Association Between Social Vulnerability and SARS-CoV-2 Seroprevalence in Specimens Collected From Commercial Laboratories, United States, September 2021-February 2022.

OBJECTIVE: We conducted a national US study of SARS-CoV-2 seroprevalence by Social Vulnerability Index (SVI) that included pediatric data and compared the Delta and Omicron periods during the COVID-19 pandemic. The objective of the current study was to assess the association between SVI and seroprevalence of infection-induced SARS-CoV-2 antibodies by period (Delta vs Omicron) and age group. METHODS: We used results of infection-induced SARS-CoV-2 antibody assays of clinical sera specimens (N = 406 469) from 50 US states from September 2021 through February 2022 to estimate seroprevalence overall and by county SVI tercile. Bivariate analyses and multilevel logistic regression models assessed the association of seropositivity with SVI and its themes by age group (0-17, ≥18 y) and period (Delta: September-November 2021; Omicron: December 2021-February 2022). RESULTS: Aggregate infection-induced SARS-CoV-2 antibody seroprevalence increased at all 3 SVI levels; it ranged from 25.8% to 33.5% in September 2021 and from 53.1% to 63.5% in February 2022. Of the 4 SVI themes, socioeconomic status had the strongest association with seroprevalence. During the Delta period, we found significantly more infections per reported case among people living in a county with high SVI (odds ratio [OR] = 2.76; 95% CI, 2.31-3.21) than in a county with low SVI (OR = 1.65; 95% CI, 1.33-1.97); we found no significant difference during the Omicron period. Otherwise, findings were consistent across subanalyses by age group and period. CONCLUSIONS: Among both children and adults, and during both the Delta and Omicron periods, counties with high SVI had significantly higher SARS-CoV-2 antibody seroprevalence than counties with low SVI did. These disparities reinforce SVI's value in identifying communities that need tailored prevention efforts during public health emergencies and resources to recover from their effects.

What if we just give everything away?

A group leader decided that his lab would share the fluorescent dyes they create, for free and without authorship requirements. Nearly 12,000 aliquots later, he reveals what has happened since.

Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like.

The coronavirus disease 2019 (COVID-19) response necessitated innovations and a series of regulatory deviations that also affected laboratory-developed tests (LDTs). To examine real-world consequences and specify regulatory paradigm shifts, legislative proposals were aligned on a common timeline with Emergency Use Authorization (EUA) of LDTs and the US Food and Drug Administration (FDA)-orchestrated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) labeling update study. The initial EUA adoption by LDT developers shows that the FDA can have oversight over LDTs. We used efficiency-corrected microcosting of our EUA PCR assay to estimate the national cost of the labeling update study to $0.3 to $1.4 million US dollars. Labeling update study performance data showed lower average detection limits in commercial in vitro diagnostic (IVD) assays versus LDTs (32,000 ± 75,000 versus 71,000 ± 147,000 nucleic acid amplification tests/mL; P = 0.04); however, comparison also shows that FDA review of IVD assays and LDTs did not prevent differences between initial and labeling update performance (IVD assay, P < 0.0001; LDT, P = 0.003). The regulatory shifts re-emphasized that both commercial tests and LDTs rely heavily on laboratory competence and procedures; however, lack of performance data on authorized tests, when clinically implemented, precludes assessment of the benefit related to regulatory review. Temporary regulatory deviations during the pandemic and regulatory science tools (ie, reference material) have generated valuable real-world evidence to inform pending legislation regarding LDT regulation.

Acceptance of a Symptom-Based Approach for COVID-19 rtRT-PCR Testing to Conserve Resources in a Lower Middle-Income Setting.

