Abstract：
:The Clinical Laboratory Improvement Amendments (CLIA 88) to the Clinical Laboratory Improvement Act of 1967 continues to undergo transformation since its implementation more than 2 years ago. The law and its subsequent regulatory modifications were intended to promote high quality in and accurate results from laboratory testing procedures, regardless of the site at which testing occurred. A number of federal regulatory agencies and committees such as the Healthcare Financing Administration, the Clinical Improved Amendments Committee, and the Commission on Laboratory Accreditation, as well as numerous new or modified regulations and requirements have gained importance since CLIA 88 was enacted. In this discussion, components of CLIA 88 that have the greatest impact on clinical microbiology laboratories are presented. In addition, the potential future significance of CLIA 88 are outlined.
journal_name
Diagn Microbiol Infect Disjournal_title
Diagnostic microbiology and infectious diseaseauthors
Chapin K,Baron EJdoi
10.1016/0732-8893(95)00152-2subject
Has Abstractpub_date
1995-09-01 00:00:00pages
35-43issue
1-2eissn
0732-8893issn
1879-0070pii
0732-8893(95)00152-2journal_volume
23pub_type
杂志文章abstract：:This study aimed to characterize recurrent Pseudomonas aeruginosa blood stream infection (BSI). Positive blood cultures for P. aeruginosa were identified over a 3-year period from seven tertiary care hospitals. Patients with recurrent BSI were identified. Extensive epidemiological, clinical and outcome data were obtai...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章,多中心研究
doi：10.1016/j.diagmicrobio.2017.03.001
更新日期：2017-06-01 00:00:00
abstract：:Combination with tazobactam substantially enhanced the activity of piperacillin against routine isolates of staphylococci, various Enterobacteriaceae, Acinetobacter anitratus, and Bacteroides fragilis. Tazobactam enhanced the activity of piperacillin more than fourfold against Pseudomonas aeruginosa spp. harboring eig...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/0732-8893(89)90082-5
更新日期：1989-11-01 00:00:00
abstract：:Dermatophytic mycetoma is an extremely rare subcutaneous mycosis. Here, we report the case of a 6-year-old girl with clinical, histologic, and mycologic findings consistent with a mycetoma of the scalp caused by Microsporum canis. To our knowledge, this is the first report showing the immunologic and immunogenetic fea...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2011.02.003
更新日期：2011-05-01 00:00:00
abstract：:The incidence of VRE has increased dramatically and hematology-oncology patients are at high risk for acquisition of colonization and development of infection. Therefore, we performed a prospective cohort study to determine risk factors for VRE acquisition among hematology-oncology patients. Patients admitted to a sin...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/s0732-8893(02)00392-9
更新日期：2002-07-01 00:00:00
abstract：:In a randomized, multicenter, open-label study, 490 ambulatory adult patients with lower respiratory tract infection (LRTI) were randomized to roxithromycin (ROX) 150 mg b.i.d. orally (n = 244) or amoxicillin plus clavulanic acid (AMX + CA) as 500 mg AMX + 125 mg CA t.i.d orally (n = 24). Clinical results were analyze...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1016/0732-8893(92)90133-e
更新日期：1992-05-01 00:00:00
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-n...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2020.115248
更新日期：2021-02-01 00:00:00
abstract：:Clostridium difficile toxin-positive diarrheal stool specimens submitted to eight Canadian hospital laboratories from 2013 to 2015 were cultured. Polymerase chain reaction ribotyping of isolates was performed using an internationally standardized, high-resolution capillary gel-based electrophoresis protocol and antimi...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2018.01.017
更新日期：2018-06-01 00:00:00
abstract：:A patient with a history of diabetes, coronary artery disease, stroke, previous renal transplantation, and multiple hospital admissions for recurrent pancreatitis was transferred to the hospital from a chronic care facility because of fever and severe epigastric discomfort. At the time of admission, she was receiving ...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/s0732-8893(97)00233-2
更新日期：1998-03-01 00:00:00
