Abstract:
:The cobas human papillomavirus (HPV) test, approved by the FDA in April 2011, is a fully automated assay for the detection of 14 high-risk (hr) HPV genotypes from cervical specimens collected in liquid-based cytology medium using real-time PCR amplification of the L1 gene and TaqMan probes. Results are simultaneously reported as positive or negative for the pooled 12 oncogenic HPV types (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68) from channel 1, with HPV16 and HPV18 genotypes read individually from channels 2 and 3. A fourth channel detects the human β-globin gene as a control for sample adequacy and assay inhibition. To optimize clinical sensitivity and specificity, cutoff values (cycle thresholds [C(T)]) were established for each channel based on the detection of cervical intraepithelial neoplasia grade 2 (CIN2) or greater (≥CIN2). For women aged ≥21 years with cytology results indicating atypical squamous cells of undetermined significance (ASC-US), CT values provided a sensitivity of 90% (95% confidence interval [CI], 81.5% to 94.8%) for the detection of ≥CIN2 and a specificity of 70.5% (95% CI, 68.1% to 72.7%). The analytic sensitivity (limit of detection) ranged from 150 to 2,400 copies/ml, depending on genotype. The analytic specificity, evaluated by comparing the HPV result with a combined comparator of Sanger sequencing and the Qiagen digene HC2 high-risk HPV DNA test (hc2), demonstrated overall positive agreement of 96.3% for 14 hrHPV types in women with ASC-US cytology results who were aged ≥21 years and 86.1% in women with NLIM (negative for intraepithelial neoplasia or malignancy) cytology who were aged ≥30 years. These and other performance validation studies demonstrate that the cobas HPV test is a fully automated and clinically validated robust test.
journal_name
J Clin Microbioljournal_title
Journal of clinical microbiologyauthors
Rao A,Young S,Erlich H,Boyle S,Krevolin M,Sun R,Apple R,Behrens Cdoi
10.1128/JCM.03386-12subject
Has Abstractpub_date
2013-05-01 00:00:00pages
1478-84issue
5eissn
0095-1137issn
1098-660Xpii
JCM.03386-12journal_volume
51pub_type
杂志文章abstract::The cellular fatty acid composition of Brucella canis and Brucella suis was determined by gas-liquid chromatography. The presence of relatively large amounts of a 19-carbon cyclopropane fatty acid in B. suis was a major distinguishing feature between these organisms. The gas-liquid chromatography test for cellular fat...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.14.1.111-112.1981
更新日期:1981-07-01 00:00:00
abstract::Ehrlichia risticii causes an acute infectious disease in horses called Potomac horse fever. To investigate the biological diversity of E. risticii organisms, nine E. risticii isolates derived from the peripheral blood monocytes of clinically sick horses in Ohio and Kentucky during the summers of 1991 and 1993 were com...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.32.12.3026-3033.1994
更新日期:1994-12-01 00:00:00
abstract::Rabies virus found worldwide and prevalent throughout the United States continues to be a public health concern. Direct-fluorescent antibody (DFA) detection remains the gold standard for rabies virus diagnostics. Assessing the utility of a high-throughput molecular platform such as the QIAsymphony SP/AS, in conjunctio...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.01227-15
更新日期:2015-09-01 00:00:00
abstract::DNA colony hybridization with three 18- to 20-base-long synthetic oligonucleotide probes for cholera toxin (CT) was used to screen 12 clinical isolates of Aeromonas hydrophila. Under stringent hybridizing (overnight at 40 degrees C) and washing (1 h at 50 degrees C) conditions, nine strains reacted with the 32P-labele...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.26.1.57-61.1988
更新日期:1988-01-01 00:00:00
abstract::Cell-free and cell-associated human immunodeficiency virus cultures suspended in 10% serum remained infectious for several weeks at room temperature. The stability was further increased when cell-associated virus was suspended in neat serum. When dried onto a glass coverslip, virus remained infectious for several days...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.32.2.571-574.1994
更新日期:1994-02-01 00:00:00
abstract::Crude extracts of Dolichos biflorus can be coupled to polystyrene particles to yield an agglutination reagent for the detection of group C streptococcal antigen extracts. The reagent is relatively inexpensive and simple to prepare and can be employed for the definitive identification of this beta-hemolytic streptococc...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.19.1.83-84.1984
更新日期:1984-01-01 00:00:00
abstract::In the last decade, the global emergence of carbapenem resistance in Enterobacteriaceae has posed great concern to public health. Data concerning the role of environmental contamination in the dissemination of carbapenem-resistant Enterobacteriaceae (CRE) are currently lacking. Here, we aimed to examine the extent of ...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.01992-12
