Implementation and Performance of a Point-of-Care COVID-19 Test Program in 4,000 California Schools.

OBJECTIVE: To evaluate the feasibility and accuracy of an unprecedented COVID-19 antigen testing program in schools, which required a healthcare provider order, laboratory director, a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver, as well as training of school personnel. STUDY DESIGN: Descriptive report of a point-of-care, school-based antigen testing program in California from 8/1/2021 through 5/30/2022, in which participants grades K-12 self-swabbed and school personnel performed testing. Participants included 944,009 students, personnel, and community members from 4,022 California K-12 schools. Outcomes measured include sensitivity and specificity (with polymerase chain reaction [PCR] as comparator), of the Abbott BinaxNOW™ antigen test, number of tests performed, and active infections identified. RESULTS: Of 102,022 paired PCR/antigen tests, the overall sensitivity and specificity for the antigen test was 81.2% (95%CI:80.5%-81.8%) and 99.6% (95%CI:99.5%-99.6%), respectively using cycle threshold (Ct) values <30. During January through March 2022, the highest prevalence period, the positive predictive value (PPV) of antigen testing was 94.7% and the negative predictive value was 94.2%. Overall, 4,022 school sites were enrolled and 3,987,840 million antigen tests were performed on 944,009 individuals. A total of 162,927 positive antigen tests were reported in 135,163 individuals (14.3% of persons tested). CONCLUSIONS: Rapidly implementing a school-based testing program in thousands of schools is feasible. Self-swabbing and testing by school personnel can yield accurate results. On-site COVID-19 testing is no longer necessary in schools, but this model provides a framework for future infectious disease threats.

International Public Health Laboratory Twinning: An Innovative Approach to Strengthen the National Health Laboratory System in Uganda, 2014-2017.

International initiatives to strengthen national health laboratory systems in resource-poor countries are often hampered by unfamiliarity with the country's health laboratory environment and turnover of international partners during the initiative. This study provides an overview of, and lessons learned from, the use of a laboratory long-term partnership approach (ie, "twinning") to strengthen the national public health laboratory system in an international setting. We focused on the partnering of the Uganda Ministry of Health Central Public Health Laboratory (CPHL) with the New Mexico State Public Health Laboratory to help the CPHL become Uganda's national public health reference laboratory (Uganda National Health Laboratory Services [UNHLS] Institute) and leader of its nascent Uganda National Health Laboratory Network (UNHLN). Via twinning, CPHL leadership received training on laboratory leadership and management, quality systems, facility management, and the One Health environmental strategy (ie, that the health of persons is connected to the health of animals and the environment), and drafted a National Health Laboratory Policy, UNHLS Institute business plan, and strategic and operating plans for the UNHLS Institute and UNHLN. The CPHL is now responsible for the UNHLS Institute and coordinates the UNHLN. Lessons learned include (1) twinning establishes stable long-term collaborations and (2) success requires commitment to a formal statement of activities and objectives, as well as clear and regular communication among partners.

Using interorganizational partnerships to strengthen public health laboratory systems.

Due to the current economic environment, many local and state health departments are faced with budget reductions. Health department administrators and public health laboratory (PHL) directors need to assess strategies to ensure that their PHLs can provide the same level of service with decreased funds. Exploratory case studies of interorganizational partnerships among local PHLs in California were conducted to determine the impact on local PHL testing services and capacity. Our findings suggest that interorganizational forms of cooperation among local PHLs can help bolster laboratory capacity by capturing economies of scale, leveraging scarce resources, and ensuring access to affordable, timely, and quality laboratory testing services. Interorganizational partnerships will help local and state public health departments continue to maintain a strong and robust laboratory system that supports their role in communicable disease surveillance.

Core functions and capabilities of state public health laboratories: a report of the Association of Public Health Laboratories.

Emerging natural and man-made threats to the health of the nations population require development of a seamless laboratory network to address preventable health risks; this can be achieved only by defining the role of public health laboratories in public and private laboratory service delivery. Establishing defined core functions and capabilities for state public health laboratories will provide a basis for assessing and improving quality laboratory activities. Defining public health laboratory functions in support of public health programs is the beginning of the process of developing performance standards for laboratories, against which state public health laboratories, and eventually local public health and clinical laboratories, will establish and implement best laboratory practices. Public health is changing, and as apart of that change, public health laboratories must advocate for and implement improvements for public health testing and surveillance. These changes are outlined also in the Association of Public Health Laboratories consensus report (Association of Public Health Laboratories. Core functions and capabilities of state public health laboratories: a white paper for use in understanding the role and value of public health laboratories in protecting our nation's health. Washington, DC: Association of Public Health Laboratories, 2000).

An ELISA for Detection of Botulinal Toxin Types A, B, and E in Inoculated Food Samples.

An enzyme-linked immunosorbent assay (ELISA) was developed to screen for the presence of botulinal toxin types A, B, and E in inoculated food studies. A commercially available trivalent antitoxin (Connaught Laboratories, Ontario) was used as a capture antibody and biotinylated for use as a secondary antibody. An avidin-alkaline phosphatase conjugate coupled with an enzymebased amplification system resulted in a high degree of sensitivity. Detection levels of purified neurotoxins in gelatin phosphate buffer were 9 LD50 for type A and <1 intraperitoneal mouse LD50 for types B and E, respectively. Toxin produced by two-type F strains (proteolytic and nonproteolytic) was detected in a liquid laboratory medium. In a comparative study of over 490 samples of ground turkey meat inoculated with C. botulinum types E and nonproteolytic B, the ELISA gave no false negatives and 91 false positives. False positives were thought to be due to the presence of inactivated toxin or toxin levels insufficient to cause mouse death. Statistical analysis of these data showed an ELISA sensitivity of 100%, specificity of 70.6%, and an efficiency of 81.4% when compared to the mouse bioassay for detection of botulinal toxins types B and E. Coffee intermediates inoculated with proteolytic Clostridium botulinum types A and B caused nonspecific death in mice but were negative for presence of toxin by ELISA.