Abstract:
:To establish the effect of a quality control failure on the performance of the LCx-GC nucleic-acid amplification assay for Neisseria gonorrhoeae (Abbott Laboratories, Abbott Park, IL) in the field, we conducted a retrospective analysis comparing the clinical and analytic performance of the recalled lots with those not implicated in the recall. Our analysis revealed no statistically significant differences between recalled lots (n = 8,686 tests) and nonrecalled lots (n = 8,699 tests) with respect to multiple parameters of assay performance, including frequency distribution of patient results (P = .575), prevalence of indeterminate results (P = .245), mean positive control signals (P = .26), and within-run calibrator precision (P = .68). The LCx-GC system's lack of an electronic data storage and retrieval capability prevented assessment of the impact of the quality control failure on the clinical performance of recalled lots, such as the one described herein, from being conducted in real time.
journal_name
Am J Clin Patholjournal_title
American journal of clinical pathologyauthors
Skeate RC,Wahi MM,Hanson KL,Cartwright CPdoi
10.1309/1LD8-LU7Y-FFW7-5WQAsubject
Has Abstractpub_date
2005-06-01 00:00:00pages
809-16issue
6eissn
0002-9173issn
1943-7722pii
1LD8LU7YFFW75WQAjournal_volume
123pub_type
杂志文章abstract::The development of a precise, mathematical relationship between blood pressure and renal microvascular abnormalities would be highly desirable. Such a relationship would require that abnormalities be quantitative on a rational scale. The dominant abnormality in nephrosclerosis occurs in arcuate and cortical arteries o...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/85.3.312
更新日期:1986-03-01 00:00:00
abstract:OBJECTIVES:To examine carbonic anhydrase IX (CAIX), a marker of renal cell carcinoma that recently has been described in malignant effusions. METHODS:Pleural and peritoneal fluids with the following diagnoses-reactive (n = 23), carcinoma (n = 17), and "suspicious for mesothelioma" (n = 4)-were immunostained for CAIX, ...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/AJCP8BJ8CJXUEHZD
更新日期:2014-07-01 00:00:00
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journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/64.5.591
更新日期:1975-11-01 00:00:00
abstract:OBJECTIVES:We postulated that lymph node (LN) harvest and LN size are influenced by immunologic effects. METHODS:To investigate this hypothesis, we performed a retrospective analysis of 170 node-negative colon cancer cases to evaluate the density of intratumoral T lymphocytes (ITLs). CD3- and CD8-positive T cells were...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/aqw074
更新日期:2016-06-01 00:00:00
abstract::RhD determination in pregnant women is critical to facilitate Rh immune globulin prophylaxis for RhD-negative women. A single amino acid change in the RhD antigen can cause epitope loss, giving rise to "partial D" variants. Women with some partial D variants may develop anti-D against the missing epitope after pregnan...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/AJCPSXN9HQ4DELJE
更新日期:2010-09-01 00:00:00
abstract::Pulmonary alveolar proteinosis (PAP) is an uncommon disease in which alveoli are progressively filled with surfactant-related material. Although a definitive diagnosis is usually made by an open lung biopsy, bronchoalveolar lavage (BAL) cytology may play a decisive role in the clinical work-up of these patients, and, ...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/106.4.504
更新日期:1996-10-01 00:00:00
abstract::Three activated partial thromboplastin time (APTT) reagent test systems, General Diagnostics Automated APTT, American Dade Actin FS, and Pacific Hemostasis (Thromboscreen KAPTT) reagent, containing different activators for the APTT assay, were evaluated for their precision and sensitivity to factor deficiencies in the...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/85.1.43
更新日期:1986-01-01 00:00:00
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journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/3J5P-9VJR-UP4U-5RU5
更新日期:2006-05-01 00:00:00
abstract::We studied the beta-catenin immunohistochemical profile in tumors expressing shadow cells: pilomatricoma, 10 cases; calcifying odontogenic cyst, 6 cases; and craniopharyngioma, 9 cases. There was strong membranous, cytoplasmic, and nuclear staining of the immature basaloid cells in all of these tumors. Shadow cells we...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/EALE-G7LD-6W71-67PX
更新日期:2003-11-01 00:00:00
abstract::The authors report the use of cardiac troponin I (cTnI) for the early, noninvasive determination of coronary reperfusion following thrombolytic therapy. Cardiac troponin I, creatine kinase (CK)-MB, and myoglobin concentrations were measured in early serum specimens at 30, 60, and 90 minutes after initiation of therapy...