更新日期:2013-01-01 00:00:00
abstract::Restriction endonuclease-generated polynucleotide and synthetically produced oligonucleotide gene probes used in colony hybridization assays proved to be efficient for the detection and differentiation of enterotoxigenic Escherichia coli. To compare their relative efficiencies, these two sets of probes were radiolabel...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.26.11.2275-2278.1988
更新日期:1988-11-01 00:00:00
abstract::We serotyped 222 Pasteurella multocida strains isolated from swine lungs at slaughter. Capsular serotypes A and D were determined by the hyaluronidase sensitivity and acriflavin agglutination tests, respectively. Somatic antigens were determined by gel diffusion against standard antisera. Capsular serotype A was found...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.17.6.1074-1076.1983
更新日期:1983-06-01 00:00:00
abstract::PCR amplification technology for the detection of epizootic hemorrhagic disease virus (EHDV) ribonucleic acid in cell culture and clinical specimens was developed. With oligoribonucleotide primers selected from genome segment 10 of EHDV serotype 1 (EHDV-1), which codes for two nonstructural proteins (NS3 and NS3a), th...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.36.9.2604-2608.1998
更新日期:1998-09-01 00:00:00
abstract::A replicator method for screening Staphylococcus aureus isolates for synergistic hemolytic activity is described. The technique should also be useful for assessing the hemolytic activity of staphylococci and streptococci on different lots or brands of blood agar because the inoculum and the distances between spot inoc...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.21.5.835-837.1985
更新日期:1985-05-01 00:00:00
abstract::Helicobacter pylori strains display remarkable genetic diversity, and the presence of strains bearing the toxigenic vacA s1 allele, a complete cag pathogenicity island (PAI), cagA alleles containing multiple EPIYA phosphorylation sites, and expressing the BabA adhesin correlates with development of gastroduodenal dise...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.00273-09
更新日期:2009-06-01 00:00:00
abstract::Screening for Chlamydia trachomatis infection in men has traditionally been limited to men who present with urethral symptoms, thereby limiting the detection of asymptomatic chlamydia infection in men. In order to effectively screen both symptomatic and asymptomatic men, we evaluated a newly developed polymerase chain...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.31.5.1209-1212.1993
更新日期:1993-05-01 00:00:00
abstract::The accuracy of Vitek MS mass spectrometric identifications was assessed for 206 clinically significant isolates of aerobic Gram-positive bacilli representing 20 genera and 38 species. The Vitek MS identifications were correct for 85% of the isolates (56.3% to the species level, 28.6% limited to the genus level), with...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.03483-13
更新日期:2014-04-01 00:00:00
abstract::The use of 1% unmodified rice starch and 1% horse serum instead of 2% soluble starch and 5% serum in Granada medium is described. These components result in a medium of increased stability, preventing spoilage after a few days of storage at room temperature. ...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.43.4.1989-1991.2005
更新日期:2005-04-01 00:00:00
abstract::During pregnancy, Plasmodium falciparum infection of the placenta frequently occurs in the absence of parasites in peripheral blood. We investigated the abilities of the OptiMAL rapid immunochromatographic strip test for P. falciparum lactate dehydrogenase and species-specific PCR performed on peripheral blood to dete...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/jcm.40.1.155-158.2002
更新日期:2002-01-01 00:00:00
abstract::We report on a case of phaeohyphomycosis caused by Alternaria infectoria in a renal transplant recipient with pulmonary infiltrates and multiple skin lesions. Diagnosis was based on microscopy and culture of the skin lesions. Treatment consisted of a combination of surgical excision and systemic antifungal therapy, fi...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.39.5.1952-1955.2001
更新日期:2001-05-01 00:00:00
abstract::To study whether pathogenic clusters of Borrelia burgdorferi sensu lato strains occur, we typed 136 isolates, cultured from specimens from patients (n = 49) with various clinical entities and from ticks (n = 83) or dogs (n = 4) from different geographic regions, by randomly amplified polymorphic DNA (RAPD) fingerprint...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.36.3.768-776.1998
更新日期:1998-03-01 00:00:00
