Comparison of Abbott RealTime genotype II, GeneMatrix restriction fragment mass polymorphism and Sysmex HISCL HCV Gr assays for hepatitis C virus genotyping
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Abstract Background: Hepatitis C virus (HCV) genotype is a predictive marker for treatment response. We sequentially evaluated the performances of two nucleic acid amplification tests (NAATs) and one serology assay for HCV genotype: Abbott RealTi me genotype II (RealTi me II), GeneMatrix restriction fragment mass polymorphism (RFMP), and Sysmex HISCL HCV Gr (HISCL Gr). Methods: We examined 281 clinical samples with three assays. The accuracy was assessed using the HCV Genotype Performance Panel PHW204 (SeraCare Life Sciences) for two NAATs. Discrepant cases were re-genotyped by the Versant HCV v.2.0 (line probe 2.0) assay. Results: With the RealTi me II assay, clinic samples were analyzed as follows: genotypes 1b (43.1%), 2 (40.2%), 1 subtypes other than 1a and 1b (12.5%), 3 (1.8%), 4 (1.4%), 1a (0.7%), 6 (0.4%), and mixed (1.1%). The RealTi me II and RFMP assays showed a type concordance rate of 97.5% (274/281) (κ=0.80) and no significant discordance (p=0.25). Both assays accurately genotyped all samples in the Performance Panel by the subtype level. The HISCL Gr assay showed concordance rates of about 91% (κ<0.40) and statistically significant discordances with two NAATs (p<0.05). In confirmation tests, the results of RFMP assay were the most consistent with those of Versant 2.0 assay. Conclusions: The three HCV assays provided genotyping and serotyping results with good concordance rates. The two NAATs (RealTi me II and RFMP) showed comparable performance and good agreement. However, the results of the HISCL Gr assay showed statistically significant differences with those of the NAATs.Keywords:
Concordance
The TRUGENE HCV 5'NC genotyping kit (GeneLibrarian modules 3.1.1 and 3.1.2) and VERSANT HCV genotyping assay were compared by using 96 hepatitis C virus (HCV) RNA-positive patient specimens, including HCV genotypes 1, 2, 3, 4, 5, 6, and 10. The TRUGENE HCV 5'NC genotyping kit (GeneLibrarian module 3.1.2) yielded the most accurate genotyping results.
Hepatitis C
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Objectives A new molecular test for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) (GeneXpert CT/NG) has been demonstrated to be as accurate as conventional nucleic acid amplification tests (NAAT), but performance has not been evaluated in routine primary care, performed at the point of care by clinicians. We aimed to examine its diagnostic performance when used by clinicians in remote community health services in Australia with high prevalences of CT and NG infection. The trial was registered with the Australian and New Zealand Clinical Trials Registry (#12613000808741) Methods At 12 health services, training was provided to 99 clinicians in the use of the GeneXpert CT/NG assay who tested specimens from all patients undergoing STI screening. Specimens were also sent in parallel for conventional laboratory-based NAATs and the concordance of results was evaluated. Results Clinicians conducted 2486 tests: CT concordance was 99.4% (95% CI 99.1 to 99.7) with a positive concordance of 98.6% (95% CI 95.9 to 99.7) and negative concordance of 99.5% (95% CI 99.1 to 99.8); NG concordance was 99.9% (95% CI 99.7 to 100.0) with a positive concordance of 100.0% (95% CI 97.5 to 100.0) and negative concordance of 99.9% (95% CI 99.7 to 100.0). Conclusions In this first study reporting routine point-of-care use of GeneXpert CT/NG by primary care clinicians, we found excellent concordance with conventional NAATs. The use of the GeneXpert CT/NG at the point of care could potentially transform management and control of these infections in many endemic settings, including low/middle-income countries.