SARS-CoV-2 initially emerged in Wuhan, China in late 2019. It has since been recognized as a pandemic and has led to great social and economic disruption globally. The Reverse Transcriptase Real-Time Polymerase Chain Reaction (rtRT-PCR) has become the primary method for COVID-19 testing worldwide. The method requires a specialized laboratory set up. Long-term persistence of SARS-CoV-2 RNA in nasopharyngeal secretion after full clinical recovery of the patient is regularly observed nowadays. This forces the patients to spend a longer period in isolation and test repeatedly to obtain evidence of viral clearance. Repeated COVID-19 testing in asymptomatic or mildly symptomatic cases often leads to extra workload for laboratories that are already struggling with a high specimen turnover. Here, we present 5 purposively selected cases with different patterns of clinical presentations in which nasopharyngeal shedding of SARS-CoV-2 RNA was observed in patients for a long time. From these case studies, we emphasized the adoption of a symptom-based approach for discontinuing transmission-based precautions over a test-based strategy to reduce the time spent by asymptomatic and mildly symptomatic COVID-19 patients in isolation. A symptom-based approach will also help reduce laboratory burden for COVID-19 testing as well as conserve valuable resources and supplies utilized for rtRT-PCR testing in an emerging lower-middle-income setting. Most importantly, it will also make room for critically ill COVID-19 patients to visit or avail COVID-19 testing at their convenience.

Laboratory Perspective on Racial Disparities in Sexually Transmitted Infections.

BACKGROUND: Rates of sexually transmitted infections (STI) have risen steadily in recent years, and racial and ethnic minorities have borne the disproportionate burden of STI increases in the United States. Historical inequities and social determinants of health are significant contributors to observed disparities and affect access to diagnostic testing for STI. CONTENT: Public health systems rely heavily on laboratory medicine professionals for diagnosis and reporting of STI. Therefore, it is imperative that clinicians and laboratory professionals be familiar with issues underlying disparities in STI incidence and barriers to reliable diagnostic testing. In this mini-review, we will summarize contributors to racial/ethnic disparity in STI, highlight current epidemiologic trends for gonorrhea, chlamydia, and syphilis, discuss policy issues that affect laboratory and public health funding, and identify specific analytic challenges for diagnostic laboratories. SUMMARY: Racial and ethnic disparities in STI in the US are striking and are due to complex interactions of myriad social determinants of health. Budgetary cuts for laboratory and public health services and competition for resources during the COVID-19 pandemic are major challenges. Laboratory professionals must be aware of these underlying issues and work to maximize efforts to ensure equitable access to diagnostic STI testing for all persons, particularly those most disproportionately burdened by STI.

American Society for Clinical Pathology's 2019 Wage Survey of Medical Laboratories in the United States.

OBJECTIVES: To inform the pathology and laboratory field of the most recent national wage data. Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. METHODS: The 2019 Wage Survey was conducted through collaboration of the American Society for Clinical Pathology (ASCP) Institute of Science, Technology, and Policy in Washington, DC, and the ASCP Board of Certification in Chicago, Illinois. RESULTS: Compared with 2017, results show an overall increase in salaries for most laboratory occupations surveyed except cytogenetic technologists, laboratory information systems personnel, and performance improvement or quality assurance personnel. Geographically, laboratory professionals from urban areas earned more than their rural counterparts. CONCLUSIONS: As retirement rates continue to increase, the field needs to intensify its efforts on recruiting the next generation of laboratory personnel. To do so, the report urged the field to highlight advocacy for better salaries for laboratory personnel at the local and national levels when developing recruitment and retention strategies.

Avaliação externa da qualidade da identificação entomológica de triatomíneos realizada na Rede de Laboratórios Públicos em Pernambuco, 2017 / Evaluación externa de la calidad en la identificación entomológica de triatominos realizada en la red de laboratorios públicos en Pernambuco, Brasil, 2017 / External quality assessment of entomological identification of triatomines carried out in the Pernambuco Public Health Laboratory network, Brazil, 2017

Objetivo: Avaliar a qualidade da identificação de triatomíneos na rede de laboratórios do estado de Pernambuco, Brasil. Métodos: Os nove laboratórios participantes receberam material de apoio com as chaves dicotômicas e um painel composto por sete insetos triatomíneos conhecidos no estado, para identificação da situação do espécime no recebimento (estrutura completa ou danificada), espécie e sexo. Resultados: Nove laboratórios de 12 aderiram ao estudo. A proporção de acerto para identificação do sexo foi de 56/63, e para espécie, 45/63, não apresentando relação direta com a ocorrência de danos nas estruturas morfológicas durante o transporte dos insetos. Para Panstrongylus megistus, houve acerto em todos os espécimes (9/9), enquanto para espécies do gênero Rhodnius a proporção foi menor (3/9). Conclusão: Apesar do bom desempenho na identificação entomológica, as fragilidades observadas poderão orientar ações para melhoria na rede de laboratórios e serão essenciais para os programas de controle vetorial da doença de Chagas.

