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Results for “Repeatability and Reproducibility”

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PubMed2004

Classification of perioperative histamine-related reactions.

OBJECTIVE: Histamine release may cause anaphylactoid reactions. However, during anaesthesia and surgery especially cardiovascular effects may not be regarded as histamine-related. Therefore, we adapted the classical concept of histamine release reactions to the perioperative situation and validated the new paradigm. METHODS: Elevated plasma histamine (diagnostic gold standard) was correlated to potentially related intraoperative signs and symptoms. The validity, repeatability and sensitivity of the 'gold standard' was tested by ROC analysis in volunteers, who also received H1-/H2-histamine antagonists. Additionally, a dose-response relationship was determined in dogs using the histamine releaser compound 48/80. RESULTS: The 'gold standard' had a sensitivity of 96% (90%-100%) and a specificity of 93% (85%-100%). The reproducibility was proven by repeated injections of histamine. Skin reactions, tachycardia and hypertension were identified as histamine-related diagnostic variables. A dose-response curve of plasma histamine release was created. CONCLUSIONS: The defined 'gold standard' is valid for the diagnosis of histamine-related reactions during anaesthesia and surgery. It may help to identify patients, who could benefit from pre-anaesthetic antihistamine prophylaxis.

Animals↗

PubMedDate not supplied

[Genetic testing for cystic fibrosis: evaluation of the Elucigene CF20 kit in blood and buccal cells].

Routine determination of mutations in cystic fibrosis requires accurate, rapid, reliable and low-cost methods, permitting the simultaneous detection of multiple mutations. The Elucigene CF20 kit developped by Cellmark Diagnostics, uses multiplex ARMS, which allows the screening for 20 CFTR gene mutations (deltaF508, G542X, N1303K, 1717-1G>A, G551D, W1282X, R553X, deltaI507, 1078delT, 2183AA>G, 3849+10kbC>T, R1162X, 621+1G>T, R334W, R347P, 3659delC, R117H, S1251N, E60X, A455E ) in a work day without specific instrumentation. The kit distinguishes between homozygotes and heterozygotes for deltaF508, but not for rare mutations. The kit detects from 68 to 92% of defective alleles in Caucasians. We evaluate the kit in a blind study in two independent laboratories. Thirty blood samples and thirty mouthwash samples from CF patients, carriers and unaffected individuals were analysed by the Elucigene CF20 kit. All the samples were previously analysed by denaturing gradient gel electrophoresis and sequencing. The Elucigene CF20 kit consists of three multiplexes. Each mutiplex contains ARMS specific primers for six to eight mutations and two control reactions. The absence of the upper control fragment indicates that a repeat test is required. We demonstrated a first time amplification rate of 98.3%: of the 60 samples tested, one required a reamplification. Results compared with the reference method demonstrated that in all cases where one or more of the 20 mutations detected by the kit were present in the test set, the kit accurately identified them. Reproducibility was assessed by repeating the analysis of a blood and mouthwash sample five times. Cross reactivity between R117C and R117H, R117P and R117H, R347P and R347H, deltaI507 and deltaF508, G551D and R553X were evaluated. Only a cross reactivity between R347P and R347H was observed. The kit is specially useful for first line study of patients and carrier identification.

Amino Acid Substitution↗

PubMed2002

Reproducibility of a semi-quantitative food frequency questionnaire in Japanese female dietitians.

