Standardization of Nucleic Acid Tests: the Approach of the World Health Organization.

Abstract:

:The first World Health Organization (WHO) international standards (ISs) for nucleic acid amplification techniques were established two decades ago, with the initial focus on blood screening for three major viral targets, i.e., hepatitis C virus, hepatitis B virus, and human immunodeficiency virus 1. These reference materials have subsequently found utility in the diagnosis and monitoring of a wide range of infectious diseases in clinical microbiology laboratories worldwide. WHO collaborating centers develop ISs and coordinate international studies for their evaluation. The WHO Expert Committee on Biological Standardization is responsible for the endorsement of new standardization projects and the establishment of new and replacement ISs. Potencies of ISs are defined in international units (IU); the reporting in IU for assays calibrated with an IS (or secondary standards traceable to the IS) facilitates comparability of results for different assays and determination of assay parameters such as analytical sensitivities.

journal_name

J Clin Microbiol

authors

Baylis SA,Wallace P,McCulloch E,Niesters HGM,Nübling CM

doi

10.1128/JCM.01056-18

subject

Has Abstract

pub_date

2019-01-02 00:00:00

issue

1

eissn

0095-1137

issn

1098-660X

pii

JCM.01056-18

journal_volume

57

pub_type

杂志文章,评审
  • Sonication of explanted prosthesis combined with incubation in BD bactec bottles for pathogen-based diagnosis of prosthetic joint infection.

    abstract::Prosthetic joint infection (PJI) is a rare but refractory complication of arthroplasty. Accurate identification of pathogens is a key step for successful treatment of PJI, which remains a challenge for clinicians and laboratory workers. We designed a combined culture method with sonication of implants and incubation i...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.02863-14

    authors: Shen H,Tang J,Wang Q,Jiang Y,Zhang X

    更新日期:2015-03-01 00:00:00

  • Mycobacterium avium complex, an emerging pathogen in Massachusetts.

    abstract::We report a study of 1,953 patients whose laboratory records from 1972 through 1983 at the Massachusetts Mycobacteria Reference Laboratory indicated the isolation of Mycobacterium avium complex (MAC) organisms. At least one clinical specimen from each patient during this period exhibited the organism. The incidence of...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.22.1.9-12.1985

    authors: du Moulin GC,Sherman IH,Hoaglin DC,Stottmeier KD

    更新日期:1985-07-01 00:00:00

  • First report of subcutaneous phaeohyphomycosis of the foot caused by Phoma minutella.

    abstract::Phoma minutella, a dematiaceous hyphomycete, was isolated to the exclusion of all other fungi from a subcutaneous inflammatory process on the foot of a farmer undergoing corticosteroid therapy for myasthenia gravis. Isolation was achieved on several nutrient media. Examination of stained smears and sections revealed d...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.25.12.2395-2397.1987

    authors: Baker JG,Salkin IF,Forgacs P,Haines JH,Kemna ME

    更新日期:1987-12-01 00:00:00

  • Enzymatic degradation of urinary indoxyl sulfate by Providencia stuartii and Klebsiella pneumoniae causes the purple urine bag syndrome.

    abstract::The etiology of the purple urine bag syndrome (PUBS), in which the urinary catheter bag of some elderly patients develops intense purple coloration, was studied. The purple was found to be a mixture of indirubin dissolved in the plastic and indigo on its surface. Six patients with PUBS were studied, and Providencia st...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.26.10.2152-2156.1988

    authors: Dealler SF,Hawkey PM,Millar MR

    更新日期:1988-10-01 00:00:00

  • Investigation of apparent false-positive urine latex particle agglutination tests for the detection of group B streptococcus antigen.

    abstract::In our nursery, we identified neonates with positive urine latex particle agglutination (LPA) tests for group B streptococcus (GBS) antigen who did not have corroborating cultural evidence of infection. To investigate the mechanisms underlying these apparent false-positive reactions, we examined the urine LPA test in ...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.27.10.2214-2217.1989

    authors: Harris MC,Deuber C,Polin RA,Nachamkin I

    更新日期:1989-10-01 00:00:00

  • Cholera due to altered El Tor strains of Vibrio cholerae O1 in Bangladesh.

