scholarly journals Long-Term Variability in Immunofluorescence Titer of Antibodies to Nuclear Antigens Observed in Clinical Laboratory Proficiency Testing Surveys

2020 ◽  
Author(s):  
Mark H. Wener ◽  
Susan Fink ◽  
Christine Bashleben ◽  
Stephanie Sindelar ◽  
Michael A. Linden
Keyword(s):  
Proficiency Testing ◽  
Clinical Laboratory ◽  
External Quality Assessment ◽  
Rank Order ◽  
Statistical Significance ◽  
Diagnostic Feature ◽  
Nuclear Antigens ◽  
Survey Results ◽  
Important Diagnostic Feature

Context.— Presence of antibodies to nuclear antigens (ANAs) above a threshold titer is an important diagnostic feature of several autoimmune diseases, yet titers reported vary between laboratories. Proficiency survey results can help clarify factors contributing to the variability. Objective.— To determine the contribution of HEp-2 ANA kits from different manufacturers to the variation in titers, and assess whether the differences between kits are consistent over the long term. Design.— HEp-2 ANA titers reported by laboratories participating in the external quality assessment proficiency testing surveys conducted by the College of American Pathologists between 2008 and 2018 were analyzed. The ANA titers reported for each specimen were ranked according to the kits being used by testing laboratories, and the statistical significance of the differences was determined. Results.— The ANA titer results were strongly influenced by the HEp-2 ANA kit used (P < .001). During the 11 years studied, the rank order of the ANA titer for each kit relative to the other kits was remarkably consistent. The rank of ANA titer for individual ANA patterns observed for each kit was similar to the overall rank of that kit. Conclusions.— Variability in ANA titers was strongly associated with the kits used, and the differences between kits were quite consistent during the 11 years studied. Because the variability is not random, it has the potential to be managed by harmonizing kits, which could lead to improved consistency in reporting ANA titers.

scholarly journals Diagnostic Challenges on the Laboratory Detection of Lupus Anticoagulant

Biomedicines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 844
Author(s):  
Armando Tripodi
Keyword(s):  
Lupus Anticoagulant ◽  
Clinical Laboratory ◽  
External Quality Assessment ◽  
State Of The Art ◽  
Diagnostic Procedures ◽  
External Quality ◽  
Glycoprotein I ◽  
Current State ◽  
Clinical Laboratories

Lupus anticoagulant (LA) is one of the three laboratory parameters (the others being antibodies to either cardiolipin or β2-glycoprotein I) which defines the rare but potentially devastating condition known as antiphospholipid syndrome (APS). Testing for LA is a challenging task for the clinical laboratory because specific tests for its detection are not available. However, proper LA detection is paramount for patients’ management, as its persistent positivity in the presence of (previous or current) thrombotic events, candidate for long term anticoagulation. Guidelines for LA detection have been established and updated over the last two decades. Implementation of these guidelines across laboratories and participation to external quality assessment schemes are required to help standardize the diagnostic procedures and help clinicians for appropriate management of APS. This article aims to review the current state of the art and the challenges that clinical laboratories incur in the detection of LA.

Limitations of Proficiency Testing Under CLIA '67

1992 ◽  
Vol 38 (7) ◽  
pp. 1237-1244 ◽  
Author(s):  
R H Laessig ◽  
S S Ehrmeyer ◽  
B J Lanphear ◽  
B J Burmeister ◽  
D J Hassemer
Keyword(s):  
Health Care ◽  
Quality Assurance ◽  
Proficiency Testing ◽  
Clinical Laboratory ◽  
Health Care Financing ◽  
Clinical Laboratories ◽  
Regulatory Strategy ◽  
Clinical Laboratory Improvement Amendments ◽  
Quality Improvement Tool

Abstract Proficiency testing (PT), recognized as a quality-assurance (QA) and quality-improvement tool, also has become the cornerstone of the Health Care Financing Administration's (HCFA) regulatory strategy under the revised Clinical Laboratory Improvement Act of 1967 (CLIA '67) and the proposed Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Use of PT as a regulatory tool corrupts it for things it can do better. PT as a primary regulatory strategy has severe limitations. We explore the nature of these limitations and their implications for clinical laboratories as they impact on the long-term success of HCFA's approved regulatory PT programs in 1991 and beyond, and CLIA '88 PT, which is to be implemented in 1994.