OBJECTIVE: To examine reproducibility of assessed intake of foods and nutrients according to a semi-quantitative food frequency questionnaire (SQFFQ) in Japanese female dietitians. SUBJECTS AND METHODS: An SQFFQ was self-administered to 106 (21 male and 85 female) Japanese dietitians in Aichi prefecture in autumn 1996 and the same questionnaire was repeated in autumn 1997. Reproducibility was evaluated in terms of consumption of 15 foods and energy and 30 macro- and micro-nutrients based on the SQFFQ from 84 Japanese female dietitians. RESULTS: For intake of foods, Pearson's correlation coefficients (CCs) with log-transformation and energy adjustment (minimum-median-maximum) ranged from 0.35 (beverages)-0.61-0.71 (dairy products). ANOVA intraclass correlation coefficients (ICCs) with log-transformation and energy adjustment ranged from 0.49 (beverages)-0.74-0.82 (dairy products). Spearman's rank CCs with energy adjustment ranged from 0.43 (confectionery)-0.57-0.76 (dairy products). Weighted kappa statistics with energy adjustment ranged from 0.34 (confectionery)-0.49-0.71 (dairy products). For consumption of nutrients, Pearson's CCs with log-transformation and energy adjustment ranged from 0.23 (zinc)-0.55-0.74 (insoluble dietary fiber). ANOVA ICCs with log-transformation and energy adjustment ranged from 0.37 (zinc)-0.70-0.84 (insoluble dietary fiber). Spearman's rank CCs with energy adjustment ranged from 0.25 (zinc)-0.56-0.74 (magnesium). Weighted kappa statistics with energy adjustment ranged from 0.25 (zinc)-0.50-0.68 (insoluble dietary fiber). CONCLUSIONS: Substantially high reproducibility of consumption of foods and nutrients was attained from an SOFFQ self-administered to Japanese female dietitians.

Analysis of Variance↗

PubMed1994

A validation study on the intraobserver reproducibility of transcranial color-coded duplex sonography velocity measurements.

Transcranial color-coded duplex sonography (TCCD) is a new method for the measurement of angle-corrected intracranial blood velocities. The insonation angle represents the most important technical variable affecting Doppler velocimetry. The present study was designed to evaluate the intraobserver reproducibility of TCCD for repeated examinations of blood velocity in the anterior, middle and posterior cerebral, basilar and vertebral arteries. Three examinations were performed by the same examiner in each of 20 healthy volunteers within 10 days, with a minimal interval of 2 days between two subsequent examinations. The observer was blinded to previous results. The reproducibility was evaluated by calculating the correlation coefficient (r) and the coefficient of variance (CV) of the difference between the values obtained from the second and the third examination vs. the first examination. The results showed good reproducibility of TCCD velocity measurements in all examined arteries: for maximal systolic velocity r was 0.80-0.94 (p < 0.001), and CV was 5.5-9.4%; for maximal end-diastolic velocities r was 0.89-0.94 (p < 0.001), and CV was 6.6-12.2%.

Adult↗

PubMed2001

Reproducibility of the insulin tolerance test (ITT) for assessment of growth hormone and cortisol secretion in normal and hypopituitary adult men.

OBJECTIVE: The within subject variability of the insulin tolerance test (ITT) for assessment of growth hormone (GH) status and cortisol reserve has rarely been examined, particularly in patients with hypopituitarism. This becomes important when biochemical criteria are used to determine which adults with hypopituitarism should receive GH and/or cortisol replacement. In the present study we assessed the reproducibility of GH and cortisol responses in repeated ITTs. Baseline insulin-like growth factor 1 (IGF-1) levels were also assessed for reproducibility on each occasion. DESIGN AND PATIENTS: Three consecutive ITTs were performed in seven normal adult men (ages 22-27 years) and two ITTs in 11 men with hypopituitarism and suspected GH deficiency (ages 23-48 years). MEASUREMENTS: Serum GH and IGF-1 were measured by immunoradiometric and cortisol by immunofluorimetric assays. RESULTS: In normal men group peak GH responses did not differ between the three tests. There was no correlation between individual peak values. The within subject peak GH variability was between 4.6 and 59.3%, and the overall variability in 21 tests was 35%. The lowest peak GH concentration was 70 mU/l (27 microg/l). All hypopituitary men had severe GH deficiency (all peak GH concentrations < 4 mU/l (1.5 microg/l) in both tests). There was a highly significant correlation between individual peak GH values (r = 0.95, P < 0.0001). Basal IGF-1-values in normal and hypopituitary men were highly correlated between tests (r = 0.98, P < 0.0001). The overall within subject variability of IGF-1-values was 11.9% in normal and 22.7% in hypopituitary men. In normal men group peak cortisol responses were not different between the three tests. There was a good correlation between individual peak cortisol responses in the three ITTs. The within subject peak cortisol variability (median 8.3%; range 0.7-21.5%) was significantly less than that of GH (P < 0.03) in two of three test comparisons. In hypopituitary men the within subject peak cortisol variability (median 41.6%; range 3.5-92.7%) was significantly greater (P < 0.001) than in normal men. All patients were correctly classified as cortisol deficient or normal in both ITTs. CONCLUSION: The cortisol response to repeated hypoglycaemia is very reproducible in normal men but the GH response is less so. In hypopituitary men the reproducibility of the GH response is good while that of the cortisol response is poor. However, a single ITT did not misclassify hypopituitary patients who are severely GH and/or ACTH deficient and was therefore adequate for clinical decisions regarding GH and/or cortisol replacement. Nevertheless, it remains possible that a single ITT could misclassify some hypopituitary patients with partial GH or ACTH deficiency.

