Comprehensive, comparative evaluation of 25 automated SARS-CoV-2 serology assays.

IMPORTANCE: We have previously highlighted the fact that hundreds of SARS-CoV-2 serology tests were released months after the onset of the COVID-19 pandemic. Of the hundreds of studies investigating the test kits' performance, few were comparative reports, using the same comprehensive sample set across multiple tests. Recently, we reported a comparative assessment of 35 rapid diagnostic tests (RDTs) or microtiter plate enzyme immunoassays (EIA) for use in low- and middle-income countries, using a large sample set from individuals with a history of COVID-19. Only a few tests meet WHO Target Product Profile performance requirements. This study reports on the performance of a further 25 automated SARS-CoV-2 immunoassays using the same panel of samples. The results highlight the better analytical and clinical performance of automated serology test kits compared with RDTs, and the importance of independent comparative assessments to inform the use and procurement of these tests for both diagnostic and epidemiological investigations.

Comprehensive, Comparative Evaluation of 35 Manual SARS-CoV-2 Serological Assays.

The onset of the coronavirus disease 2019 (COVID-19) pandemic resulted in hundreds of in vitro diagnostic devices (IVDs) coming to market, facilitated by regulatory authorities allowing "emergency use" without a comprehensive evaluation of performance. The World Health Organization (WHO) released target product profiles (TPPs) specifying acceptable performance characteristics for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) assay devices. We evaluated 26 rapid diagnostic tests and 9 enzyme immunoassays (EIAs) for anti-SARS-CoV-2, suitable for use in low- and middle-income countries (LMICs), against these TPPs and other performance characteristics. The sensitivity and specificity ranged from 60.1 to 100% and 56.0 to 100%, respectively. Five of 35 test kits reported no false reactivity for 55 samples with potentially cross-reacting substances. Six test kits reported no false reactivity for 35 samples containing interfering substances, and only one test reported no false reactivity with samples positive for other coronaviruses (not SARS-CoV-2). This study demonstrates that a comprehensive evaluation of the performance of test kits against defined specifications is essential for the selection of test kits, especially in a pandemic setting. IMPORTANCE The markets have been flooded with hundreds of SARS-CoV-2 serology tests, and although there are many published reports on their performance, comparative reports are far fewer and tend to be limited to only a few tests. In this report, we comparatively assessed 35 rapid diagnostic tests or microtiter plate enzyme immunoassays (EIAs) using a large set of samples from individuals with a history of mild to moderate COVID-19, commensurate with the target population for serosurveillance, which included serum samples from individuals previously infected, at undetermined time periods, with other seasonal human coronaviruses, Middle East respiratory syndrome coronavirus (MERS-CoV), and SARS-CoV-1. The significant heterogeneity in their performances, with only a few tests meeting WHO target product profile performance requirements, highlights the importance of independent comparative assessments to inform the use and procurement of these tests for both diagnostics and epidemiological investigations.

Established Populations of Rickettsia parkeri-Infected Amblyomma maculatum Ticks in New York City, New York, USA.

Objectives: We sought to determine the habitat associations and pathogen status of Amblyomma maculatum ticks in New York City (NYC), New York, USA, a newly expanded portion of their range. Methods: We collected 88 ticks from two NYC parks on Staten Island, one of the five boroughs of NYC, and compared our findings with similar habitat in Brooklyn, New York during the same time period (April 30-September 1). We tested 76 for pathogens. Results: We found adult and immature ticks in native and invasive grasses at Freshkills and Brookfield parks on Staten Island. No A. maculatum ticks were found in Brooklyn. 52.6% of ticks tested were infected with Rickettsia parkeri-the etiological agent of R. parkeri rickettsiosis. Conclusions: This high rate of R. parkeri in a dense urban center is of concern to the medical community, who should be aware of this species' presence and the symptoms of R. parkeri rickettsiosis.

Report on a workshop on the laboratory diagnosis of measles.

The Western Pacific Region of the World Health Organization (WHO) has declared a goal of regional measles elimination with a target date of 2012. To facilitate this goal, and in order to increase the familiarity of staff from some Western Pacific national laboratories with the technique of enzyme immunoassay (EIA) for the detection of anti-measles IgM, a WHO sponsored workshop was held at the Victorian Infectious Diseases Reference Laboratory (VIDRL) in May 2005. The workshop included participants from national laboratories in Cambodia and Lao People's Democratic Republic, and from five Pacific Island countries, Fiji, French Polynesia, Guam, New Caledonia and Papua New Guinea. An observer from Guam also participated. In addition to increasing the workshop participants' familiarity with the Dade Behring Enzygnost Anti-Measles Virus/IgM assay by hands-on involvement, the participants learnt to use dried venous blood spots for measles diagnosis. All participants successfully completed the practical component of the workshop. The workshop also included informal seminars on troubleshooting problems in EIA, good laboratory practice, data management in the laboratory and transporting infectious and diagnostic material. The EIA measles IgM calculation worksheets and the seminar on good laboratory practice were considered to be particularly useful by the majority of participants. The workshop was considered a success in terms of equipping participants with the knowledge and capacity to perform accurate measles IgM testing for both serum and dried venous blood spots. It also provided an introduction to proficiency testing.