abstract：:The aim of the study was to assess of the role of intraoperative cultures taken at the end of major heart surgery (MHS) in the prediction of postoperative mediastinitis (PM) in patients undergoing MHS over a 6-month period in a tertiary university hospital. Just before wound closure, a sample of the sternal border was...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2006.06.012
更新日期：2006-12-01 00:00:00
abstract：:To diagnose Lyme disease, a two-tier testing algorithm is used in which supplemental IgM and IgG immunoblots to detect antibody to Borrelia burgdorferi are reflexively performed if a first-tier assay, such as a whole-cell sonicate-based enzyme immunoassay (WCS EIA), is reactive. Recent data suggest that equal specific...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2018.02.006
更新日期：2018-07-01 00:00:00
abstract：:A nested polymerase chain reaction (PCR) targeting the 56-kDa antigen gene is currently the most commonly used molecular technique for confirmation of scrub typhus and genotyping of Orientia tsutsugamushi. In this study, we have compared the commonly used nested PCR (N-PCR) with a single-step conventional PCR (C-PCR) ...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2013.11.030
更新日期：2014-05-01 00:00:00
abstract：:We conducted a series of polymerase chain reactions (PCRs) in order to detect bacteria (7 species) and viruses (17 species) in middle ear fluid (MEF) and nasopharynx (Nph) of children with acute otitis media (AOM; n=179). Bacterial and viral nucleic acids were detected in MEF of 78.8% and 14.5% patients, respectively....
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2016.02.010
更新日期：2016-05-01 00:00:00
abstract：:Confirmation of the diagnosis is critical to disease control in measles elimination and rubella control programs. In countries with limited infrastructure and laboratory capacity, collection, transport, and testing of venous blood samples may be difficult. We report the adaptation of a commercial enzyme immunoassay fo...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2005.06.017
更新日期：2005-10-01 00:00:00
abstract：:Pseudomonas aeruginosa isolates were collected form a Turkish hospital. Antimicrobial susceptibility was performed using the Vitek 2 Compact system, and 24 isolates were categorized as multidrug resistant (n = 18), extensively-drug resistant (n = 5), or pan-drug resistant (n = 1). PCR and DNA sequence analysis reveale...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2013.12.003
更新日期：2014-03-01 00:00:00
abstract：BACKGROUND:The Clostridium difficile rate in symptomatic patients represents both those with C. difficile infection (CDI) and those with colonization. To predict the extent of CDI overdiagnosis, we compared the asymptomatic colonization rate to the symptomatic positivity rate in hospitalized patients using nucleic acid...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2016.12.014
更新日期：2017-04-01 00:00:00
abstract：:The in vitro activities of HMR 3647, erythromycin A, clarithromycin, azithromycin, roxithromycin, penicillin G, ampicillin, cefuroxime, trimethoprim/sulfamethoxazole, tetracycline, ciprofloxacin, and levofloxacin were determined for 1179 Streptococcus pneumoniae, 1438 Haemophilus influenzae, and 428 Moraxella catarrha...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章,多中心研究
doi：10.1016/s0732-8893(99)00053-x
更新日期：1999-09-01 00:00:00
abstract：:The influence of the pH of urine on the detection of cytomegalovirus (CMV) by the shell vial assay was evaluated. The pH values of 295 urine specimens ranged from 4.7 to 8.5 (mean 6.3) and were not significantly different in culture-positive versus culture-negative samples. None of the urine specimens appeared to be t...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/0732-8893(89)90028-x
更新日期：1989-05-01 00:00:00
abstract：:At our community teaching hospital between August 1994 and August 1995, Candida glabrata accounted for 14% of all Candida isolates and for 31% of urinary Candida isolates. The culture site was urine for 68% of C. glabrata isolates compared to 30% of all Candida isolates (p < 0.001, chi 2). To study the association bet...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/s0732-8893(97)00076-x
更新日期：1997-09-01 00:00:00
abstract：:A rich store of detailed information about antimicrobial resistance is at each medical center in paper files inaccessible to analysis or in electronic files too diverse to support a common analytical software. WHONET puts that information on a personal computer at each center in a file code and format that is the same...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章,评审
doi：
更新日期：1996-08-01 00:00:00