Adrenocorticotropic Hormone↗

PubMed2004

Evaluation of minimally invasive analysis system for cough leak point pressure measurement.

PURPOSE: Leak point pressure (LPP) measurement has become standard in the diagnosis of stress urinary incontinence. Leak point pressure is determined by increasing abdominal pressure, which can be done with a Valsalva maneuver or coughing, that is Valsalva LPP and cough LPP (CLPP). It may be influenced by catheter size, bladder volume and interobserver variability. A new, computerized LPP measuring technique for routine use in daily urodynamic practice was tested at a female unit urodynamic practice to evaluate female urinary incontinence. MATERIALS AND METHODS: A total of 28 female patients with a mean age of 54.07 years (range 23 to 82) and urinary incontinence underwent a new, minimally invasive measurement of the cough leak point. Measurements are made with the patient standing and repeated 3 times per patient. Additionally, parameters of the corresponding leak were recorded simultaneously. All patients underwent new CLPP measurement and a standard, complete urodynamic investigation, including filling cystometry with abdominal LPP and urethral pressure profile at rest. Statistical evaluation was done by linear regression analysis and the correlation coefficients among CLPP, age, standard abdominal LPP and maximum urethral pressure, and among the 3 measurements for each patient. RESULTS: : The assignment of leakage to the pressure signal presented no problem. All CLPP data were reproducible in the 3 repeated measurements per patient. No correlation was seen between CLPP and abdominal LPP or the urethral pressure profile. CONCLUSIONS: The study confirm that the CLPP is a practicable, consistent and minimally invasive method in routine use. Clinical use is easy and reproducible, and only 1 catheter is required for measurement.

Abdomen↗

PubMed2005

Reproducibility and validity of a food frequency questionnaire among Vietnamese in Ho Chi Minh City.

OBJECTIVE: Our objective was to assess the reproducibility and validity of a food frequency questionnaire (FFQ) among individuals living in Ho Chi Minh City, Vietnam. METHODS: A total of 116 food items in our FFQ were selected by ranking food items according to their contribution to the population intake of nutrients, based on multiple 24-hour recalls (24HRs) from 144 participants in July 2001. The FFQ was validated by using three 24HRs for 118 men and women in Ho Chi Minh City, Vietnam in August 2002. The reproducibility of the FFQ was assessed by repeated administration at 7 +/- 3.4 days. RESULTS: The reproducibility study showed that Spearman correlation coefficients, adjusted for energy intake, ranged from 0.47 to 0.72, and that weighted kappa values ranged from 0.42 for lipid to 0.65 for potassium. In the validation study, correlation coefficients, adjusted for energy intake, between the FFQ and the 24HRs ranged from 0.16 (calcium) to 0.45 (retinol). The proportion of subjects classified by the FFQ into the same third as determined by the 24HRs was between 42% and 62%. CONCLUSIONS: This food frequency questionnaire measured the usual intake of major nutrients for Vietnamese adults living in Ho Chi Minh City and its urban area, where dietary patterns are similar to those of the Vietnamese population.

Adult↗

PubMed2006

Counterregulatory deficits occur within 24 h of a single hypoglycemic episode in conscious, unrestrained, chronically cannulated mice.

