COVID-19 Pandemic Planning: Simulation Models to Predict Biochemistry Test Capacity for Patient Surges.

BACKGROUND: Patient surges beyond hospital capacity during the initial phase of the COVID-19 pandemic emphasized a need for clinical laboratories to prepare test processes to support future patient care. The objective of this study was to determine if current instrumentation in local hospital laboratories can accommodate the anticipated workload from COVID-19 infected patients in hospitals and a proposed field hospital in addition to testing for non-infected patients. METHODS: Simulation models predicted instrument throughput and turn-around-time for chemistry, ion-selective-electrode, and immunoassay tests using vendor-developed software with different workload scenarios. The expanded workload included tests from anticipated COVID patients in 2 local hospitals and a proposed field hospital with a COVID-specific test menu in addition to the pre-pandemic workload. RESULTS: Instrumentation throughput and turn-around time at each site was predicted. With additional COVID-patient beds in each hospital, the maximum throughput was approached with no impact on turnaround time. Addition of the field hospital workload led to significantly increased test turnaround times at each site. CONCLUSIONS: Simulation models depicted the analytic capacity and turn-around times for laboratory tests at each site and identified the laboratory best suited for field hospital laboratory support during the pandemic.

Current status of development of methylation biomarkers for in vitro diagnostic IVD applications.

A significant volume of research clearly shows that disease-related methylation changes can be used as biomarkers at all stages of clinical disease management, including risk assessment and predisposition screening through early diagnostics to personalization of patient care and monitoring of the relapse and chronic disease. Thus disease-related methylation changes are an attractive source of the biomarkers that can have significant impact on precision medicine. However, the translation of the research findings in methylation biomarkers field to clinical practice is at the very least not satisfactory. That is mainly because the evidence generated in research studies indicating the utility of the disease-related methylation change to predict clinical outcome is in majority of the cases not sufficient to postulate the diagnostic use of the biomarker. The research studies need to be followed by well-designed and systematic investigations of clinical utility of the biomarker that produce data of sufficient quality to meet regulatory approval for the test to be used to make clinically valid decision. In this review, we describe methylation-based IVD tests currently approved for IVD use or at the advanced stages of the development for the diagnostic use. For each of those tests, we analyze the technologies that the test utilizes for methylation detection as well as describe the types of the clinical studies that were performed to show clinical validity of the test and warrant regulatory approval. The examples reviewed here should help with planning of clinical investigations and delivery of the clinical evidence required for the regulatory approval of potential methylation biomarker based IVD tests.

Home testing for male factor infertility: a review of current options.

Male factor infertility contributes to about 50% of the incidence of infertility in couples. Semen analysis is key to the diagnosis of the reproductive potential of a male subject. In current practice, men must attend a clinic or other hospital facility to have their semen analyzed. However, many men are not comfortable with this process, which they often find embarrassing and expensive. To solve these problems, many devices for home analysis of semen samples have been developed and commercialized. This review examines the literature pertaining to the currently available home semen test devices and describes their limitations and future directions.

Convenient Formulation of 68Ga-BPAMD Patient Dose Using Lyophilized BPAMD Kit and 68Ga Sourced from Different Commercial Generators for Imaging of Skeletal Metastases.

PURPOSE: 68Ga-BPAMD has recently emerged as one of the preferred radiopharmaceuticals for imaging of bone lesions due to its ability to produce high-resolution images and uncomplicated availability of 68Ga, a positron emission tomography (PET) radionuclide, from commercial 68Ge/68Ga generators. The primary objective of this work is to develop freeze-dried BPAMD kit, for the easy and convenient formulation of 68Ga-BPAMD patient dose at the hospital radiopharmacy. In addition, the kit should be compatible with 68Ga, eluted using HCl of various molarities from the 68Ge/68Ga generators sourced from different suppliers. PROCEDURES: Freeze-dried BPAMD kit, comprising 50 µg of BPAMD and 150 mg of HEPES, was prepared and evaluated using 68Ga eluted from three different 68Ge/68Ga generators. Radiochemical purity (RCP) of 68Ga-BPAMD was determined by both thin-layer chromatography and high-performance liquid chromatography studies. The maximum volume of 68Ga, which can be added in the kit, was determined. The biological behavior of 68Ga-BPAMD, prepared using the freeze-dried kit, was evaluated by both in vitro and in vivo studies. Clinical studies were also performed in limited number of patients suffering from metastatic bone cancer. RESULTS: 68Ga-BPAMD could be prepared with >95% RCP using the freeze-dried BPAMD kit and 68Ga eluted from 68Ge/68Ga generators obtained from three different suppliers. 68Ga-BPAMD, prepared using the freeze-dried kit, exhibited adequate serum stability and ∼91% binding with the hydroxyapatite particles. Biodistribution studies in normal Wistar rats exhibited selective uptake of the agent in skeleton and fast clearance of the nonaccumulated activity through urinary route. Clinical studies in cancer patients showed excellent accumulation of the agent in bone lesions. CONCLUSION: The preliminary studies exhibited the potential of the developed BPAMD kit toward its utilization for the PET scanning of skeletal metastases.

Time taken to link newly identified HIV positive clients to care following a home-base index case HIV testing: Experience from two provinces in Zimbabwe.

