycobacterium chelonae-Mycobacterium abscessus group (MCAG) is the most common cause of infections because of rapidly growing mycobacteria. Rapid identification of MCAG to the species level is essential for choosing empiric antibiotic treatment and for public health measures. In this study, we compared the perform...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2010.03.011

    authors: Guarin N,Budvytiene I,Ghafghaichi L,Banaei N

    更新日期:2010-08-01 00:00:00

  • Production of extracellular enzymes and cytotoxicity by Vibrio vulnificus.

    abstract::Thirty-three strains of Vibrio vulnificus of clinical and environmental origin were examined for production of 12 extracellular enzymes of potential importance to the virulence of this bacterium. Strains of Vibrio vulnificus were consistent in their production of protease, mucinase, lipase, chondroitinase, hyaluronida...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/0732-8893(86)90112-4

    authors: Oliver JD,Wear JE,Thomas MB,Warner M,Linder K

    更新日期:1986-07-01 00:00:00

  • Antigen-specific CD4- and CD8-positive signatures in different phases of Mycobacterium tuberculosis infection.

    abstract::Current diagnostic standards for Mycobacterium tuberculosis (MTB) infection do not distinguish between active and latent tuberculosis (TB). To identify specific biomarkers characterizing the different forms of TB infection, we investigated in parallel with the QuantiFERON -TB Gold In-Tube (QFT-IT) the use of flow cyto...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2012.11.023

    authors: Nikolova M,Markova R,Drenska R,Muhtarova M,Todorova Y,Dimitrov V,Taskov H,Saltini C,Amicosante M

    更新日期:2013-03-01 00:00:00

  • Epidemiologic typing of multiply drug-resistant Pseudomonas aeruginosa isolated from an outbreak in an intensive care unit.

    abstract::From June to August 1991, there was an outbreak of Pseudomonas aeruginosa infections in an intensive care unit in a general hospital in Sao Paulo, Brazil. We obtained 14 isolates from 14 patients, 11 from tracheal aspirate, and 3 from surgical wound exudates. These strains were typed by serotyping, pyocin typing, and ...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/0732-8893(93)90063-d

    authors: Sader HS,Pignatari AC,Leme IL,Burattini MN,Tancresi R,Hollis RJ,Jones RN

    更新日期:1993-07-01 00:00:00

  • Infective endocarditis and osteomyelitis caused by Cellulomonas: a case report and review of the literature.

    abstract::Cellulomonas spp. are often believed to be of low virulence and have never been reported as a pathogen causing human disease before. We report the first case of endocarditis caused by Cellulomonas and complicated with osteomyelitis of the lumbar spine in a 78-year-old woman. General weakness and aggravated lower back ...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章,评审

    doi:10.1016/j.diagmicrobio.2009.06.001

    authors: Lai PC,Chen YS,Lee SS

    更新日期:2009-10-01 00:00:00

  • Use of surrogate antimicrobial agents to predict susceptibility to ertapenem.

    abstract::Broth or agar dilution susceptibility test results for Enterobacteriaceae (11,775 strains), anaerobes (2888 strains), staphylococci (2206 strains), Haemophilus spp. (840 strains), group A streptococci (280 strains), group B streptococci (269 strains), Streptococcus pneumoniae (709 strains), and 160 other streptococci ...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/s0732-8893(02)00380-2

    authors: Friedland IR,Isaacs R,Mixson LA,Motyl M,Woods GL

    更新日期:2002-05-01 00:00:00

  • Distribution of Pneumocystis jirovecii in lungs from colonized COPD patients.

    abstract::Pneumocystis jirovecii has been detected in lung tissue from patients with chronic obstructive pulmonary disease (COPD) and is associated with disease severity. The regional distribution of the organism in lungs is unknown, but differences in distribution of Pneumocystis could affect estimates of colonization prevalen...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2011.05.008

    authors: Sivam S,Sciurba FC,Lucht LA,Zhang Y,Duncan SR,Norris KA,Morris A

    更新日期:2011-09-01 00:00:00

  • Trends in frequency and susceptibilities of Candida glabrata bloodstream isolates at a university hospital.

    abstract::The frequency of isolation and antifungal susceptibility patterns to fluconazole and itraconazole were determined for 166 Candida glabrata isolates causing bloodstream infection at a single institution from 1995-2000. Findings demonstrated a trend of increasing resistance to itraconazole among the isolates, but no tre...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/s0732-8893(01)00214-0

    authors: Baddley JW,Smith AM,Moser SA,Pappas PG

    更新日期:2001-03-01 00:00:00

  • Evaluation of four DNA extraction methods for the detection of Mycobacterium avium subsp. paratuberculosis by polymerase chain reaction.

    abstract::Polymerase chain reaction (PCR) has been widely used due to its high specificity, sensitivity, and rapid turn-around time. However, inhibitory factors may be co-extracted with the target nucleic acid that will hinder the performance of PCR. In this study, DNA extraction methods for Mycobacterium avium subsp. paratuber...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2003.08.007

    authors: Chui LW,King R,Lu P,Manninen K,Sim J

    更新日期:2004-01-01 00:00:00

  • Serological and molecular detection of Mycoplasma pneumoniae in children with community-acquired lower respiratory tract infections.