Objetivo: Evaluar la calidad de la identificación de triatominos en la red de laboratorios del estado de Pernambuco, Brasil. Métodos: Los nueve laboratorios participantes recibieron material de apoyo con claves dicotómicas y un panel conformado por siete insectos triatominos conocidas en el estado, para identificar la situación del espécimen al recibirlo (estructura completa o dañada), especie y sexo. Resultados: La adherencia al laboratorio fue del 9/12. La proporción de aciertos para la identificación del sexo fue del 56/63, y para las especies 45/63, no mostraron relación directa con la ocurrencia de daños en las estructuras morfológicas durante el transporte de insectos. Solo Panstrongylus megistus logró el 9/9 de precisión, mientras que para las especies del género Rhodnius fue el más pequeño (3/9). Conclusión: A pesar del buen desempeño en identificación entomológica, la evaluación indicó debilidades que permitirán implementar acciones correctivas para mejorar la red de laboratorios, esenciales para los programas de control vectorial de la enfermedad de Chagas.

Objective: To assess the quality of triatomine identification in the laboratory network of the state of Pernambuco, Brazil. Methods: The participating laboratories received support material with dichotomous keys and a panel made up of seven triatomine insects known in the Pernambuco, in order to identify specimen status on receipt (intact or damaged structure), as well as species and sex. Results: Nine out of 12 laboratories took part of the study. The proportion of correct answers was 56/63 for sex identification, and 45/63, for species. The answers did not present a direct relationship with occurrence of damage to morphological structures during insect transportation. Panstrongylus megistus identification was correct for all specimens (9/9 laboratories), while correct identification of species of the Rhodnius genus was the lowest (3/9 laboratories). Conclusion: Despite the good performance in entomological identification, the weaknesses observed may guide improvements in the laboratory network and will be essential for Chagas disease vector control programs.

Survey on request form content and result reporting in therapeutic drug monitoring service among laboratories in Czechia and Slovakia.

INTRODUCTION: The aim of the study was to investigate current practice and policies of therapeutic drug monitoring (TDM) service requesting and result reporting in Czechia and Slovakia. MATERIALS AND METHODS: All 149 laboratories that measure plasma drug concentrations were given an online questionnaire during a regular external quality assessment TDM cycle. The questionnaire consisted of 17 questions. The optimal TDM practice was defined as the application of all elements (age, body weight, time of sampling, date of the first administration, time of the last dose administration, the dose, the dosing interval, the route of administration, information on reason of testing, and information on other co-administered drugs) needed for reporting a recommendation for further drug dosing (positive response to question number 16). RESULTS: The response rate was 69%, 103 out of 149 laboratories measuring drug concentrations. Only 12% (12 out of 103 laboratories) of the laboratories implemented all elements needed for optimal TDM practice and reported a recommendation. Both paper and electronic request forms were used by 77 out of 103 (75%) laboratories. A total of 69 out of 103 laboratories (67%) specified the type of sampling tube on their request form. Cystatin C was used for prediction of renal drug elimination by 24% (25 out of 103) of participants. CONCLUSIONS: Small number of laboratories implemented all elements needed for optimal TDM practice and report a recommendation on further dosing. Further efforts in education on optimal TDM practice as well as harmonization of service are desirable.

Performance of Eastern Mediterranean Region laboratories in the World Health Organization external quality assessment programme for arbovirus diagnostics.

BACKGROUND: Arboviruses such as dengue virus, yellow fever virus, Zika virus and chikungunya virus are major threats to human health globally, including countries in the Eastern Mediterranean Region (EMR). AIMS: This study aimed to assess laboratory proficiency in EMR countries for detection of dengue virus, yellow fever virus, Zika virus and chikungunya virus. METHODS: A global external quality assessment programme for arbovirus diagnostics was developed and run in 2016 and 2018. National-level public health laboratories were instructed to apply the polymerase chain reaction detection method on specimen panels containing dengue virus, yellow fever virus, Zika virus and chikungunya virus. RESULTS: Over both rounds of the programme, 100% of participating EMR laboratories correctly detected yellow fever virus and chikungunya virus, ≥ 84.6% detected dengue fever virus and ≥ 76.9% detected Zika virus. CONCLUSION: While participating EMR countries demonstrated good proficiency in detecting arboviruses, only half of them were enrolled in the global external quality assessment programme, providing an incomplete picture of regional capacity. Effort should be put into increasing participation in subsequent rounds.