BACKGROUND: Homebased index case HIV testing (HHTC) has shown higher uptake and good yield than traditional HIV testing methods. World Health Organization has called for increased operational research to evaluate HIV care processes particularly linkage to care. In this paper, we present project results of the time taken to link newly identified PLHIV to care after HHTC in the Manicaland and Midlands provinces of Zimbabwe. METHODS: We retrospectively reviewed community-facility referral data from the Zimbabwe HIV Care and Treatment project for newly diagnosed PLHIV for the period March-September 2016. A referral slip was given to a client after receiving a positive HIV results and was presented and filed upon reaching a health facility. In July 2016, the project started working with trained expert clients to assist with linkage to care. Data was entered in a spreadsheet and then imported for descriptive statistical analysis with EpiInfoTM Version 7.2.0.1. Odd ratios were used to identify factors associated with linkage to care within seven days. RESULTS: Out of 1004 newly identified PLHIV between March and September 2016, 650 (64.7%) were linked to care. The median time taken to be linked to care was four days (Interquartile range 19 days). Overall, 63.1% (410) of PLHIV were linked to care within seven days of diagnosis and 85% within 30 days. PLHIV were more likely to be linked to care within seven days of diagnosis between July and September 2016 (OR = 4.1; p< 0.001), a period when ZHCT started working with expert clients to support linkage to care. CONCLUSION: HHTC resulted in almost 63% of newly diagnosed PLHIV being linked into care within seven days, and 85% within 30 days. Linkage to care within seven days was significantly associated with the period of engaging expert clients in the project. We recommend community based HIV testing programs to work with expert clients to ensure timely linkages of new PLHIV.

Connectivity of diagnostic technologies: improving surveillance and accelerating tuberculosis elimination.

In regard to tuberculosis (TB) and other major global epidemics, the use of new diagnostic tests is increasing dramatically, including in resource-limited countries. Although there has never been as much digital information generated, this data source has not been exploited to its full potential. In this opinion paper, we discuss lessons learned from the global scale-up of these laboratory devices and the pathway to tapping the potential of laboratory-generated information in the field of TB by using connectivity. Responding to the demand for connectivity, innovative third-party players have proposed solutions that have been widely adopted by field users of the Xpert(®) MTB/RIF assay. The experience associated with the utilisation of these systems, which facilitate the monitoring of wide laboratory networks, stressed the need for a more global and comprehensive approach to diagnostic connectivity. In addition to facilitating the reporting of test results, the mobility of digital information allows the sharing of information generated in programme settings. When they become easily accessible, these data can be used to improve patient care, disease surveillance and drug discovery. They should therefore be considered as a public health good. We list several examples of concrete initiatives that should allow data sources to be combined to improve the understanding of the epidemic, support the operational response and, finally, accelerate TB elimination. With the many opportunities that the pooling of data associated with the TB epidemic can provide, pooling of this information at an international level has become an absolute priority.

[ON DEVELOPMENT OF TOOLS OF IMMUNE DIAGNOSTIC OF INFECTIOUS DISEASES: PROBLEMS OF DIAGNOSTIC IN VIVO AND IN VITRO].

The article considers a number of problematic issues concerning development of effective means of immune diagnostic of infectious diseases of bacterial and mycotic etiology related to approaches of choosing appropriate diagnostic targets.

The Present and Future of Low-Cost Diagnostics: A new class of portable, easy-to-use products is increasing access to health care around the world, yet challenges remain.

Imagine you?re in a rural health clinic in a Kenyan village. A child comes in with a fever. It could be any one of a number of life-threatening infectious diseases. There?s no refrigeration, no access to sophisticated laboratory equipment, and no highly trained personnel. How do you go about diagnosing and treating this child?

Home testing past, present and future: lessons learned and implications for HIV home tests.

The recent approval in the United States of the first rapid home test to diagnose HIV raises questions about its potential use and impact. We reviewed the existing literature on the unassisted use of home tests involving self-collection and testing of biological samples by untrained users-including existing HIV self-testing studies-to shed some light on what can be expected from the availability of the HIV home test. The studies reviewed showed that most participants could properly perform home tests, obtain accurate results, and interpret them-yielding high correlations with laboratory and health-professional performed tests. Users often had trouble performing blood-based tests. Participants generally understood the need to confirm positive test results. Materials accompanying HIV home tests should emphasize symptoms of acute infection and the need for additional testing when recent infection is suspected. Different home-test-based screening modalities, personalized HIV-counseling resources and HIV home test impact evaluation methods should be studied.

[Personal genomics: are we debating the right Issues?]. / Personalisierte Genomik: Führen wir die richtige Debatte?

The debate about personal genomics and their role in personalized medicine has been, to some extent, hijacked by the controversy about commercially available genomic tests sold directly to consumers. The clinical validity and utility of such tests are currently limited and most medical associations recommend that consumers refrain from testing. Conversely, DTC genomics proponents and particularly the DTC industry argue that there is personal utility in acquiring genomic information. While it is necessary to debate risks and benefits of DTC genomics, we should not lose sight of the increasingly important role that genomics will play in medical practice and public health. Therefore, and in anticipation of this shift we also need to focus on important implications from the use of genomics information such as genetic discrimination, privacy protection and equitable access to health care. Undoubtedly, personal genomics will challenge our social norms maybe more than our medicine. Sticking to the polarization of «to have or not to have DTC genomics¼ risks to takes us away from the critical issues we need to be debating.