Hypoglycemia-induced counterregulatory failure is a dangerous complication of insulin use in diabetes mellitus. Controlled hypoglycemia studies in gene knockout models, which require the use of mice, would aid in identifying causes of defective counterregulation. Because stress can influence counterregulatory hormones and glucose homeostasis, we developed glucose clamps with remote blood sampling in conscious, unrestrained mice. Male C57BL/6 mice implanted with indwelling carotid artery and jugular vein catheters were subjected to 2 h of hyperinsulinemic glucose clamps 24 h apart, with a 6-h fast before each clamp. On day 1, blood glucose was maintained (euglycemia, 178 +/- 4 mg/dl) or decreased to 62 +/- 1 mg/dl (hypoglycemia) by insulin (20 mU x kg(-1) x min(-1)) and variable glucose infusion. Donor blood was continuously infused to replace blood sample volume. Baseline plasma epinephrine (32 +/- 8 pg/ml), corticosterone (16.1 +/- 1.8 microg/dl), and glucagon (35 +/- 3 pg/ml) were unchanged during euglycemia but increased significantly during hypoglycemia, with a glycemic threshold of approximately 80 mg/dl. On day 2, all mice underwent a hypoglycemic clamp (blood glucose, 64 +/- 1 mg/dl). Compared with mice that were euglycemic on day 1, previously hypoglycemic mice had significantly higher glucose requirements and significantly lower plasma glucagon and corticosterone (n = 6/group) on day 2. Epinephrine tended to decrease, although not significantly, in repeatedly hypoglycemic mice. Pre- and post-clamp insulin levels were similar between groups. We conclude that counterregulatory responses to acute and repeated hypoglycemia in unrestrained, chronically cannulated mice reproduce aspects of counterregulation in humans, and that repeated hypoglycemia in mice is a useful model of counterregulatory failure.

Animals↗

PubMed2000

Frequent chromosomal instability but no microsatellite instability in hepatocellular carcinomas.

Microsatellite instability (MSI) phenotype, caused by a deficiency of DNA mismatch repair genes, has been detected in a subset of tumors in the gastrointestinal tract. However, it is not clear how MSI is involved in the tumorigenesis of hepatocellular carcinomas (HCC). Results with HCC are controversial, with positive results published with American and European tumors, but negative with Japanese tumors. We report the absence of MSI in 39 Korean HCCs after analysis with 6 mononucleotide- and over 150 dinucleotide-repeat markers. Only one such dinucleotide-repeat (D2S213) exhibited a reproducible shift in mobility, representing a somatic mutation present in only some of the tumor cells. This may be the result of a spontaneous error of replication due to the intrinsic mutability of these unstable sequences and without any connection to true genomic instability. In support of this interpretation, no frameshift mutations were found at the coding repeats of target genes for the microsatellite mutator phenotype including TGF-betaRII, BAX, hMSH3, and hMSH6. In contrast, we observed frequent allelic losses on chromosomes 4q, 8p, 16q, and 17p by the analysis of dinucleotide repeats (microallelotyping), reflecting a high degree of tumor chromosomal instability, which was significantly associated to the tumor differentiation (p=0.036, Fisher's exact test). These results suggest that, unlike chromosomal instability, widespread MSI plays no role in the development or progression of HCC.

Adolescent↗

PubMed2005

Reproducibility of nighttime salivary cortisol and its use in the diagnosis of hypercortisolism compared with urinary free cortisol and overnight dexamethasone suppression test.