GeneXpert MTB/RIF
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Medication Reconciliation
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Dna testing
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Delineating patients’ health profiles is essential to allow for a proper comparison between medical care and its results in patients with comorbidities. The aim of this work was to evaluate the concordance of health profiles outlined by ward doctors and by epidemiologists and the effectiveness of training interventions in improving the concordance. Between 2018 and 2021, we analyzed the concordance between the health profiles outlined by ward doctors in a private hospital and those outlined by epidemiologists on the same patients’ medical records. The checks were repeated after training interventions. The agreement test (Cohen’s kappa) was used for comparisons through STATA. The initial concordance was poor for most categories. After our project, the concordance improved for all categories of CIRS. Subsequently, we noted a decline in concordance between ward doctors and epidemiologists for CIRS, so a new training intervention was needed to improve the CIRS profile again. Initially, we found a low concordance, which increased significantly after the training interventions, proving its effectiveness.
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Although some scholars suggest that racial/ethnic concordance between physicians and patients will do much to eliminate disparities in medical care, the evidence for concordance effects is mixed. Using nationally representative data with an oversample of blacks and Latinos, this study examines a variety of topics, including beliefs about and preferences for concordance, the effects of concordance on patient experiences, and interactions between expectations and experiences. The results point to the limited effects of concordance in general but illuminate for whom concordance matters most. The results encourage more nuanced and contingent theories. They suggest that racial/ethnic concordance holds little salience in the minds of most black and Latino patients and that discordance has little effect. Nevertheless, there is some evidence that concordance has a positive effect among those who prefer concordance-thus the apparent effects of concordance might reflect the effects of patient choice more than concordance per se. The conclusion sketches policy implications, including the merits of promoting concordance among targeted groups of patients, even in the absence of overall effects on disparities.
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ABSTRACT The combination of preventive vaccination and diagnostic typing of viral isolates from patients with clinical poliomyelitis constitutes our main protective shield against polioviruses. The restriction fragment length polymorphism (RFLP) adaptation of the reverse transcriptase (RT)-PCR methodology has advanced diagnostic genotyping of polioviruses, although further improvements are definitely needed. We report here on an improved RFLP procedure for the genotyping of polioviruses. A highly conserved segment within the 5′ noncoding region of polioviruses was selected for RT-PCR amplification by the UC 53 -UG 52 primer pair with the hope that it would be most resistant to the inescapable genetic alteration-drift experienced by the other segments of the viral genome. Complete inter- and intratypic genotyping of polioviruses by the present RFLP method was accomplished with a minimum set of four restriction endonucleases ( Hae III, Dde I, Nco I, and Ava I). To compensate for potential genetic drift within the recognition sites of Hae III, Dde I, or Nco I in atypical clinical samples, the RFLP patterns generated with Hpa II and Sty I as replacements were analyzed. The specificity of the method was also successfully assessed by RFLP analysis of 55 reference nonpoliovirus enterovirus controls. The concerted implementation of these conditional protocols for diagnostic inter- and intratypic genotyping of polioviruses was evaluated with 21 clinical samples with absolute success.
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Non-concordance has often been reported as a major contributor to the failure of occlusion therapy for amblyopia. In other fields of medicine the extent of a patient's understanding in areas of the disease and treatment has been shown to have both a direct and indirect effect on subsequent concordance. The aims of this study were to determine the extent of parental non-concordance, to assess their level of understanding in key areas of amblyopia, occlusion therapy, critical period and prognosis, and to discover the parent's own reasons for failing to concord.Parents of children aged 2-7 years receiving a minimum of 1 hour of occlusion for unilateral amblyopia were recruited. Parental concordance was monitored using a diary and their understanding and reasons for non-concordance were assessed by a questionnaire. Concordance was analysed by calculating a concordance index, determining the proportion of non-concordance, and also by classifying the non-concordance on the basis of whether the behaviour was intentional or unintentional and whether the parents were adequately or inadequately informed.Parental non-concordance was defined as failing to occlude less than 80% of the total prescribed time. The median concordance index was 0.75 and the proportion of non-concordant parents was 0.54 (95% CI 0.41 to 0.67) (n = 57). Parental knowledge was poor in areas of the critical period with 23% of parents unaware of an age limit to the treatment. Reasons for non-concordance given by 68% of parents demonstrated poor knowledge.A substantial proportion of the non-concordant parents had poor understanding in areas such as the critical period and errors also occurred in implementing the treatment regimen. Increased parental awareness of the rationale and urgency of the treatment, with reinforcement of details of the regimen, would help to reduce non-concordance with occlusion therapy.
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