Current state of the morphological assessment of urinary erythrocytes in The Netherlands: a nation-wide questionnaire.

Background The morphological assessment of urinary erythrocytes (uRBC) is a convenient screening tool for the differentiation of nephrological (dysmorphic) and urological (isomorphic) causes of hematuria. Considering the morphological heterogeneity, this analysis is often perceived as difficult. There is no clear (inter)national consensus and there is a lack of external quality assessment programs. To gain insight into the heterogeneity within and between laboratories, we scrutinized the current state of this analysis in Dutch medical laboratories. Methods The laboratories, affiliated with the Dutch Foundation for Quality Assessment in Medical Laboratories, were invited to participate in a web-based survey, consisting of two questionnaires. The first one provided information about the institution and laboratory organization, and the second explored the variability in the morphological analysis of uRBC on the basis of categorization of 160 uRBC images. Statistical analysis was premised on binomial significance testing and principal component analysis. Results Nearly one third of the Dutch medical laboratories (65/191) with 167 staff members participated in the survey. Most of these laboratories (83%) were an integral part of secondary care. The statistical analysis of the evaluations of the participants in comparison to the consensus (three experts from two different medical laboratories) suggested a great degree of heterogeneity in the agreement. Nearly half of the participants consciously disagreed with the consensus, whereas one fifth demonstrated a random relationship with it. Conclusions In Dutch medical laboratories, results from morphological analysis of uRBC are heterogeneous, which point out the necessity for standardization and harmonization.

Risk assessment in academic laboratories in the west of Iran: compare the CHRA and the RSLs methods.

In the laboratories staffs, there is potential for adverse health effects in exposure to chemicals. Therefore, risk assessment is one of the main issues to prevent these effects. The purpose of this study was to assess the health risk of laboratory staffs and compare the two methods, including 'Chemical Health Risk Assessment' (CHRA) and 'Regional Screening Levels' (RSLs), that developed by the Department of Occupational Safety and Health of Malaysia and the Environmental Protection Agency respectively. Using these two methods, the places with the highest risk were identified. Comparisons showed that RSLs is a precise method without personal judgment. The CHRA is a simple method for wider chemicals that categorize risk. But CHRA includes fewer parameters compared to RSLs, as well as personal judgment. The results of the present study showed that two methods did not compatible. According to the characteristics of these two methods, it is recommended to use them as a compliment each other to obtain accurate results.

An Overview of Tuberculosis-Designated Hospitals in China, 2009-2015: A Longitudinal Analysis of National Survey Data.

DESIGN: A national tuberculosis- (TB-) designated hospital survey was conducted in 2015 to identify significant changes since 2009 in implementation of TB-testing services within hospitals of various types and administrative levels in various regions in China. METHODS: In 2015, all TB-designated hospitals were required to complete questionnaires designed by the National Clinical Center for TB. Community hospitals also completed simplified questionnaires as part of the study. RESULTS: Overall, in 2015 there were 1685 TB-designated hospitals in China, consisting of 1335 (79.2%) county-level hospitals and 350 (20.8%) hospitals at the prefecture level and above. The percentage of counties with TB-designated hospitals in the western region (57.4%) was significantly lower than corresponding percentages for eastern and middle regions (70.3% and 96.5, respectively). Based on data recorded on hospital surveys in both 2009 and 2015, significant differences were noted between years in proportions of general hospitals with TB wards and of specialized infectious disease hospitals (P < 0.01). Of 1256 county-level laboratories conducting smear microscopy, only 979 (79%) performed external quality control evaluations of test results in 2015. For prefecture-level hospitals, 70% (234/334), 76% (155/203), and 67% (66/98) of hospitals obtained external quality control validations of smear microscopy, phenotypic DST, and molecular test results, respectively. CONCLUSIONS: Although China's health reform efforts have resulted in improved TB patient access to quality health care, more attention should be paid to balancing the distribution of medical facilities across different regions. In addition, laboratory capabilities and quality control systems should be strengthened to ensure delivery of high-quality laboratory services by TB-designated hospitals throughout China.