BACKGROUND/METHODS: Nighttime salivary cortisol (NSC) has been suggested to be a useful diagnostic test for Cushing's syndrome (CS). In the absence of published data on its day-to-day variability, we assessed the reproducibility of NSC by repeated measurements in healthy volunteers. Its diagnostic performance was compared with 24-h urinary free cortisol (UFC) and 1 mg overnight dexamethasone suppression test in 12 patients with CS, 20 healthy volunteers, 14 referred patients in which CS was excluded or not firmly established, 16 obese patients, and 20 women in late pregnancy. RESULTS: NSC showed a superior reproducibility in healthy volunteers with a low day-to-day variability as reflected by an intraclass correlation coefficient of 0.78. The receiver operating characteristic curve-estimated cutoff of 6.1 nmol/liter (0.22 microg/dl) demonstrated a sensitivity and specificity of 100% (area under the receiver operating characteristic curve, 1.0; 95% confidence interval, 0.94-1.0) in the diagnosis of CS. NSC, 24-h UFC [after adjusting the local laboratory cutoff to 504 nmol/d (183 microg/d)], and the urinary cortisol/creatinine ratio showed a tendency to be superior to 1 mg dexamethasone suppression test in correctly identifying CS. In late pregnancy, the preserved diurnal variation at a higher level of salivary cortisol reduced the specificity of NSC to 75%. CONCLUSION: Based on its remarkable reproducibility, easy noninvasive nature, and at least similar diagnostic performance, NSC appears to be a preferable alternative to 24-h UFC as a first-line screening test for CS. The cutoff values of NSC, 24-h UFC, and urinary cortisol/creatinine ratio have to be carefully adjusted using assay and center-specific reference ranges of sufficiently large populations.

Adult↗

PubMed1999

Determination of tartaric acid in solid wine residues by capillary electrophoresis and indirect UV detection.

Tartaric acid, used in pharmaceuticals and industrial food preparation, is an important by-product of wine preparation. It is produced by wine factories in large quantities and cannot be rejected into the environment. Wineries precipitate tartaric acid using calcium hydroxide and then evaporate the mixture. The raw compact powder obtained, which contains calcium tartarate and a lot of other constituents (sugars, tannins, etc.) is sold to factories which purify tartaric acid. The different analytical methodologies which are used to determine the tartaric acid concentration in the solid wine residues are long and tedious (Goldenberg method, 14 samples per day). They also suffer from poor reproducibility. Some other methods use ion chromatography or solid Fourier transform IR, which are not currently used for such topics. We propose a capillary electrophoresis method, which not only is very quick (2 min of analysis) but also highly reproducible. Finally it provides very simple electropherograms. The intra-day and inter-day repeatability, the inter-person reproducibility and recovery were estimated. They demonstrate the ruggedness of this new method.

Benzoates↗

PubMed2006

Determination of kavalactones in dried kava (Piper methysticum) powder using near-infrared reflectance spectroscopy and partial least-squares regression.

Kava (Piper methysticum Forst F.), or àwa in the Hawaiian language, has been used for thousands of years by the people of the South Pacific Islands, in particular Fiji, Vanuatu, Tonga, and Samoa, for social and ceremonial occasions. Kava has the unique ability to promote a state of relaxation without the loss of mental alertness. Kava recently became part of the herbal pharmacopoeia throughout the United States and Europe because of its anxiolytic properties. The active compounds are collectively called kavalactones (or kava pyrones). The need for a less time-consuming and costly method to determine the concentration of kavalactones in dried kava is urgent. The combination of near-infrared reflectance spectroscopy (NIRS) and partial least-squares (PLS) methods has been found to be a convenient, versatile, and rapid analytical tool for determination of kavalactones in dried kava powder. Calibration equations were developed based on the analyses of 110 samples with variable physical and chemical properties collected over time from Hawaii kava growers and validated by analyses of a set of 12 samples with unknown kavalactones concentration. All six major kavalactones and the total kavalactones were measured using NIRS with accuracy acceptable for commercial use. The NIRS measurements are reproducible and have a repeatability on a par with HPLC methods.

Anti-Anxiety Agents↗

PubMed1999

Variation in short tandem repeats is deeply structured by genetic background on the human Y chromosome.