    abstract::This study was designed to evaluate the incidence of Mycoplasma pneumoniae infection in children with community-acquired lower respiratory tract infections (LRTIs). A total of 245 patients 6 months to 12 years of age were investigated for M. pneumoniae employing serological tests, polymerase chain reaction (PCR), nest...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2019.03.010

    authors: Kumar S,Garg IB,Sethi GR

    更新日期:2019-09-01 00:00:00

  • Comparison of 9 different PCR primers for the rapid detection of severe acute respiratory syndrome coronavirus using 2 RNA extraction methods.

    abstract::The sensitivity and specificity of various severe acute respiratory syndrome coronavirus (SARS-CoV) PCR primer and probe sets were evaluated through the use of commercial kits and in-house amplification formats. Conventional and real-time PCR assays were performed using a heat-block thermocycler ABI 9600, the Roche Li...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2005.03.007

    authors: Chui L,Drebot M,Andonov A,Petrich A,Glushek M,Mahony J

    更新日期:2005-09-01 00:00:00

  • High prevalence of virulent Helicobacter pylori strains in symptomatic Bulgarian patients.

    abstract::The aim of the study was to evaluate the prevalence of main virulence genes in Helicobacter pylori strains from 116 patients with peptic ulcers (41 cases) and nonulcer diseases (75) by polymerase chain reaction (PCR) with pure cultures and to compare the results with those by multiplex PCR in 39 H. pylori-positive gas...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2009.04.005

    authors: Boyanova L,Markovska R,Yordanov D,Marina M,Ivanova K,Panayotov S,Gergova G,Mitov I

    更新日期:2009-08-01 00:00:00

  • Bacterial pathogens isolated from patients with skin and soft tissue infections: frequency of occurrence and antimicrobial susceptibility patterns from the SENTRY Antimicrobial Surveillance Program (United States and Canada, 1997). SENTRY Study Group (Nor

    abstract::As part of the SENTRY Antimicrobial Surveillance Program, 1562 bacterial isolates were recovered from hospitalized patients with skin and soft tissue infections (SSTIs) in 30 United States (U.S.) and 8 Canadian medical centers between October and December, 1997. The overall rank order of recovery of the six most commo...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章,多中心研究

    doi:10.1016/s0732-8893(98)00162-x

    authors: Doern GV,Jones RN,Pfaller MA,Kugler KC,Beach ML

    更新日期:1999-05-01 00:00:00

  • Comparison of antibiograms developed for inpatients and primary care outpatients.

    abstract::To support antimicrobial stewardship, some healthcare systems have begun creating outpatient antibiograms. We developed inpatient and primary care outpatient antibiograms for a regional health maintenance organization (HMO) and academic healthcare system (AHS). Antimicrobial susceptibilities from 16,428 Enterococcus, ...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2013.01.026

    authors: McGregor JC,Bearden DT,Townes JM,Sharp SE,Gorman PN,Elman MR,Mori M,Smith DH

    更新日期:2013-05-01 00:00:00

  • Guidelines for serological testing in the diagnosis of acute hepatitis A and B.

    abstract::This study was performed to determine whether elevation of serum transaminases can be used to eliminate unnecessary serological tests to diagnose acute hepatitis A (HAV) and acute hepatitis B (HBV). Serum samples of 1226 patients were tested for HBsAg, anti-HBc (IgM), and anti-HAV (IgM). Acute hepatitis was diagnosed ...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/s0732-8893(98)00141-2

    authors: Chitkara YK,Fontes MD

    更新日期:1999-04-01 00:00:00

  • Comparison of susceptibility results of anaerobic organisms determined by agar dilution method and Sceptor Anaerobe MIC/ID Micro Broth Dilution Panels.

    abstract::A commercial broth microdilution system (Sceptor Anaerobe MIC/ID, BBL) for susceptibility testing of anaerobic bacteria was compared to a reference agar dilution system. Of the 172 organisms tested, only 7% failed to grow sufficiently for testing in the Sceptor system. In 1,590 antibiotic/organism combinations, 86.7% ...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/0732-8893(87)90155-6

    authors: Hussain Z,Lannigan R,Schieven BC,Stoakes L,Groves D

    更新日期:1987-10-01 00:00:00

  • New findings about trichodysplasia spinulosa-associated polyomavirus (TSPyV)--novel qPCR detects TSPyV-DNA in blood samples.

    abstract::A new real-time PCR assay for trichodysplasia spinulosa-associated polyomavirus (TSPyV) DNA detection was designed, and blood samples from kidney transplant recipients and healthy individuals were screened. TSPyV-DNA was not detected in blood from healthy individuals, but 26.8% of kidney recipients presented TSPyV-DNA...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2015.10.011

    authors: Urbano PR,Nali LH,Bicalho CS,Pierrotti LC,David-Neto E,Pannuti CS,Romano CM