journal_title:American journal of clinical pathology
pub_type: 临床试验,杂志文章
doi:10.1093/ajcp/105.1.6
更新日期:1996-01-01 00:00:00
abstract::An automated calcium method based on o-cresolphthalein complexone chemistry and designed to be used in conjunction with the Beckman ASTRA systems (Beckman Instruments, Inc., Brea, CA) was evaluated. Day-to-day reproducibility studies yielded coefficients of variation ranging from 1.2 to 3.1%. Linearity was 5.0-15.5 mg...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/82.2.182
更新日期:1984-08-01 00:00:00
abstract::Although red blood cell (RBC) antigen typing by agglutination is generally useful, several situations exist where this approach is difficult or impossible. For example, following a massive transfusion, a patient's residual RBCs are mixed with transfused normal donor RBCs. In this case, typing by hemagglutination prima...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/103.3.353
更新日期:1995-03-01 00:00:00
abstract::Acute exacerbations of idiopathic pulmonary fibrosis/cryptogenic fibrosing alveolitis (IPF/CFA) are rare and typically terminal events, but their relationship to underlying patterns of idiopathic interstitial pneumonias is unknown. We reviewed autopsy material from patients who died of diffuse alveolar damage in the c...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/UVAR-MDY8-FE9F-JDKU
更新日期:2003-05-01 00:00:00
abstract:OBJECTIVES:To examine laser microdissection and mass spectrometry (LMD-MS), which has emerged as a new tool to aid in typing amyloid proteins. RESULTS:ALECT-2 is a potential cause of hepatic amyloidosis best detected by LMD-MS. METHODS:One of the more recently reported proteins is ALECT-2 (leukocyte cell-derived chem...
journal_title:American journal of clinical pathology
pub_type: 杂志文章,评审
doi:10.1309/AJCPCLK54RKXTRDI
更新日期:2014-02-01 00:00:00
abstract::Laboratory Branch Complement Fixation and FIAX (fluorescence immunoassay) were compared for the detection of antibodies to herpes simplex virus and cytomegalovirus in human sera. Of 68 sera with no antibodies to herpes simplex virus by complement fixation, one specimen was positive by FIAX (specificity, 98.6%). Of 75 ...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/75.3.387
更新日期:1981-03-01 00:00:00
abstract:OBJECTIVES:Nucleic acid amplification tests on formalin-fixed, paraffin-embedded (FFPE) tissue specimens enable Mycobacterium tuberculosis complex (MTB) detection and rapid tuberculosis diagnosis in the absence of microbiologic culture tests. We aimed to evaluate the efficacy of different polymerase chain reaction (PCR...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/AJCP2QZRH4ZNPRDD
更新日期:2014-09-01 00:00:00
abstract:OBJECTIVES:To describe four cases of an uncommon type of acalculous cholecystitis/cholangitis characterized by increased intraepithelial lymphocytes within the biliary epithelium. METHODS:Cases were prospectively compiled during regular surgical pathology sign-out. Clinical information was obtained from the electronic...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/AJCP9Q4QWZYYGDNA
更新日期:2015-01-01 00:00:00
abstract::Data from the 1977 College of American Pathologists (CAP) Comprehensive Chemistry Survey and other programs have been analyzed in an interlaboratory comparison of the measurements of serum uric acid. The majority of clinical laboratories utilize some form of phosphotungstic acid (PTA) oxidation-reduction technic for t...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:
更新日期:1979-08-01 00:00:00
abstract::An on-line computer-assisted pathology encoding and reportying system (CAPER) has been developed by the Department of Pathology and Laboratory of Computer Science of the Massachusetts General Hospital for a department of surgical pathology that processes more than 25,000 specimens yearly. CAPER performs clerical funct...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/68.6.715
更新日期:1977-12-01 00:00:00
abstract::The authors analyzed the frequency of immunophenotypic abnormalities in 1,474 cases of routinely fixed, paraffin-embedded B-lineage non-Hodgkin's lymphomas. B-lineage was determined by immunoreactivity for CD20 (L26, 92%); CD45RA (4KB5, an additional 3%) or immunoglobulin (Ig) light chain restriction (remaining 5%). C...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/102.6.825