Taxonomic revision of the genus Cabassous McMurtrie, 1831 (Cingulata: Chlamyphoridae), with revalidation of Cabassous squamicaudis (Lund, 1845)

Zootaxa ◽  
2021 ◽  
Vol 4974 (1) ◽  
pp. 47-78
Author(s):  
ANDERSON FEIJÓ ◽  
TERESA CRISTINA ANACLETO
Keyword(s):  
Taxonomic Revision ◽  
Field Studies ◽  
Diagnostic Feature ◽  
Qualitative And Quantitative ◽  
Living Species ◽  
Previously Treated ◽  
Quantitative Analyses ◽  
Cephalic Shield ◽  
Important Diagnostic Feature

Cabassous comprises armadillos lacking a full osteoderm cover in the tail, justifying its common name naked-tailed armadillos. In the only taxonomic revision of the genus, in 1980, four living species were recognized, including a polytypic taxon with two subspecies. Recent studies have questioned this classification, but a comprehensive taxonomic review is lacking. Here, we revise the taxonomy of the genus Cabassous using complementary morphological approaches and clarify the geographical limits of naked-tailed armadillo species. Based on qualitative and quantitative analyses, we recognize five living species: C. centralis, C. chacoensis, C. squamicaudis, C. unicinctus, and C. tatouay. Most of the species can be easily differentiated using external or cranial traits, except C. centralis and C. unicinctus, which share several morphological features. The scutes pattern on the cephalic shield is an important diagnostic feature in naked-tailed armadillos and can be easily applied in field studies. Cabassous squamicaudis and C. unicinctus were previously treated as subspecies but we show they have conspicuous diagnostic traits, without mixture of characters even in closer contact. Cabassous species can be classified as open-dwellers (C. chacoensis and C. squamicaudis), forest-dwellers (C. centralis and C. unicinctus), or of more generalist habits (C. tatouay). We designate a lectotype for C. unicinctus to preserve its long-term nomenclature use. 

External quality assessment: best practice

2014 ◽  
Vol 67 (8) ◽  
pp. 651-655 ◽  
Author(s):  
David James ◽  
Darren Ames ◽  
Berenice Lopez ◽  
Rachel Still ◽  
Wiliam Simpson ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Quality Assessment ◽  
Proficiency Testing ◽  
Best Practice ◽  
Clinical Laboratory ◽  
External Quality Assessment ◽  
External Quality ◽  
Accredited Laboratories ◽  
Eqa Schemes

There is a requirement for accredited laboratories to participate in external quality assessment (EQA) schemes, but there is wide variation in understanding as to what is required by the laboratories and scheme providers in fulfilling this. This is not helped by a diversity of language used in connection with EQA; Proficiency testing (PT), EQA schemes, and EQA programmes, each of which have different meanings and offerings in the context of improving laboratory quality.We examine these differences, and identify what factors are important in supporting quality within a clinical laboratory and what should influence the choice of EQA programme. Equally as important is how EQA samples are handled within the laboratory, and how the information provided by the EQA programme is used.EQA programmes are a key element of a laboratory's quality assurance framework, but laboratories should have an understanding of what their EQA programmes are capable of demonstrating, how they should be used within the laboratory, and how they support quality. EQA providers should be clear as to what type of programme they provide – PT, EQA Scheme or EQA Programme.

Uncertainty evaluation in clinical chemistry, immunoassay, hematology and coagulation analytes using only external quality assessment data

2018 ◽  
Vol 56 (9) ◽  
pp. 1447-1457 ◽  
Author(s):  
Yanyan Qin ◽  
Rui Zhou ◽  
Wei Wang ◽  
Hongyi Yin ◽  
Yanmin Yang ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Proficiency Testing ◽  
Clinical Laboratory ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
Effective Means ◽  
Specific Antigen ◽  
Plasma Sodium ◽  
External Quality ◽  
Quantitative Measurements

Abstract Background: Measurement uncertainty (MU) is a parameter associated with the result of a measurement that characterizes its dispersion. We report results for estimating MU following the application of a top-down procedure using only proficiency test data to establish uncertainty levels for various analytes. Methods: Data were obtained from 142 laboratories participating in the Beijing Center for Clinical Laboratory (BCCL) proficiency testing/external quality assessment (PT/EQA) schemes. The 24-month study included six selected PT shipments to obtain estimates for 50th percentile (median) and 90th percentile MUs and to compare those estimates to usual analytic goals. The number of laboratory participants varied for each trial. The expanded uncertainty (U) was calculated using a cover factor of k=2 for a confidence interval of 95%. All reproducibility, method and laboratory biases came from the PT/EQA data. Results: The median U (k=2) ranged from 3.2% (plasma sodium, indirect ion selective electrode) to 32.8% (triglycerides, free glycerol blanking) for clinical chemistry analyte means from participants in the same method group. Immunoassay analyte median U results ranged from 11.3% (CA125 tumor marker, Roche) to 33.8% (prostate-specific antigen [PSA], Abbott). The range for median U was 3.5% (red blood cell [RBC], Abx) to 30.3% (fibrinogen [FBG], other) for hematology and coagulation analytes. The MUs for most analytes satisfied quality requirements. Conclusions: The use of PT/EQA data, when available, provides an effective means for estimating uncertainties associated with quantitative measurements. Thus, medical laboratories can calculate their own MUs. Proficiency testing organizers can provide participants with an additional MU estimate using only EQA data, which may be updated at the end of each survey.