abstract：:We evaluated the performance of the automated BD Phoenix CPO Detect test (BD-CPO test) for detection and Ambler classification of carbapenemases in Enterobacteriaceae, P.aeruginosa and A.baumannii complex. A collection of 287 Gram-negative clinical isolates, with a reduced susceptibility to at least one carbapenem inc...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2019.114911
更新日期：2020-02-01 00:00:00
abstract：:The aim of this study was to evaluate the serum levels of calprotectin and calgranulin C and routine biomarkers in patients with bacterial sepsis (BS). The initial serum concentrations of calprotectin and calgranulin C were significantly higher in patients with BS (n = 66) than in those with viral infections (n = 24) ...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2018.10.006
更新日期：2019-03-01 00:00:00
abstract：:This study aims to identify factors associated with duration of intravenous (IV) and follow-on oral antibiotic therapy for cellulitis in patients treated through outpatient parenteral antimicrobial therapy (OPAT). A retrospective review of episodes of cellulitis treated over a year (January 2018-January 2019) at a lar...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2020.115305
更新日期：2021-01-06 00:00:00
abstract：:An immunoenzymatic test using as antigen purified suspensions of Coxiella burnetti coated by methylglyoxal on microtiter plates was developed. Multiple testing of the same sera gave similar results: two dilutions of serum (1:400 and 1:1600) were used in routine tests. Good agreement between the immunoenzymatic and the...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/0732-8893(86)90146-x
更新日期：1986-02-01 00:00:00
abstract：:The recent development of nucleic acid amplification methodologies has markedly improved our ability to detect very low levels of specific nucleic acids. Amplification techniques have been combined with product detection systems that are designed for high throughput and are automatable. These developments are drastica...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章,评审
doi：10.1016/0732-8893(93)90016-z
更新日期：1993-02-01 00:00:00
abstract：:The accuracy of examination of the Gram-stained direct smear to classify presumptively Gram-negative rods into three morphotype groups, that is, (a) Enteric bacteria, (b) Pseudomonas, and (c) Bacteroides or Haemophilus, was evaluated. Randomly selected clinical strains (4-9) each of Escherichia coli, Klebsiella pneumo...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/0732-8893(91)90032-b
更新日期：1991-05-01 00:00:00
abstract：:Elizabethkingia miricola is a Gram-negative rod that was initially isolated from condensation water of the space station Mir. This is the 1st reported case of human disease caused by this organism. ...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2008.07.015
更新日期：2008-12-01 00:00:00
abstract：:An OXA-181 producing Escherichia coli isolate that went recurrently undetected directly from rectal swab sample using Xpert® Carba-R, was successfully detected using ertapenem supplemented broth enrichment followed by culture-based method. Our data suggest that implementation of culture-based methods plus enrichment m...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2019.114909
更新日期：2020-01-01 00:00:00
abstract：:In vitro and in vivo study results were reviewed from cefmetazole, a "new" parenteral cephamycin. Cefmetazole's spectrum of activity was comparable to that of second-generation cephalosporins, which includes clinical coverage of many Enterobacteriaceae, Staphylococcus spp., streptococci, Haemophilus spp., pathogenic N...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章,评审
doi：10.1016/0732-8893(89)90106-5
更新日期：1989-09-01 00:00:00
abstract：:Serum samples from all patients with culture-confirmed brucellosis including those with chronic disease from Kazakhstan tested positive in the serum agglutination test for titers > or = 1:25 and reacted in the Brucella immunoglobulin M/immunoglobulin G lateral flow assay (LFA) confirming the high sensitivity of these ...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2009.05.002
更新日期：2009-09-01 00:00:00
abstract：:We evaluated the utility of Architect core antigen assay® Abbott Diagnostics (HCVAg) for monitoring patients with HCV infection and compared to HCV-RNA quantification (Cobas Ampliprep TaqMan-Roche Diagnostics). Samples from 262 patients were studied. Mean baseline HCV RNA and HCVAg levels were similar for responders (...
journal_title：Diagnostic microbiology and infectious disease
pub_type： 杂志文章
doi：10.1016/j.diagmicrobio.2017.06.006
更新日期：2017-09-01 00:00:00
