The Overall Impact of Cancer Testing on the United States Clinical Laboratory Industry

Author(s):  
Domenic F. Coletta
1999 ◽  
Vol 123 (4) ◽  
pp. 285-289 ◽  
Author(s):  
Gary V. Doern ◽  
Angela B. Brueggemann ◽  
Michael A. Pfaller ◽  
Ronald N. Jones

Abstract Objective.—To assess the performance of clinical microbiology laboratories in the United States when conducting in vitro susceptibility tests with Streptococcus pneumoniae. Methods.—The results of a nationwide College of American Pathologists Proficiency Survey test sample, in which susceptibility testing of an isolate of S pneumoniae was performed, were assessed with respect to precision and accuracy. Results.—Wide variability was noted among participating laboratories with both minimum inhibitory concentration procedures and disk diffusion susceptibility tests when both methods were applied to S pneumoniae. Despite this high degree of variation, categorical interpretive errors were uncommon. Numerous laboratories reported results for antimicrobial agents that are not recommended by the National Committee for Clinical Laboratory Standards for tests with S pneumoniae. Conclusions.—Current susceptibility testing practices with S pneumoniae in the United States indicate limited precision and a tendency for laboratories to test and report results obtained with antimicrobial agents of questionable therapeutic value against this organism. Continued efforts to standardize susceptibility testing of S pneumoniae in the United States are warranted. In addition, modifications of existing interpretive criteria may be necessary.


Transfusion ◽  
2009 ◽  
Vol 49 (11pt2) ◽  
pp. 2520-2523 ◽  
Author(s):  
Robert Carden ◽  
Kathy Allsbrook ◽  
Richard Thomas

2000 ◽  
Vol 124 (8) ◽  
pp. 1201-1208 ◽  
Author(s):  
Steven J. Steindel ◽  
William J. Rauch ◽  
Marianne K. Simon ◽  
James Handsfield

Abstract Context.—A statistically valid inventory of the distribution, both geographic and by laboratory type, of clinical and anatomical laboratory testing in the United States is needed to assess the impact of the Clinical Laboratory Improvements Amendments of 1988 and to provide information for other health care and public health policy decisions. Objective.—To present initial US laboratory testing volume data compiled by the National Inventory of Clinical Laboratory Testing Services. Design.—Stratified random sample of laboratories performing testing in 1996 with data on the number of laboratory tests performed, identified by method and analyte. Data were collected by field tabulators (moderate- or high-complexity laboratories) or through a mail/telephone survey (waived or provider-performed microscopy laboratories) for each site. Participants.—Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing during 1996. Main Outcome Measure.—Laboratory testing distribution for 1996 in the United States by analyte, method, and specimen type. Results.—An overall response rate of 79% provided data from 757 moderate- or high-complexity laboratories and 1322 waived or provider-performed microscopy laboratories. The estimated total US testing volume for 1996 was 7.25 ± 1.09 billion tests. Laboratories performing complex testing, defined as greater than 16 method/analyte/specimen type combinations, comprised 16% of the US laboratories by survey site, but performed 80% (95% confidence limits, 43% to 100%) of the testing volume. Glucose analysis was the most frequently performed test. Automated hematology and chemistry analyzers were the most frequently used methods. Conclusions.—A statistically valid, consistent survey of the distribution of US laboratory testing was obtained. Simple analysis of these data by laboratory type and geographic region can provide insights into where laboratory testing is performed. The study design allows extensions that will facilitate collection of additional data of importance to public health and medical care delivery.


2002 ◽  
Vol 126 (4) ◽  
pp. 413-415
Author(s):  
Jonathan A. Edlow ◽  
Kathy S. Bruner ◽  
Gary L. Horowitz

Abstract Context.—Diagnosis of subarachnoid hemorrhage is usually established by computed tomographic scanning; however, in a few patients, lumbar puncture to examine the cerebrospinal fluid for erythrocytes and xanthochromia is necessary. Some authorities recommend delaying lumbar puncture by 12 hours following onset of symptoms to ensure sufficient time has elapsed for xanthochromia to develop. This recommendation is based on measuring xanthochromia by spectrophotometry. Our hypothesis was that very few hospital laboratories in the United States use this method. Objective.—To determine the percentage of hospital clinical laboratories that measure for xanthochromia using spectrophotometry. Design, Setting, and Participants.—Mail survey to 3500 hospital clinical laboratory directors (in collaboration with the College of American Pathologists). Surveys were mailed in January 2001 and the results tabulated 1 month later. Participation was voluntary. Main Outcome Measures.—Percentage of hospital clinical laboratories that use spectrophotometry versus visual inspection. Results.—Of the 3500 laboratories surveyed, 2551 (72.9%) responded. Of these, 1944 (76.2%) indicated that they evaluated for xanthochromia. Of the 1952 laboratories that answered the question “How do you report your results?” 1947 (99.7%) reported using visual inspection. Conclusions.—When evaluating for xanthochromia in cerebrospinal fluid, nearly all hospital clinical laboratories in the United States use visual inspection. Given this current reality, the recommendation of delaying lumbar puncture by 12 hours needs to be reassessed.


2016 ◽  
Vol 2 (5) ◽  
pp. 259-267 ◽  
Author(s):  
Ariel Lopez-Chavez ◽  
Anish Thomas ◽  
Moses O. Evbuomwan ◽  
Liqiang Xi ◽  
Guinevere Chun ◽  
...  