scholarly journals A Window Into Clinical Next-Generation Sequencing–Based Oncology Testing Practices

2017 ◽  
Vol 141 (12) ◽  
pp. 1679-1685 ◽  
Author(s):  
Rakesh Nagarajan ◽  
Angela N. Bartley ◽  
Julia A. Bridge ◽  
Lawrence J. Jennings ◽  
Suzanne Kamel-Reid ◽  
...  
Keyword(s):  
Next Generation Sequencing ◽  
Proficiency Testing ◽  
Clinical Laboratory ◽  
Precision Oncology ◽  
Next Generation ◽  
Single Nucleotide Variants ◽  
Molecular Oncology ◽  
Survey Results ◽  
Testing Practices ◽  
Generation Sequencing

Context.— Detection of acquired variants in cancer is a paradigm of precision medicine, yet little has been reported about clinical laboratory practices across a broad range of laboratories. Objective.— To use College of American Pathologists proficiency testing survey results to report on the results from surveys on next-generation sequencing–based oncology testing practices. Design.— College of American Pathologists proficiency testing survey results from more than 250 laboratories currently performing molecular oncology testing were used to determine laboratory trends in next-generation sequencing–based oncology testing. Results.— These presented data provide key information about the number of laboratories that currently offer or are planning to offer next-generation sequencing–based oncology testing. Furthermore, we present data from 60 laboratories performing next-generation sequencing–based oncology testing regarding specimen requirements and assay characteristics. The findings indicate that most laboratories are performing tumor-only targeted sequencing to detect single-nucleotide variants and small insertions and deletions, using desktop sequencers and predesigned commercial kits. Despite these trends, a diversity of approaches to testing exists. Conclusions.— This information should be useful to further inform a variety of topics, including national discussions involving clinical laboratory quality systems, regulation and oversight of next-generation sequencing–based oncology testing, and precision oncology efforts in a data-driven manner.

Gingival Health of Porcelain Laminate Veneered Teeth: A Retrospective Assessment

2019 ◽  
Vol 44 (5) ◽  
pp. 452-458 ◽  
Author(s):  
R Arif ◽  
JB Dennison ◽  
D Garcia ◽  
P Yaman
Keyword(s):  
Repeated Measures ◽  
Gingival Crevicular Fluid ◽  
Statistical Significance ◽  
Fluid Collection ◽  
Gingival Recession ◽  
Gingival Health ◽  
Long Term Effect ◽  
The Mean ◽  
Crevicular Fluid

SUMMARY Statement of Problem: The long-term effect of the presence of porcelain laminate veneers (PLVs) on the health of the surrounding gingival issues is not available in the restorative literature. Purpose: To assess the long-term effect of PLVs on the health of the surrounding gingival tissues. A secondary aim was to correlate gingival crevicular fluid (GCF) scores with clinical parameters used for gingival health assessment in teeth treated with PLVs. Methods and Materials: Patients who received PLVs placed at the Graduate Restorative Clinic within a seven- to 14-year period were recalled for clinical evaluations. Periodontal measurements including gingival index (GI), periodontal pocket depth (PPD), gingival recession (GR), and clinical attachment level (CAL) were measured using a standard probe and indices. Gingival Crevicular Fluid (GCF) was measured with a Periotron machine (Periotron 8000, Oraflow Inc), using Periopaper (Periopaper Gingival Fluid Collection Strip, Oraflow Inc.) for fluid collection. Photographs of any observed clinical defect were taken. Data were tabulated using Excel 2010 (Microsoft Corp). Statistical analysis for all descriptive statistics was performed using SPSS 21 (SPSS Software, IBM Corp.) and Stata SE 13 (Stata Software, StataCorp). Repeated-measures analysis of variance (ANOVA) was done to test for statistical significance of the mean pocket depths between the restored and unrestored surfaces of the veneered teeth. The significance level for all tests was p<0.05. Pearson's correlation coefficient was performed for testing statistical significance between GCF and GI and between GCF and PPD. Results: The frequency distribution of the GI included 47 PLVs (43%) with normal gingiva, 16 (15%) with mild inflammation, and 46 (42%) with moderate inflammation and bleeding on probing. The average PPD on the facial surface of the maxillary and mandibular PLVs was 2.17 mm and 2.16 mm, respectively. On the lingual surface, the average PPD was 2.10 mm for maxillary and 2.22 mm for mandibular PLVs. Gingival recession was seen in 27% of the evaluated PLVs. The repeated-measures ANOVA revealed p≥0.136, showing no statistical difference in the mean pocket depths between restored facial and unrestored lingual surfaces of the veneered teeth. A moderate correlation (r=0.407) was found between GCF and GI, which was significant at p<0.001. No correlation (r=0.124) was found between GCF and PPD, which was not significant at p=0.197. Conclusions: Gingival response to the evaluated PLVs was in the satisfactory range, with overall GI scores ranging between normal and moderate inflammation, pocket depths ranging from 1 to 2 mm, and recession present in 27% of the evaluated PLVs. No statistically significant difference was found between the mean pocket depths of the restored and unrestored surfaces of veneered teeth (p≥0.136). A moderate correlation was found between GCF and GI.