Eleven biallelic polymorphisms and seven short-tandem-repeat (STR) loci mapping on the nonrecombining portion of the human Y chromosome have been typed in men from northwestern Africa. Analysis of the biallelic markers, which represent probable unique events in human evolution, allowed us to characterize the stable backgrounds or haplogroups of Y chromosomes that prevail in this geographic region. Variation in the more rapidly mutating genetic markers (STRs) has been used both to estimate the time to the most recent common ancestor for STR variability within these stable backgrounds and to explore whether STR differentiation among haplogroups still retains information about their phylogeny. When analysis of molecular variance was used to study the apportionment of STR variation among both genetic backgrounds (i.e., those defined by haplogroups) and population backgrounds, we found STR variability to be clearly structured by haplogroups. More than 80% of the genetic variance was found among haplogroups, whereas only 3.72% of the genetic variation could be attributed to differences among populations-that is, genetic variability appears to be much more structured by lineage than by population. This was confirmed when two population samples from the Iberian Peninsula were added to the analysis. The deep structure of the genetic variation in old genealogical units (haplogroups) challenges a population-based perspective in the comprehension of human genome diversity. A population may be better understood as an association of lineages from a deep and population-independent gene genealogy, rather than as a complete evolutionary unit.

Africa, Northern↗

PubMed2003

Improved high-performance liquid chromatographic method for the pharmacokinetic studies of a novel iron chelator, CP502, in rats.

An improved reverse-phase high-performance liquid chromatographic method (RP-HPLC) for the determination of a novel iron chelator CP502 (1,6-dimethyl-3-hydroxy-4-(1H)-pyridinone-2-carboxy-(N-methyl)-amide hydrochloride) in rat plasma, urine and feces was developed and validated. The separation was performed on a polymeric column using a mobile phase composed of 1mM ethylenediaminetetra-acetic acid disodium salt (EDTA), acetonitrile, methanol and methylene chloride. Separation of CP502 from plasma, urine or feces endogenous compounds was achieved by gradient elution. Retention times of CP502 and its major metabolite (glucuronide) were about 13 and 4 min, respectively. The method was validated in terms of limit of detection (LOD), limit of quantification (LOQ), selectivity (endogenous from plasma, urine or feces), linearity, extraction recovery, robustness (column selection, mobile phase composition, detection mode, internal standard (IS) selection, analyte stability), day-to-day reproducibility and system suitability (repeatability, peak symmetry and resolution). The method is applicable to bioavailability and pharmacokinetic studies of CP502 in rats.

Animals↗

PubMed2005

Reproducibility of lymphoscintigraphy for lymphatic mapping in patients with penile carcinoma.

PURPOSE: We evaluated the reproducibility of lymphoscintigraphy in the assessment of the location and number of sentinel nodes in patients with penile carcinoma. MATERIALS AND METHODS: A total of 20 patients were prospectively included in analysis. Lymphoscintigraphy was performed after intradermal injection of technetium nanocolloid around the tumor or excision scar. We performed 10-minute anterior dynamic imaging, and static anterior and lateral images were obtained at 30 minutes and 2 hours. The following day scintigraphy was repeated after a second injection of the radiolabeled colloid given in an identical fashion, preceded by acquisition of a starting image. An observer evaluated the paired images and count rates were calculated from the images. RESULTS: At least 1 sentinel node was visualized in all patients on the first lymphoscintigram. A total of 56 sentinel nodes were seen in 38 basins. Drainage to both groins was seen in 18 patients. In 1 of these patients drainage to the prepubic area was also observed. There were 2 patients with drainage to 1 groin. The second lymphoscintigram revealed the same drainage pattern in all patients- the same number of nodal basins and number of sentinel nodes were visualized at identical locations. All hotspots that were visualized during the first lymphoscintigram showed an unequivocal increase in radioactivity after repeat injection. Thus, the reproducibility of penile lymphoscintigraphy was 100% (95% CI 85%-100%). The Pearson correlation coefficient of the paired count rates was 0.69 (p <0.0001). CONCLUSIONS: Results of lymphoscintigraphy in patients with penile carcinoma are highly reproducible for assessment of the number and location of sentinel nodes.

Adult↗

PubMed2003

Toward an international standard for PCR-based detection of Escherichia coli O157. Part 1. Assay development and multi-center validation.

