An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada.

BACKGROUND: Self testing for HIV is a targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed, especially in priority populations. The objectives of this study were to (1) evaluate the INSTI HIV self-test performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV self-test device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for regulatory approval purposes. METHODS: The study used a cross-sectional design and recruited consenting adults who were representative of intended users of HIV self-testing from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV self-test were compared with results of the Abbott Architect HIV Ag/Ab Combo test. Usability outcomes for critical (e.g., lancing finger, blood droplet into bottle, shaking bottle four times) and noncritical self-test procedure steps were also determined. RESULTS: Overall, 77% (n = 522) of participants were between 18 and 45 years of age, 61% (n = 410) were male, 71% (n = 480) had some college or more education, and 45% (n = 307) were employed; identity for race and ethnicity: Caucasian (44%; n = 296), African, Caribbean or Black (17%; n = 113), Indigenous [First Nations, Métis or Inuit] (14%; n = 95), Asian (16%; n = 106), Latin American (7%; n = 46). Primary performance analysis on 678 completed HIV self-tests revealed a positive percent agreement of 100% (5/5, 95% CI: 43.6-97.0%) and a negative percent agreement of 99.5% (614/617, 95% CI: 98.6-99.8%) with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5% (n = 633). For the 708 participants who took part in the usability study, the average success rate for steps determined to be "critical" for successful completion of the test was 92.4%. 97% (n = 670) of participants found the instructions easy to follow, and 95% (n = 655) of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative, and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive, n = 366) to 99.3% (for negative, n = 401). CONCLUSIONS: The addition of a regulatory-approved self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. Having a blood-based HIV self-test approved in Canada can offer an accurate, acceptable, and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions.

A Novel MEMS Capacitive Microphone with Semiconstrained Diaphragm Supported with Center and Peripheral Backplate Protrusions.

Audio applications such as mobile phones, hearing aids, true wireless stereo earphones, and Internet of Things devices demand small size, high performance, and reduced cost. Microelectromechanical system (MEMS) capacitive microphones fulfill these requirements with improved reliability and specifications related to sensitivity, signal-to-noise ratio (SNR), distortion, and dynamic range when compared to their electret condenser microphone counterparts. We present the design and modeling of a semiconstrained polysilicon diaphragm with flexible springs that are simply supported under bias voltage with a center and eight peripheral protrusions extending from the backplate. The flexible springs attached to the diaphragm reduce the residual film stress effect more effectively compared to constrained diaphragms. The center and peripheral protrusions from the backplate further increase the effective area, linearity, and sensitivity of the diaphragm when the diaphragm engages with these protrusions under an applied bias voltage. Finite element modeling approaches have been implemented to estimate deflection, compliance, and resonance. We report an 85% increase in the effective area of the diaphragm in this configuration with respect to a constrained diaphragm and a 48% increase with respect to a simply supported diaphragm without the center protrusion. Under the applied bias, the effective area further increases by an additional 15% as compared to the unbiased diaphragm effective area. A lumped element model has been also developed to predict the mechanical and electrical behavior of the microphone. With an applied bias, the microphone has a sensitivity of -38 dB (ref. 1 V/Pa at 1 kHz) and an SNR of 67 dBA measured in a 3.25 mm × 1.9 mm × 0.9 mm package including an analog ASIC.

Antimicrobial susceptibility profile of selected bacteraemic pathogens from private institutions in South Africa.

OBJECTIVES: The National Antimicrobial Surveillance Forum is a continuous surveillance organisation comprising all academic/public and private sector laboratories in South Africa. METHODS: The antibiotic susceptibility of blood culture isolates of Escherichia coli, Klebsiella pneumoniae, Enterobacter species, Pseudomonas aeruginosa, Acinetobacter baumannii and Staphylococcus aureus from patients in private hospitals in five major centres were investigated. Antimicrobial susceptibility tests were performed by 12 participating laboratories according to the Clinical and Laboratory Standards Institute (CLSI) guidelines. Extended-spectrum b-lactamase (ESBL) production was determined in selected species of Enterobacteriaceae irrespective of source. RESULTS: The overall prevalence of ampicillin resistance in blood culture isolates of E. coli (N = 471) was 84%, and 20% were resistant to the fluoroquinolones. Considerable geographical differences were noted between the centres with regard to the K. pneumoniae (N = 636) resistance rates for ceftriaxone and/or cefotaxime (39 - 87%). The most active agents in the Enterobacter spp. (N = 244) were imipenem/meropenem, ertapenem, ciprofloxacin, levofloxacin and cefepime, with 100%, 94%, 88%, 87% and 80% susceptibility, respectively. Carbapenem resistance in P. aeruginosa (N = 382) varied between 42% and 45%, and in the case of A. baumannii (N = 190) resistance varied between 32% and 33% for meropenem and imipenem respectively. The nationwide incidence of oxacillin resistance in S. aureus (N = 629) was 36%. Overall, the prevalence of ESBL production among all isolates of K. pneumoniae was 26% (N = 7 514), while in Enterobacter spp. it was 12% (N = 4 031) and in E. coli 5% (N = 28 412). CONCLUSIONS: The data highlight the widespread problem of antibiotic resistance among important bacteraemic pathogens in private institutions in South Africa. Continued surveillance is vital to guide appropriate empirical therapy for invasive infections.