abstract::A new PCR-reverse dot blot hybridization (RDBH) assay was developed for the rapid identification of Mycobacterium species in clinical isolates. The assay, which targets the 16S rRNA, was evaluated for 27 mycobacterial reference strains and 340 clinical isolates that were simultaneously identified by DNA sequencing and...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.02253-06
更新日期:2007-06-01 00:00:00
abstract::Modern identification techniques at the genomic level have greatly improved the taxonomic knowledge of mycobacteria. In adjunct to nucleic acid sequences, mycobacterial identification has been endorsed by investigation of the lipidic patterns of unique mycolic acids in such organisms. In the present investigation, the...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.39.11.4058-4065.2001
更新日期:2001-11-01 00:00:00
abstract::G3 rotaviruses have been reported rarely in cattle, and none have been characterized. We report the first genomic characterization of a bovine G3 rotavirus, CP-1, which had been biologically characterized in vivo and shown to cause age-independent diarrhea. CP-1 was a G3 rotavirus as its VP7 had 92 to 96% deduced amin...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/jcm.40.3.937-942.2002
更新日期:2002-03-01 00:00:00
abstract::We have previously demonstrated homology between a 181-bp fragment of IS6110 and DNA from mycobacteria other than tuberculosis-causing mycobacteria (MOTT). Genomic DNA from 14 strains of MOTT was digested with PvuII and was hybridized with a probe derived from the 181-bp fragment and the INS1/INS2 international standa...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.35.7.1769-1771.1997
更新日期:1997-07-01 00:00:00
abstract::Between 1991 and 1995, an apparent high rate of Staphylococcus warneri bacteremias at the Royal Children's Hospital, Melbourne, Victoria, Australia, raised the possibility of a virulent nosocomial strain. In a retrospective review of 30 S. warneri bacteremias in children, organisms were viable and verified in 22 episo...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.35.8.2174-2177.1997
更新日期:1997-08-01 00:00:00
abstract::To select a method for detecting methicillin-resistant Staphylococcus aureus (MRSA) in nasal swabs, we compared BD GeneOhm MRSA PCR and various culture media (mannitol salt agar with cefoxitin, MRSASelect, CHROMagar MRSA, and Spectra MRSA). While PCR detection of MRSA was more rapid, MRSASelect and Spectra MRSA demons...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.02256-08
更新日期:2009-07-01 00:00:00
abstract::A cross-reaction between Acinetobacter calcoaceticus and chlamydiae is described. A water-soluble, heat stable, non-dialyzable antigen was extracted from Acinetobacter species by boiling. This antigen fixed complement in the presence of homologous hyperimmune sera from rabbits or guinea pigs and in the presence of het...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.10.6.819-822.1979
更新日期:1979-12-01 00:00:00
abstract::Real-time PCR (rt-PCR) is an important diagnostic tool for the identification of Bordetella pertussis, Bordetella holmesii, and Bordetella parapertussis. Most U.S. public health laboratories (USPHLs) target IS481, present in 218 to 238 copies in the B. pertussis genome and 32 to 65 copies in B. holmesii. The CDC devel...
journal_title:Journal of clinical microbiology
pub_type: 历史文章,杂志文章
doi:10.1128/JCM.02368-14
更新日期:2015-01-01 00:00:00
abstract::The diagnosis of filarial infections among individuals residing in areas where the disease is not endemic requires both strong clinical suspicion and expert training in infrequently practiced parasitological methods. Recently developed filarial molecular diagnostic assays are highly sensitive and specific but have lim...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.01697-10
更新日期:2011-01-01 00:00:00
abstract::Genetic studies of serogroup 6 isolates ofStreptococcus pneumoniaeidentified putative serotype 6E. Although its capsular polysaccharide structure has not been elucidated, putative serotype 6E is described in an increasing number of studies as a potentially new serotype. We show here that SPEC6B, which is widely used a...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.03194-15
更新日期:2016-04-01 00:00:00
abstract::Antibiotic-associated hemorrhagic colitis (AAHC) is associated with Klebsiella oxytoca. This study analyzed whether cytotoxic properties are linked to specific subtypes of K. oxytoca. Klebsiella isolates from stools of AAHC patients, healthy carriers, and diarrhea patients as well as from infections of other organs we...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.01741-09
更新日期:2010-03-01 00:00:00
abstract::Hepatitis B virus (HBV) has eight genotypes which have distinct geographical distributions. Studies comparing differences in the clinical outcomes of infections caused by strains with genotype-related variations in the HBV genome have largely compared genotypes B and C and genotypes A and D but not all four genotypes....
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.42.12.5837-5841.2004
更新日期:2004-12-01 00:00:00