    abstract::We determined the types of cholera toxin (CT) produced by a collection of 185 Vibrio cholerae O1 strains isolated in Bangladesh over the past 45 years. All of the El Tor strains of V. cholerae O1 isolated since 2001 produced CT of the classical biotype, while those isolated before 2001 produced CT of the El Tor biotyp...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.01304-06

    authors: Nair GB,Qadri F,Holmgren J,Svennerholm AM,Safa A,Bhuiyan NA,Ahmad QS,Faruque SM,Faruque AS,Takeda Y,Sack DA

    更新日期:2006-11-01 00:00:00

  • Monoclonal antibody capture enzyme-linked immunosorbent assay for detection of bovine enteric coronavirus.

    abstract::Monoclonal antibodies reactive with three different viral polypeptides were evaluated singly and in combination as the capture antibody(s) in an enzyme-linked immunosorbent assay system for the detection of bovine enteric coronavirus. Similar levels of sensitivity were found for all combinations tested. A sensitive, h...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.19.3.388-393.1984

    authors: Crouch CF,Raybould TJ,Acres SD

    更新日期:1984-03-01 00:00:00

  • First human systemic infection caused by Spiroplasma.

    abstract::Spiroplasma species are organisms that normally colonize plants and insects. We describe the first case of human systemic infection caused by Spiroplasma bacteria in a patient with hypogammaglobulinemia undergoing treatment with biological disease-modifying antirheumatic agents. Spiroplasma turonicum was identified th...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.02841-14

    authors: Aquilino A,Masiá M,López P,Galiana AJ,Tovar J,Andrés M,Gutiérrez F

    更新日期:2015-02-01 00:00:00

  • Multicentric comparative analytical performance study for molecular detection of low amounts of Toxoplasma gondii from simulated specimens.

    abstract::Although screening for maternal toxoplasmic seroconversion during pregnancy is based on immunodiagnostic assays, the diagnosis of clinically relevant toxoplasmosis greatly relies upon molecular methods. A problem is that this molecular diagnosis is subject to variation of performances, mainly due to a large diversity ...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章,多中心研究

    doi:10.1128/JCM.02500-09

    authors: Sterkers Y,Varlet-Marie E,Cassaing S,Brenier-Pinchart MP,Brun S,Dalle F,Delhaes L,Filisetti D,Pelloux H,Yera H,Bastien P

    更新日期:2010-09-01 00:00:00

  • Accuracy of Chlamydia trachomatis antigen detection methods in a low-prevalence population in a primary care setting.

    abstract::We compared a direct fluorescent-antibody stain (DFA) and an enzyme immunoassay (EIA) with a standard cell culture technique for the detection of Chlamydia trachomatis infection in women in an urban family practice setting. We also evaluated a DFA sample in a commercial laboratory to determine the interlaboratory reli...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.28.7.1580-1585.1990

    authors: Gann PH,Herrmann JE,Candib L,Hudson RW

    更新日期:1990-07-01 00:00:00

  • A Panton-Valentine leucocidin (PVL)-positive community-acquired methicillin-resistant Staphylococcus aureus (MRSA) strain, another such strain carrying a multiple-drug resistance plasmid, and other more-typical PVL-negative MRSA strains found in Japan.

    abstract::Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) was collected from children with bullous impetigo in 2003 and 2004. One strain collected in 2003 was Panton-Valentine leucocidin (PVL) positive. In 2004, a multiple-drug-resistant PVL(+) CA-MRSA strain was isolated from an athlete with a cutaneou...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.43.7.3356-3363.2005

    authors: Takizawa Y,Taneike I,Nakagawa S,Oishi T,Nitahara Y,Iwakura N,Ozaki K,Takano M,Nakayama T,Yamamoto T