Purpose Epidermal growth factor receptor (EGFR) mutations confer sensitivity to EGFR tyrosine kinase inhibitors in patients with advanced non–small-cell lung cancer (NSCLC). There are limited and conflicting reports on the frequency of EGFR mutations in Latinos. Patients and Methods Samples from 642 patients with NSCLC from seven institutions in the United States and Latin America were assessed for EGFR mutations (exons 18 to 21) at Clinical Laboratory Improvement Amendments-certified central laboratories. Results EGFR mutation analysis was successfully performed in 480 (75%) of 642 patients; 90 (19%) were Latinos, 318 (66%) were non-Latino whites, 35 (7%) were non-Latino Asians, 30 (6%) were non-Latino blacks, and seven (2%) were of other races or ethnicities. EGFR mutations were found in 21 (23%) of 90 Latinos with varying frequencies according to the country of origin; Latinos from Peru (37%), followed by the United States (23%), Mexico (18%), Venezuela (10%), and Bolivia (8%). In never-smoker Latinos and Latinos with adenocarcinoma histology, EGFR mutation frequencies were 38% and 30%, respectively. There was a significant difference in the frequency of EGFR mutations among the different racial and ethnic subgroups analyzed (P < .001), with non-Latino Asians having the highest frequency (57%) followed by Latinos (23%), non-Latino whites (19%), and non-Latino blacks (10%). There was no difference between Latinos (23%) and non-Latinos (22%; P = .78) and Latinos and non-Latino whites (P = .37). Patients from Peru had an overall higher frequency of mutations (37%) than all other Latinos (17%), but this difference only exhibited a trend toward significance (P = .058). Conclusion There was no significant difference between the frequency of EGFR mutations in NSCLC in Latinos and non-Latinos.


2004 ◽  
Vol 48 (1) ◽  
pp. 275-280 ◽  
Author(s):  
Fred C. Tenover ◽  
Linda M. Weigel ◽  
Peter C. Appelbaum ◽  
Linda K. McDougal ◽  
Jasmine Chaitram ◽  
...  

ABSTRACT A vancomycin-resistant Staphylococcus aureus (VRSA) isolate was obtained from a patient in Pennsylvania in September 2002. Species identification was confirmed by standard biochemical tests and analysis of 16S ribosomal DNA, gyrA, and gyrB sequences; all of the results were consistent with the S. aureus identification. The MICs of a variety of antimicrobial agents were determined by broth microdilution and macrodilution methods following National Committee for Clinical Laboratory Standards (NCCLS) guidelines. The isolate was resistant to vancomycin (MIC = 32 μg/ml), aminoglycosides, β-lactams, fluoroquinolones, macrolides, and tetracycline, but it was susceptible to linezolid, minocycline, quinupristin-dalfopristin, rifampin, teicoplanin, and trimethoprim-sulfamethoxazole. The isolate, which was originally detected by using disk diffusion and a vancomycin agar screen plate, was vancomycin susceptible by automated susceptibility testing methods. Pulsed-field gel electrophoresis (PFGE) of SmaI-digested genomic DNA indicated that the isolate belonged to the USA100 lineage (also known as the New York/Japan clone), the most common staphylococcal PFGE type found in hospitals in the United States. The VRSA isolate contained two plasmids of 120 and 4 kb and was positive for mecA and vanA by PCR amplification. The vanA sequence was identical to the vanA sequence present in Tn1546. A DNA probe for vanA hybridized to the 120-kb plasmid. This is the second VRSA isolate reported in the United States.


2005 ◽  
Vol 17 (5) ◽  
pp. 436-441 ◽  
Author(s):  
Ricardo F. Rosenbusch ◽  
Joann M. Kinyon ◽  
Michael Apley ◽  
Nathan D. Funk ◽  
Sean Smith ◽  
...  

Antimicrobial therapy continues to be important in reducing losses due to pneumonic forms of Mycoplasma bovis disease in beef and dairy calves. Although M. bovis diseases have been documented as frequent and economically important in the United States, there are no published reports on the antimicrobial activity of approved compounds against US strains. In this study, the authors report on the activity of 9 different antimicrobials against 223 recently recovered isolates of M. bovis. These isolates represent accessions from 5 geographic regions of the United States and were grouped by 4 tissues of origin (milk, respiratory, joint, or ear and eye). A broth microdilution test was used to determine minimum inhibitory concentration (MIC) values by reading redox changes detected in broth with alamarBlue (resazurin) indicator. For each antimicrobial, the median, MIC50, MIC90, mode, and range were calculated, and the values used for comparisons. In the absence of accepted breakpoint values, published MIC cutoff values for animal mycoplasmas as well as Clinical Laboratory Standards Institute interpretive criteria were used as a reference to define in vitro activity. The MIC values from active antimicrobials were found to distribute independently of region of origin of the isolates or of tissue of origin. Enrofloxacin, florfenicol, and spectinomycin were found to be active compounds in vitro. Oxytetracycline and chlortetracycline were active against more than half of the isolates. Very few isolates were inhibited by tilmicosin and none by erythromycin, ampicillin, or ceftiofur. The antimicrobial profiles determined for these US strains were remarkably similar to those reported for European isolates. However, unlike in Europe, there appears to be no diversity of profiles when US isolates are grouped by region or tissue of origin.


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