    更新日期:2016-02-01 00:00:00

  • Use of boronic acid disk methods to detect the combined expression of plasmid-mediated AmpC beta-lactamases and extended-spectrum beta-lactamases in clinical isolates of Klebsiella spp., Salmonella spp., and Proteus mirabilis.

    abstract::A study using boronic acid (BA), an AmpC enzyme inhibitor, was designed to detect the combined expression of plasmid-mediated AmpC beta-lactamases (pAmpCs) and extended-spectrum beta-lactamases (ESBLs) in bacterial isolates naturally lacking chromosomal ampC genes. A total of 122 Klebsiella spp., Salmonella spp., and ...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2006.08.023

    authors: Song W,Jeong SH,Kim JS,Kim HS,Shin DH,Roh KH,Lee KM

    更新日期:2007-03-01 00:00:00

  • Ceftibuten: a new orally absorbed cephalosporin. In vitro activity against strains from the United Kingdom.

    abstract::The in vitro activity of ceftibuten was studied in 572 bacterial strains and was compared with the activity of other orally administered beta-lactams. Ceftibuten displayed high activity against the Enterobacteriaceae, generally being 16-fold more active than cefuroxime, cefaclor, cephalexin, or amoxicillin-clavulanic ...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/0732-8893(91)90089-x

    authors: Wise R,Andrews JM,Ashby JP,Thornber D

    更新日期:1991-01-01 00:00:00

  • Antibody test for Legionella pneumophila detection.

    abstract::Legionella pneumophila is responsible for Legionnaires' disease (LD). Its detection in both environmental and clinical samples is mainly performed by culture plate method which requires up to 10days to obtain results. Nowadays, there are commercial antibodies against this bacterium, but they have not been tested again...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2017.11.005

    authors: Párraga-Niño N,Quero S,Uria N,Castillo-Fernandez O,Jimenez-Ezenarro J,Muñoz FX,Sabrià M,Garcia-Nuñez M

    更新日期:2018-02-01 00:00:00

  • Development and evaluation of genotypic assays for the detection and characterization of enterotoxigenic Escherichia coli.

    abstract::We developed and evaluated a method to genotypically identify enterotoxigenic Escherichia coli (ETEC) and to characterize these organisms with respect to 18 of 21 known colonization factors (CFs). The method, which is based on polynucleotide DNA-DNA colony hybridization, includes a pooled toxin probe assay to identify...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/s0732-8893(02)00504-7

    authors: Steinsland H,Valentiner-Branth P,Grewal HM,Gaastra W,Mølbak K K,Sommerfelt H

    更新日期:2003-02-01 00:00:00

  • Polymicrobial candidemia.

    abstract::We conducted a retrospective review of the clinical data on patients with polymicrobial candidemia during a nine-year period (1992-2000) at our tertiary care University Hospital. Also, the clinical features of patients with polymicrobial vs monomicrobial candidemia were compared. There were 16 (5.2%) patients with mul...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章,评审

    doi:10.1016/s0732-8893(02)00460-1

    authors: Pulimood S,Ganesan L,Alangaden G,Chandrasekar P

    更新日期:2002-12-01 00:00:00

  • Copper-coated textiles: armor against MDR nosocomial pathogens.

    abstract::Soft surfaces in the health-care setting harbor potentially pathogenic bacteria and fungi that can be transferred to patients and personnel. We evaluated the in vitro antimicrobial efficacy of two types of innovative copper-coated textiles against a variety of nosocomial multi-drug resistant (MDR) pathogens. Five isol...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/j.diagmicrobio.2016.02.015

    authors: Irene G,Georgios P,Ioannis C,Anastasios T,Diamantis P,Marianthi C,Philippe W,Maria S

    更新日期:2016-06-01 00:00:00

  • Epidemiology of macrolide and/or lincosamide resistant Streptococcus pneumoniae clinical isolates with ribosomal mutations.

    abstract::Twenty macrolide and/or lincosamide resistant Streptococcus pneumoniae clinical isolates from various sources with 50S ribosomal mutations were identified. Mutations were identified in the 23S rDNA with substitutions at A2058, A2059, or C2611 and in L4 or L22 ribosomal protein genes. Fourteen were A2059G substitutions...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/S0732-8893(03)00130-5

    authors: Doktor SZ,Shortridge VD,Beyer JM,Flamm RK

    更新日期:2004-05-01 00:00:00

  • Comparison of clindamycin, metronidazole, and penicillin for the treatment of experimental infections in mice caused by beta-lactamase-producing Bacteroides intermedius.

    abstract::Turbid saline suspensions (0.35 ml, approximately 10(9) organisms) of a strain of beta-lactamase-producing Bacteroides intermedius were injected subcutaneously into the right groin of ICR male mice. Therapeutic intraperitoneal doses of clindamycin, metronidazole, or penicillin were administered 4 hr later, and thereaf...

    journal_title:Diagnostic microbiology and infectious disease

    pub_type: 杂志文章

    doi:10.1016/0732-8893(86)90088-x

    authors: Cockerill FR 3rd,Rosenblatt JE,Lee DT,Gay JD

    更新日期:1986-05-01 00:00:00