    更新日期:2005-07-01 00:00:00

  • Rapid Detection of Azole-Resistant Aspergillus fumigatus in Clinical and Environmental Isolates by Use of a Lab-on-a-Chip Diagnostic System.

    abstract::Aspergillus fumigatus has widely evolved resistance to the most commonly used class of antifungal chemicals, the azoles. Current methods for identifying azole resistance are time-consuming and depend on specialized laboratories. There is an urgent need for rapid detection of these emerging pathogens at point-of-care t...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.00843-20

    authors: Yu LS,Rodriguez-Manzano J,Moser N,Moniri A,Malpartida-Cardenas K,Miscourides N,Sewell T,Kochina T,Brackin A,Rhodes J,Holmes AH,Fisher MC,Georgiou P

    更新日期:2020-10-21 00:00:00

  • Identification of newly described Streptococcus pneumoniae serotype 6D by use of the Quellung reaction and PCR.

    abstract::We tested 121 pneumococcal serogroup 6 isolates (including 30 serotype 6C and 24 serotype 6D isolates) by serotype-specific PCR and the Quellung reaction, using "old" and "new" pool B, factor 6b, and new factor 6d antisera. In combination with group B and other factor antisera, factor 6d antiserum can reliably identif...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.00675-10

    authors: Oftadeh S,Satzke C,Gilbert GL

    更新日期:2010-09-01 00:00:00

  • Opportunistic infection of the spleen caused by Aureobasidium pullulans.

    abstract::The mold Aureobasidium pullulans was isolated on several nutrient media from a splenic abscess in a patient with disseminated lymphoma. Examination of stained smears and paraffin sections revealed fungal structures characteristic of this organism. This is the first reported association of A. pullulans with an opportun...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.23.5.828-831.1986

    authors: Salkin IF,Martinez JA,Kemna ME

    更新日期:1986-05-01 00:00:00

  • Efficiency of fine-needle aspiration compared with other sampling techniques for laboratory diagnosis of Buruli ulcer disease.

    abstract::In accordance with recent WHO recommendations, this study evaluates the sensitivities of PCR and microscopy for fine-needle aspiration (FNA) versus techniques involving swabs and punch biopsy specimens and suggests that FNA can replace punch biopsies for nonulcerative lesions and may serve as an alternative for ulcera...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.01549-10

    authors: Herbinger KH,Beissner M,Huber K,Awua-Boateng NY,Nitschke J,Thompson W,Klutse E,Agbenorku P,Assiobo A,Piten E,Wiedemann F,Fleischmann E,Helfrich K,Adjei O,Löscher T,Bretzel G

    更新日期:2010-10-01 00:00:00

  • Detection of St. Louis encephalitis virus antigen in mosquitoes by capture enzyme immunoassay.

    abstract::Surveillance methods that measure St. Louis encephalitis (SLE) virus activity in nature may provide forewarning of its epidemic occurrence in humans. An antigen capture enzyme immunoassay was developed to detect SLE virus in infected mosquitoes. The assay detected purified SLE viral antigen at a concentration of 62 pg...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.25.2.370-376.1987

    authors: Tsai TF,Bolin RA,Montoya M,Bailey RE,Francy DB,Jozan M,Roehrig JT

    更新日期:1987-02-01 00:00:00

  • Lack of characteristic hexagonal surface structure on a newly isolated influenza C virus.

    abstract::The hexagonal surface structure believed to be characteristic for influenza C virus was not initially observed for a newly isolated virus of this type. After a few additional egg passages of the virus, however, the hexagonal structure could be readily seen on many virions. ...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:

    authors: Martin ML,Palmer EL,Kendal AP

    更新日期:1977-07-01 00:00:00

  • Temperate bacteriophages affect pulsed-field gel electrophoresis patterns of Campylobacter jejuni.