As part of a major European research project, a diagnostic PCR assay, including an internal amplification control, was developed and validated in a collaborative trial for the detection of Escherichia coli O157. The assay is based on amplification of sequences of the rfbE O157 gene. The collaborative trial, including 12 international laboratories, was carried out in two phases: phase (a) was performed with identical PCR reagents, including the internal control, provided by the sending laboratory; phase (b) was performed on the same samples and internal control but using in-house PCR reagents of own choice. Phase (a) showed an inclusivity (detection of target strains) of 96.8% and the exclusivity (negative response from nontarget strains) was 100%. The overall performance resulted of phase (a) in an accordance of 98.8, concordance of 98.6, and a concordance odds ratio of 1.11. Phase (b) results showed an accuracy of 100% with all partners and by using different polymerase types and thermocycler models. This indicates that the assay, under consideration as an international standard, was just as reproducible between laboratories, as repeatable within a laboratory. The assay is taken further for validation on carcass-rinse samples.

Animals↗

PubMed1995

First trimester fetal nuchal translucency: problems with screening the general population. 1.

OBJECTIVE: To evaluate the feasibility of measuring first trimester nuchal translucency in an unselected population, to assess the relationship with gestation and maternal age and to measure reproducibility. DESIGN: A prospective observational study. SETTING: University College Hospital, London. SUBJECTS: One thousand and four women attending for a routine first trimester dating scan between eight and thirteen weeks of gestation. Measurements of nuchal translucency were attempted in 1368 (80.3%) and successful in 1127 (82% of attempts). RESULTS: Nuchal translucency is most easily measured at 11 weeks of gestation. If a cut-off of > or = 3 mm is used, 6% of unselected fetuses between eight and thirteen weeks of gestation are classified as abnormal. Nuchal translucency increases with gestational but not maternal age. Reproducibility is poor: by repeating measurements with a different operator, the same operator using a different still image, or the same operator using the same still image, 18.8%, 17.5% or 12.4% of nuchal translucency measurements, respectively, change their classification as normal or abnormal. CONCLUSIONS: If nuchal translucency > or = 3mm were used as an indication for karyotyping, 6% of the normal pregnant population would be screen positive. However, the percentage will vary greatly depending on the gestational age profile of the screened population. The poor reproducibility of nuchal translucency measurement could diminish its usefulness as a screening test for Down's syndrome.

Adult↗

PubMed1996

Counting of apoptotic cells: a methodological study in invasive breast cancer.

Aims-To arrive at a reproducible sampling technique for counting apoptotic cells in tissue sections of invasive breast cancer that can serve as a protocol for further clinical studies.Methods-In 4 mum thick haematoxylin and eosin stained tissue sections of 12 breast cancers, apoptotic cells, recognised by strict morphological criteria, were counted in consecutive fields of vision at x1000 magnification in a marked area in the most poorly differentiated region of tumour. These counts were regarded as the gold standard. Subsequently, in a systematic sampling experiment, the number of fields that had to be counted to derive an acceptable coefficient of variation (CV) was determined. To compare counts at different magnifications, all fields of vision were also counted at x630 and x400. The intra- and inter-observer reproducibility was tested by repeated measurements at these magnifications in 10 systematically selected fields of vision.Results-Apoptosis seemed to be a rare event, affecting, on average, about 1% of tumour cells. Noticeable clustering of apoptotic cells was observed. The systematic sampling experiment showed that at x1000 magnification, the CV was improved by counting up to 20 fields. When comparing x400 and x630 magnifications with the x1000 magnification, the correlation coefficients were 0.88 and 0.87, respectively. However, the lower magnifications yielded lower counts. With regard to reproducibility, the intra-observer correlation coefficient was 0.91 at x630 and 0.76 at x400. The inter-observer correlation coefficient was 0.77 at x630 and 0.68 at x400.Conclusions-Apoptotic cells can be counted readily in haematoxylin and eosin stained tissue sections. However, a systematic sampling protocol must be followed and cells should be counted at a relatively high magnification to obtain acceptable reproducibility. The suggested protocol will permit further correlative and prognostic studies and the monitoring of the effects of treatment.

Journal Article↗