Aotearoa New Zealand Deaf women's perspectives on breast and cervical cancer screening.

Aims: Since the introduction of both cervical and breast screening programmes in Aotearoa New Zealand, mortality rates have dropped. Both screening programmes track women's engagement, but neither capture the level of engagement of Deaf women who are New Zealand Sign Language users or their experiences in these screening programmes. Our paper addresses this knowledge deficit and provides insights that will benefit health practitioners when providing screening services to Deaf women.

Results from an IFCC global survey on laboratory practices for the analysis of circulating tumor DNA.

Background: The clinical validity of ctDNA analysis as a diagnostic, prognostic and predictive biomarker has been demonstrated in many studies. The rapid spread of tests for the analysis of ctDNA raises questions regarding their standardization and quality assurance. The aim of this study was to provide a global overview of the test methods, laboratory procedures and quality assessment practices using ctDNA diagnostics.

Molecular diagnostics of SARS-CoV-2: Findings of an international survey.

Background: In the current COVID-19 pandemic, early and rapid diagnosis of potentially infected and contagious individuals enables containment of the disease through quarantine and contact tracing. The rapid global expansion of these diagnostic testing services raises questions concerning the current state of the art with regard to standardization of testing and quality assessment practices. The aim of this study was to provide a global overview of the test methods, laboratory procedures and quality assessment practices used for SARS-CoV-2 diagnostics.

Current and future challenges in quality assurance in molecular diagnostics.

The development and performance of molecular genetic assays has required increasingly complex quality assurance in recent years and continues to pose new challenges. Quality management officers, as well as academic and technical personnel are confronted with new molecular genetic parameters, methods, changing regulatory environments, questions regarding appropriate validation, and quality control for these innovative assays that are increasingly applying quantification and/or multiplex formats. Yet, quality assurance and quality control guidelines are still not widely available or in some circumstances have become outdated.

External quality assessment (EQA) and alternative assessment procedures (AAPs) in molecular diagnostics: findings of an international survey.

Objectives: Quality management for clinical laboratories requires the establishment of internal procedures including standard operating procedures (SOPs), internal quality control (QC), validation of test results and quality assessment. External quality assessment (EQA) and alternativeassessment procedures (AAPs) are part of the quality hierarchy required for diagnostic testing. The International Organization for Standardization (ISO) document with requirements for conformance ISO 15189 and the Clinical and Laboratory Standards Institute document (CLSI) QMS24 require participation in EQA schemes and AAPs where applicable.

Toward harmonization of clinical molecular diagnostic reports: findings of an international survey.

Background: The International Organization for Standardization (ISO) 15189 standard provides recommendations for the postexamination reporting phase to enhance quality in clinical laboratories. The purpose of this study was to encourage a broad discussion on current reporting practices for molecular diagnostic tests by conducting a global survey of such practices.

Methods: The International Federation of Clinical Chemistry and Laboratory Medicine's Committee for Molecular Diagnostics (IFCC C-MD) surveyed laboratories on selected ISO 15189 recommendations and topics.

"It's just so bloody hard": recommendations for improving health interventions and maternity support services for disabled women.

Purpose: Little is known about the barriers and facilitators to pregnancy, birth and motherhood for disabled women within the New Zealand context. Our study explored this deficit with the aim of improving health care interventions and support for disabled mothers.

Methods: This paper reports on the third phase of a mixed-methods study.

Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach.

Background: Multiple organizations produce guidance documents that provide opportunities to harmonize quality practices for diagnostic testing. The International Organization for Standardization ISO 15189 standard addresses requirements for quality in management and technical aspects of the clinical laboratory. One technical aspect addresses the complexities of the pre-examination phase prior to diagnostic testing.

One percent tenofovir applied topically to humanized BLT mice and used according to the CAPRISA 004 experimental design demonstrates partial protection from vaginal HIV infection, validating the BLT model for evaluation of new microbicide candidates.

Recent iPrEx clinical trial results provided evidence that systemic preexposure prophylaxis (PrEP) with emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) can partially prevent rectal HIV transmission in humans. Similarly, we have previously demonstrated that systemic administration of the same FTC-TDF combination efficiently prevented rectal transmission in humanized bone marrow/liver/thymus (BLT) mice. The CAPRISA 004 trial recently demonstrated that topical application of the tenofovir could partially prevent vaginal HIV-1 transmission in humans.

Nucleic acid reference materials (NARMs): definitions and issues.

Molecular diagnostics is one of the most rapidly growing areas of laboratory medicine. This rapid growth of clinical molecular tests has outpaced the availability and development of reference methods and reference materials. Such methods and materials are important for the development, validation, and interpretation of diagnostic methods and tests.

Antiplatelet agents and risk factors for bleeding postcarotid endarterectomy.

Background: Antiplatelet therapy has been implicated as a risk factor for wound hematoma formation after carotid endarterectomy (CEA). Given the increasing use of alternative antiplatelet drugs acting through differing inhibitory pathways, we audited the incidence of re-operation for bleeding post-CEA.

Methods: Data were prospectively recorded on all patients undergoing CEA in Leicester, United Kingdom between November 1997 and October 2001.

Systemic administration of antiretrovirals prior to exposure prevents rectal and intravenous HIV-1 transmission in humanized BLT mice.