    abstract::The recently sequenced genome of Campylobacter jejuni RM1221 revealed the presence of three integrated bacteriophage-like elements. In this study, genes from the first element, a Mu-like bacteriophage, were amplified by PCR and used to probe pulsed-field gels of clinical C. jejuni strains obtained from a waterborne ou...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.01513-06

    authors: Barton C,Ng LK,Tyler SD,Clark CG

    更新日期:2007-02-01 00:00:00

  • A Comprehensive Statistical Framework for Determination of Commutability, Accuracy, and Agreement in Clinical DNAemia Assays.

    abstract::Despite advances in the standardization of quantitative DNAemia tests and efforts to better understand and characterize the performance of reference materials in different assays, it remains unclear how the commutability performance of reference materials is related to intra- and interassay agreement. Building upon pr...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.00963-18

    authors: Tang L,Su Y,Gu Z,Caliendo AM,Pounds S,Hayden RT

    更新日期:2019-01-02 00:00:00

  • Detection of the glmM gene in Helicobacter pylori isolates with a novel primer by PCR.

    abstract::A novel reverse primer (GLM MR1) was designed for detection of the glmM gene in Helicobacter pylori by PCR. The percentage of amplification in clinical isolates using GLM MR1 was 100% for detection of the glmM gene and 86.36% for the ureA gene. The primer designed is useful for the identification of H. pylori. ...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.00461-10

    authors: Espinoza MG,Vazquez RG,Mendez IM,Vargas CR,Cerezo SG

    更新日期:2011-04-01 00:00:00

  • Comparison of BACTEC PLUS blood culture media to BacT/Alert FA blood culture media for detection of bacterial pathogens in samples containing therapeutic levels of antibiotics.

    abstract::Blood culture bottles with antimicrobial removal systems are recommended for patients who develop fever while on antibiotics. This study compared the ability of Becton Dickinson (Sparks, MD) BACTEC PLUS bottles and bioMerieux (Durham, NC) BacT/Alert FA bottles to effectively remove vancomycin, cefoxitin, ceftriaxone, ...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.02064-06

    authors: Flayhart D,Borek AP,Wakefield T,Dick J,Carroll KC

    更新日期:2007-03-01 00:00:00

  • Preparation and use of erythrocyte-globulin conjugates to Lassa virus in reversed passive hemagglutination and inhibition.

    abstract::Conditions were defined for functional covalent coupling of anti-Lassa virus globulins to glutaraldehyde-fixed chicken erythrocytes. Tolylene-2,4-diisocyanate in a reaction mixture containing not more than 0.01 M NaCl produced uniformly good conjugates which were used in reversed passive hemagglutination (RPH) and rev...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.11.6.593-599.1980

    authors: Goldwasser RA,Elliott LH,Johnson KM

    更新日期:1980-06-01 00:00:00

  • Multicenter evaluation of the new Vitek 2 yeast susceptibility test using new CLSI clinical breakpoints for fluconazole.

    abstract::A fully automated antifungal susceptibility test system recently updated to reflect the new species-specific clinical breakpoints (CBPs) of fluconazole for Candida (Vitek 2 AF03 yeast susceptibility test; bioMérieux, Inc., Durham, NC) was compared in three different laboratories with the Clinical and Laboratory Standa...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章,多中心研究

    doi:10.1128/JCM.00658-14

    authors: Pfaller MA,Diekema DJ,Procop GW,Wiederhold NP

    更新日期:2014-06-01 00:00:00

  • Rapid detection and identification of mucormycetes from culture and tissue samples by use of high-resolution melt analysis.

    abstract::We present a method for rapid and simple detection of clinically relevant mucormycetes of the Mucorales order in cultures and clinical samples. This seminested real-time PCR uses mucormycete-specific primers and is followed by species identification using high-resolution melt (HRM) analysis. The method is highly suita...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.01109-10

    authors: Hrncirova K,Lengerova M,Kocmanova I,Racil Z,Volfova P,Palousova D,Moulis M,Weinbergerova B,Winterova J,Toskova M,Pospisilova S,Mayer J