更新日期:1994-12-01 00:00:00
abstract::Gastric intraepithelial neoplasia (IEN; formerly dysplasia) is an advanced precancerous lesion. Lesions indefinite for IEN mimic the IEN phenotype but lack some morphologic attributes of IEN. Indefinite for IEN lesions may arise in native foveolae (atypical foveolar hyperproliferation [aFH]) or intestinalized glands (...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/AJCPEU41HTGXSJDQ
更新日期:2012-05-01 00:00:00
abstract::Serrated adenomas are the precursors of at least 5.8% of colorectal cancers; otherwise little is known of their clinical significance in comparison with conventional adenomas and hyperplastic polyps. We compared the risk of metachronous lesions in colorectal serrated adenomas, conventional adenomas, and hyperplastic p...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/VBAG-V3BR-96N2-EQTR
更新日期:2005-03-01 00:00:00
abstract::HER2 overexpression and amplification have been studied as a therapeutic and prognostic target in a number of human cancers, including esophageal, gastric, and colorectal adenocarcinomas. However, HER2 status has not been well investigated in primary small intestinal adenocarcinoma, probably because of its rarity. In ...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/AJCPK6QHNNOEMJIM
更新日期:2010-12-01 00:00:00
abstract::Congenital-infantile fibrosarcoma (CIFS) is a relatively indolent sarcoma that should be distinguished from more aggressive spindle cell sarcomas of childhood. CIFSs have been found to have a novel recurrent reciprocal translocation t(12;15)(p13;q25) resulting in the gene fusion ETV6-NTRK3 (ETS variant gene 6; neurotr...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/3H24-E7T7-V37G-AKKQ
更新日期:2001-03-01 00:00:00
abstract:OBJECTIVES:Increased frequency of hyperamylasemia has previously been reported in human immunodeficiency virus (HIV)-positive patients, but studies determined total amylase activity and were performed before the introduction of highly active antiretroviral therapy (HAART). We evaluated the frequency of pancreatic hyper...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/aqv020
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVES:To investigate metastasis associated in colon cancer 1 (MACC1) and MET expression in colorectal adenoma, Tis, early-stage invasive (T1 and T2), and advanced adenocarcinoma with liver metastasis using immunohistochemistry. METHODS:Ninety-three paraffin-embedded colorectal tumor specimens were immunohistochem...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1309/AJCPRH1H5RWWSXRB
更新日期:2013-11-01 00:00:00
abstract:OBJECTIVES:To determine the public health surveillance severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing volume needed, both for acute infection and seroprevalence. METHODS:Required testing volumes were developed using standard statistical methods based on test analytical performance, disease preval...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
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更新日期:2020-07-07 00:00:00
abstract::Previous studies have found that amplification and overexpression of the c-erbB-2 oncogene in mammary ductal adenocarcinomas predicts decreased disease-free or overall survival. Information regarding the prognostic and pathogenetic significance of oncogene amplification has been limited by difficulty obtaining suffici...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/101.4.493
更新日期:1994-04-01 00:00:00
abstract::Estrogen and progesterone receptors were studied in fine-needle aspiration biopsy specimens of 56 patients with primary, recurrent, or metastatic breast carcinoma. The ligands, 17 B-estradiol-6-carboxymethyloxine-bovine serum albumin fluorescein isothiocyanate (FITC-BSA estradiol) and hydroxyprogesterone hemisuccinate...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:10.1093/ajcp/95.1.35
更新日期:1991-01-01 00:00:00
abstract::Our objective was to assess the loss of E-cadherin (EC) as a diagnostic marker or a predictor of prognosis. We stained 276 breast carcinomas with monoclonal antibodies to EC (invasive lobular carcinomas [ILC] and variants, 59; invasive ductal carcinoma and ductal special types [IDC], 204; tubulolobular carcinoma [TLC]...
journal_title:American journal of clinical pathology
pub_type: 杂志文章
doi:
更新日期:2006-03-01 00:00:00