Successful antiretroviral pre-exposure prophylaxis (PrEP) for mucosal and intravenous HIV-1 transmission could reduce new infections among targeted high-risk populations including discordant couples, injection drug users, high-risk women and men who have sex with men. Targeted antiretroviral PrEP could be particularly effective at slowing the spread of HIV-1 if a single antiretroviral combination were found to be broadly protective across multiple routes of transmission. Therefore, we designed our in vivo preclinical study to systematically investigate whether rectal and intravenous HIV-1 transmission can be blocked by antiretrovirals administered systemically prior to HIV-1 exposure.

Monitoring of BK viral load in renal allograft recipients by real-time PCR assays.

BK virus (BKV) is a nonenveloped, double-stranded DNA virus of the polyomavirus family that primarily affects immunocompromised people. BKV may cause nephropathy in renal transplant recipients receiving immunosuppressive therapy, resulting in renal dysfunction and, possibly, graft loss. Monitoring of BK viral load in urine and blood has been used as a surrogate marker of BKV nephropathy (BKVN).

Development and characterization of reference materials for MTHFR, SERPINA1, RET, BRCA1, and BRCA2 genetic testing.

Well-characterized reference materials (RMs) are integral in maintaining clinical laboratory quality assurance for genetic testing. These RMs can be used for quality control, monitoring of test performance, test validation, and proficiency testing of DNA-based genetic tests. To address the need for such materials, the Centers for Disease Control and Prevention established the Genetic Testing Reference Material Coordination Program (GeT-RM), which works with the genetics community to improve public availability of characterized RMs for genetic testing.

The antithrombotic effect of dextran-40 in man is due to enhanced fibrinolysis in vivo.

Background: Dextran-40 is effective in reducing postoperative Doppler-detectable embolization in patients undergoing carotid endarterectomy (CEA). Dextrans are thought to have antithrombotic and antiplatelet effects. The mode of action is unclear.

Unusual case of Epstein-Barr virus DNA tissue positive: blood negative in a patient with post-transplant lymphoproliferative disorder.

Detection of PTLD uses PCR to detect circulating EBV DNA in the blood or in situ hybridization to identify EBV DNA in tissue biopsies. EBV DNA was detected in the tissue section using both real-time PCR and in situ hybridization. We report an unusual presentation of PTLD with no detectable EBV DNA in the blood using EBER-1 and EBNA-1 PCR assays.

Field-induced strain behavior for potassium sodium bismuth titanate ceramics.

Data are reported for the dielectric, piezoelectric, electrostrictive, and ferroelectric properties of potassium-substituted sodium bismuth titanate, [(K(x)Na(1-x))(0.5)Bi(0.5)]TiO3.

Measurements along the growth direction of PMN-PT crystals: dielectric, piezoelectric, and elastic properties.

Property measurements are reported for Pb(Mg1/3Nb2/3)03-PbTiO3 (PMN-PT) single crystals grown along (001) by a seeded-melt method. Chemical segregation occurs during crystal growth, leading to property changes along the growth direction. Variations in dielectric, piezoelectric, and elastic properties were evaluated for specimens selected from the crystals.

Therapeutic benefit of low-dose clopidogrel in patients undergoing carotid surgery is linked to variability in the platelet adenosine diphosphate response and patients' weight.

Background And Purpose: We have previously shown that a single 75-mg tablet of clopidogrel, taken before carotid endarterectomy, significantly reduces postoperative embolization, a marker of thromboembolic stroke. This study explores the antiplatelet effect of this submaximal dose.

Methods: Fifty-six patients on long-term aspirin (150 mg) were randomized to 75 mg clopidogrel or placebo before carotid endarterectomy.

Cerebral protection during open retrograde angioplasty/stenting of common carotid and innominate artery stenoses.

Background: This was a retrospective study of the effectiveness of open, retrograde angioplasty/stenting of supra-aortic arterial stenoses combined with transcranial Doppler-directed dextran therapy in preventing perioperative embolization.

Methods: Eight patients underwent angioplasty/stenting of the proximal common carotid (synchronous carotid endarterectomy (CEA) in six), while four underwent angioplasty/stenting of the innominate artery (synchronous CEA in one). Open exposure of the carotid bifurcation enabled temporary carotid clamping to protect the brain from procedural embolization.

Developing a sustainable process to provide quality control materials for genetic testing.

Purpose: To provide a summary of the outcomes of two working conferences organized by the Centers for Disease Control and Prevention (CDC), to develop recommendations for practical, sustainable mechanisms to make quality control (QC) materials available to the genetic testing community.

Methods: Participants were selected to include experts in genetic testing and molecular diagnostics from professional organizations, government agencies, industry, laboratories, academic institutions, cell repositories, and proficiency testing (PT)/external Quality Assessment (EQA) programs. Current efforts to develop QC materials for genetic tests were reviewed; key issues and areas of need were identified; and workgroups were formed to address each area of need and to formulate recommendations and next steps.

Molecular diagnosis of infectious diseases in dermatology.

Unlabelled: The molecular diagnosis of infectious disease has been growing considerably over the past decade. Nucleic acid amplification techniques, such as polymerase chain reaction, ligase chain reaction, transcription-mediated amplification, and nucleic acid sequence-based amplification, provide highly accurate diagnosis of numerous bacterial, viral, fungal, and parasitic infections involved in a variety of dermatologic diseases. In addition, signal amplification with hybrid capture, branched-DNA assays, and in situ hybridization have been used to detect numerous viral pathogens with high degrees of sensitivity and specificity.