    更新日期:2010-09-01 00:00:00

  • Comparison of in-house real-time quantitative PCR to the Adenovirus R-Gene kit for determination of adenovirus load in clinical samples.

    abstract::In the context of hematopoietic stem cell transplantation, adenovirus infections are associated with relevant mortality and morbidity. Detection of adenovirus DNA by quantitative PCR is the "gold standard" for these patients. A total of 150 samples, namely, 78 whole-blood, 22 cerebrospinal fluid, 24 digestive biopsy, ...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.00976-10

    authors: Jeulin H,Salmon A,Bordigoni P,Venard V

    更新日期:2010-09-01 00:00:00

  • Performance characteristics of recombinant enzyme immunoassay to detect antibodies to human immunodeficiency virus type 1 (HIV-1) and HIV-2 and to measure early antibody responses in seroconverting patients.

    abstract::We investigated the performance of a double-antigen sandwich recombinant enzyme immunoassay (EIA; Abbott Laboratories, North Chicago, Ill.) and compared it with that of a synthetic-peptide-based EIA (Biochem Immunosystems, Montreal, Quebec, Canada) for the detection of human immunodeficiency type 1 (HIV-1) and HIV-2 a...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.34.4.999-1002.1996

    authors: Galli RA,Castriciano S,Fearon M,Major C,Choi KW,Mahony J,Chernesky M

    更新日期:1996-04-01 00:00:00

  • Clinical Performance of Check-Direct CPE, a Multiplex PCR for Direct Detection of bla(KPC), bla(NDM) and/or bla(VIM), and bla(OXA)-48 from Perirectal Swabs.

    abstract::We evaluated the clinical performance of Check-Direct CPE for carbapenemase detection directly from 301 perirectal swabs (258 patients) in a nonoutbreak setting. Culture of a PCR-confirmed, carbapenemase-containing organism, or history of colonization with such organism within the previous 2 weeks, was used as the ref...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.01921-15

    authors: Lau AF,Fahle GA,Kemp MA,Jassem AN,Dekker JP,Frank KM

    更新日期:2015-12-01 00:00:00

  • Point-of-care system for detection of Mycobacterium tuberculosis and rifampin resistance in sputum samples.

    abstract::Early detection of Mycobacterium tuberculosis complex (MTBC) and markers conveying drug resistance can have a beneficial impact on preventive public health actions. We describe here a new molecular point-of-care (POC) system, the Genedrive, which is based on simple sample preparation combined with PCR to detect MTBC a...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.02209-13

    authors: Castan P,de Pablo A,Fernández-Romero N,Rubio JM,Cobb BD,Mingorance J,Toro C

    更新日期:2014-02-01 00:00:00

  • Identification of Exophiala mesophila isolated from treated dental unit waterlines.

    abstract::Members of the genus Exophiala are often difficult to identify to the species level because of their variable morphological appearances. This paper describes the methods used to identify Exophiala mesophila and provides salient differential features for distinguishing other mesophilic members of the genus. ...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/jcm.41.8.3885-3889.2003

    authors: Porteous NB,Grooters AM,Redding SW,Thompson EH,Rinaldi MG,De Hoog GS,Sutton DA

    更新日期:2003-08-01 00:00:00

  • Feasible method for routine surveillance culturing of stools from neutropenic patients.

    abstract::This study was undertaken to develop an accurate, yet inexpensive, method for determining whether the bowel of a neutropenic patient is colonized with bacteria resistant to the antimicrobial agents used in empiric therapy. Selective agar media were prepared in which Mueller-Hinton agar or MacConkey agar were supplemen...

    journal_title:Journal of clinical microbiology

    pub_type: 杂志文章

    doi:10.1128/JCM.20.6.1174-1176.1984

    authors: Smith JA,Sherlock CH,Burdge DR

    更新日期:1984-12-01 00:00:00