Assessment of laboratory capacity of public secondary health facilities in performing assay of selected epidemic-prone diseases in Oyo State, Nigeria.

This study assessed the capacity of public secondary facility-based laboratories in conducting diagnostic tests for selected epidemic-prone diseases in Oyo State, Nigeria. A descriptive cross-sectional study was conducted in 17 secondary facility-based laboratories in Oyo State. Capacity was assessed on a 100-point scale in which scores were rated low (≤49%), fair (50-79%) and good (≥80%). Diagnostic testing capacity for bacterial meningitis, cholera, and measles was "low" in all the laboratories. The reasons reported for laboratories not conducting diagnostic tests for the selected diseases included inadequate instruments, unavailable reagents, and clinicians' failure to request those diagnostic tests. Laboratory capacity to perform diagnostic tests for the selected diseases was low in Oyo State secondary hospitals. There is a need for the provision of modern instruments and reagents, as well as clinician laboratorian quality assurance programs, to improve diagnostic services relating to the selected diseases.

External Quality Assessment Program for Newborn Screening of Acylcarnitine in China, 2018.

BACKGROUND: The aim of this study was to analyze the 2018 external quality assessment (EQA) results of newborn screening by MS/MS of acylcarnitine by Chinese National Center for Clinical Laboratories and to determine the performance of clinical laboratories. METHODS: Five dried blood spots were distributed to participants every round. Satisfactory performance was defined as scores more than 80 of acceptable results within the evaluation criterion. The robust coefficient of variability (RCV) of each sample was calculated by measurement systems. The chi-square (2) test was used to compare the correct recognition rates. RESULTS: EQA results were collected from 150 laboratories for 15 different acylcarnitines between C0 - C18. The overall acceptable rates of the qualitative results were between 81.21% and 96.67%, and the proportion of acceptable quantitative results were between 78.38% and 93.24%. There were significant differences in the rates of acceptable quantitative results among different items and between the four methods. CONCLUSIONS: Most of the participant laboratories had satisfactory performance for the quantitative results in this EQA scheme. But for qualitative assessment, a laboratory should re-evaluate and validate their reference intervals on a regular basis to improve the consistency of clinical assessment.

The Relationship between Health Information Technology Laboratory Tracking Systems and Hospital Financial Performance and Quality.

The objective of this study is to explore the relationship between hospitals Health Information Technology (HIT), and financial and quality performance. The study merged the 2017 Centers for Medicare & Medicaid Services (CMS) Healthcare Cost Report Information System, American Hospital Association Annual Survey, and two CMS Hospital Compare datasets. A total of 3002 hospitals were analyzed using multivariate analysis. We found that hospitals with laboratory tracking systems reported better financial performance on five financial performance measures. Policymakers should consider developing policies that facilitate exploration and adoption of various hospital HIT capabilities that measurably improves hospital quality of care.

Analysis of influenza data generated by four epidemiological surveillance laboratories in Mexico, 2010-2016.

The disease caused by the influenza virus is a global public health problem due to its high rates of morbidity and mortality. Thus, analysis of the information generated by epidemiological surveillance systems has vital importance for health decision making. A retrospective analysis was performed using data generated by the four molecular diagnostic laboratories of the Mexican Social Security Institute between 2010 and 2016. Demographics, influenza positivity, seasonality, treatment choices and vaccination status analyses were performed for the vaccine according to its composition for each season. In all cases, both the different influenza subtypes and different age groups were considered separately. The circulation of A/H1N1pdm09 (48.7%), influenza A/H3N2 (21.1%), influenza B (12.6%), influenza A not subtyped (11%) and influenza A/H1N1 (6.6%) exhibited well-defined annual seasonality between November and March, and there were significant increases in the number of cases every 2 years. An inadequate use of oseltamivir was determined in 38% of cases, and the vaccination status in general varied between 12.1 and 18.5% depending on the season. Our results provide current information about influenza in Mexico and demonstrate the need to update both operational case definitions and medical practice guidelines to reduce the inappropriate use of antibiotics and antivirals.