Predictors of Faster Decline of Residual Renal Function in Taiwanese Peritoneal Dialysis Patients

2008 ◽  
Vol 28 (3_suppl) ◽  
pp. 191-195 ◽  
Author(s):  
Chia-Te Liao ◽  
Chih-Chung Shiao ◽  
Jenq-Wen Huang ◽  
Kuan-Yu Hung ◽  
Hsueh-Fang Chuang ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Renal Function ◽  
Peritoneal Dialysis ◽  
Clinical Laboratory ◽  
Statistical Significance ◽  
Univariate Analysis ◽  
Residual Renal Function ◽  
Measure Data ◽  
Chi Square ◽  
Artery Disease

⋄ Objective Loss of residual renal function (RRF) in peritoneal dialysis (PD) patients is a powerful predictor of mortality. The present study was conducted to determine the predictors of faster decline of RRF in PD patients in Taiwan. ⋄ Methods The study enrolled 270 patients starting PD between January 1996 and December 2005 in a single hospital in Taiwan. We calculated RRF as the mean of the sum of 24-hour urea and creatinine clearance. The slope of the decline of residual glomerular filtration rate (GFR) was the main outcome measure. Data on demographic, clinical, laboratory, and treatment parameters; episodes of peritonitis; and hypotensive events were analyzed by Student t-test, Mann–Whitney U-test, and chi-square, as appropriate. All variables with statistical significance were included in a multivariate linear regression model to select the best predictors ( p < 0.05) for faster decline of residual GFR. ⋄ Results All patients commencing PD during the study period were followed for 39.4 ± 24.0 months (median: 35.5 months). The average annual rate of decline of residual GFR was 1.377 ± 1.47 mL/min/m2. On multivariate analysis, presence of diabetes mellitus ( p < 0.001), higher baseline residual GFR ( p < 0.001), hypotensive events ( p = 0.001), use of diuretics ( p = 0.002), and episodes of peritonitis ( p = 0.043) independently predicted faster decline of residual GFR. Male sex, old age, larger body mass index, and presence of coronary artery disease or congestive heart failure were also risk factors on univariate analysis. ⋄ Conclusions Our results suggested that diabetes mellitus, higher baseline residual GFR, hypotensive events, and use of diuretics are independently associated with faster decline of residual GFR in PD patients in Taiwan.

scholarly journals Long-Term Cryopreservation Does Not Affect Quality of Peripheral Blood Stem Cell Grafts: A Comparative Study of Native, Short-Term and Long-Term Cryopreserved Haematopoietic Stem Cells

2021 ◽  
Vol 30 ◽  
pp. 096368972110360
Author(s):  
Daniel Lysak ◽  
Michaela Brychtová ◽  
Martin Leba ◽  
Miroslava Čedíková ◽  
Daniel Georgiev ◽  
...  
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
Statistical Significance ◽  
Extended Period ◽  
High Dose ◽  
Atp Production ◽  
Cd34 Cells ◽  
Negative Effect

Cryopreserved haematopoietic progenitor cells are used to restore autologous haematopoiesis after high dose chemotherapy. Although the cells are routinely stored for a long period, concerns remain about the maximum storage time and the possible negative effect of storage on their potency. We evaluated the effect of cryopreservation on the quality of peripheral stem cell grafts stored for a short (3 months) and a long (10 years) period and we compared it to native products.The viability of CD34+ cells remained unaffected during storage, the apoptotic cells were represented up to 10% and did not differ between groups. The clonogenic activity measured by ATP production has decreased with the length of storage (ATP/cell 1.28 nM in native vs. 0.63 in long term stored products, P < 0.05). Only borderline changes without statistical significance were detected when examining mitochondrial and aldehyde dehydrogenase metabolic activity and intracellular pH, showing their good preservation during cell storage. Our experience demonstrates that cryostorage has no major negative effect on stem cell quality and potency, and therefore autologous stem cells can be stored safely for an extended period of at least 10 years. On the other hand, long term storage for 10 years and longer may lead to mild reduction of clonogenic capacity. When a sufficient dose of stem cells is infused, these changes will not have a clinical impact. However, in products stored beyond 10 years, especially when a low number of CD34+ cells is available, the quality of stem cell graft should be verified before infusion using the appropriate potency assays.

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