Evaluation of the rapid BioStar optical immunoassay for detection of Chlamydia trachomatis in adolescent women.

We evaluated the performance of the BioStar Chlamydia OIA (optical immunoassay) in adolescent females (n = 261) from an inner city population. With a reference standard of two different nucleic acid amplification tests, the sensitivity and specificity of the BioStar Chlamydia OIA were 59.4 and 98.4%, respectively. Due to its relatively low sensitivity, the BioStar Chlamydia OIA should only be used in conjunction with more sensitive laboratory tests unless laboratory tests are unavailable or timely return for treatment is unlikely.

Building Biosafety Capacity in Our Nation's Laboratories.

The 2014 Ebola outbreak revealed biosafety vulnerabilities across the United States. We distributed $24.1 million to health departments to support public health laboratories (PHLs) and sentinel clinical laboratory partners to improve biosafety practices. We used 9 indicators to evaluate PHLs and associated clinical laboratories from March 2015 through April 2018 using descriptive statistics. On average, over 6 reporting periods, 59 awardee PHLs and 4,040 clinical laboratories responded. By April 2018, 92% (57 of 62) of PHLs had conducted at least 1 risk assessment for work with Ebola and another highly infectious disease. The number of PHLs having a policy for risk assessments increased from 32 of 61 (52%) to 49 of 54 (91%). The percentage of awardees meeting the target (80%) for associated clinical laboratories with staff certifications to package/ship rose from 32% (19 of 60) to 46% (25 of 54). The percentage of awardees meeting the target (70%) for associated clinical laboratories with risk assessment policies increased from 18% (8 of 44) to 28% (15 of 54). Awardees reported improvement among Ebola treatment centers/Ebola assessment hospitals with policies to perform risk assessments from 48% (20 of 42) to 67% (34 of 51). Public health laboratories and their clinical partners made progress on their abilities to address biosafety concerns and implement consistent biosafety practices, improving their ability to work safely with biological threats. More attention is needed to address gaps in the clinical community. Support for biosafety activities is critical to continuing to achieve progress.