External quality assessment for laboratories in pan-India ILI/SARI surveillance for simultaneous detection of influenza virus and SARS-CoV-2
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SUBMITTER: Potdar V
PROVIDER: S-EPMC10679675 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundOver time, COVID-19 testing has significantly declined across the world. However, it is critical to monitor the virus through surveillance. In late 2020, WHO released interim guidance advising the use of the existing Global Influenza Surveillance and Response System (GISRS) for the integrated surveillance of influenza and SARS-CoV-2.MethodsIn July 2021, we initiated a pan-India integrated surveillance for influenza and SARS-CoV-2 through the geographically representative network of Virus Research and Diagnostic Laboratories (VRDLs) across 26 hospital and laboratory sites and 70 community sites. A total of 34,260 cases of influenza-like illness (ILI) and Severe acute respiratory infection (SARI) were enrolled from 4 July 2021 to 31 October 2022.FindingsInfluenza A(H3) and B/Victoria dominated during 2021 monsoon season while A(H1N1)pdm09 dominated during 2022 monsoon season. The SARS-CoV-2 "variants of concern" (VoC) Delta and Omicron predominated in 2021 and 2022, respectively. Increased proportion of SARI was seen in extremes of age: 90% cases in < 1 year; 68% in 1 to 5 years and 61% in ≥ 8 years age group. Approximately 40.7% of enrolled cases only partially fulfilled WHO ILI and SARI case definitions. Influenza- and SARS-CoV-2-infected comorbid patients had higher risks of hospitalization, ICU admission, and oxygen requirement.InterpretationThe results depicted the varying strains and transmission dynamics of influenza and SARS-CoV-2 viruses over time, thus emphasizing the need to continue and expand surveillance across countries for improved decision making. The study also describes important information related to clinical outcomes of ILI and SARI patients and highlights the need to review existing WHO ILI and SARI case definitions.
| S-EPMC10624221 | biostudies-literature
Project description:Sudden emergence and rapid spread of COVID-19 created an inevitable need for expansion of the COVID-19 laboratory testing network across the world. The strategy to test-track-treat was advocated for quick detection and containment of the disease. Being the second most populous country in the world, India was challenged to make COVID-19 testing available and accessible in all parts of the country. The molecular laboratory testing network was augmented expeditiously, and number of laboratories was increased from one in January 2020 to 2951 till mid-September, 2021. This rapid expansion warranted the need to have inbuilt systems of quality control/ quality assurance. In addition to the ongoing inter-laboratory quality control (ILQC), India implemented an External Quality Assurance Program (EQAP) with assistance from World Health Organization (WHO) and Royal College of Pathologists, Australasia. Out of the 953 open system rRTPCR laboratories in both public and private sector who participated in the first round of EQAP, 891(93.4%) laboratories obtained a passing score of > = 80%. The satisfactory performance of Indian COVID-19 testing laboratories has boosted the confidence of the public and policy makers in the quality of testing. ILQC and EQAP need to continue to ensure adherence of the testing laboratories to the desired quality standards.
| S-EPMC8824319 | biostudies-literature
Project description:Objective The objective was to forecast and validate prediction estimates of influenza activity in Houston, TX using four years of historical influenza-like illness (ILI) from three surveillance data capture mechanisms. Background Using novel surveillance methods and historical data to estimate future trends of influenza-like illness can lead to early detection of influenza activity increases and decreases. Anticipating surges gives public health professionals more time to prepare and increase prevention efforts. Methods Data was obtained from three surveillance systems, Flu Near You, ILINet, and hospital emergency center (EC) visits, with diverse data capture mechanisms. Autoregressive integrated moving average (ARIMA) models were fitted to data from each source for week 27 of 2012 through week 26 of 2016 and used to forecast influenza-like activity for the subsequent 10 weeks. Estimates were then compared to actual ILI percentages for the same period. Results Forecasted estimates had wide confidence intervals that crossed zero. The forecasted trend direction differed by data source, resulting in lack of consensus about future influenza activity. ILINet forecasted estimates and actual percentages had the least differences. ILINet performed best when forecasting influenza activity in Houston, TX. Conclusion Though the three forecasted estimates did not agree on the trend directions, and thus, were considered imprecise predictors of long-term ILI activity based on existing data, pooling predictions and careful interpretations may be helpful for short term intervention efforts. Further work is needed to improve forecast accuracy considering the promise forecasting holds for seasonal influenza prevention and control, and pandemic preparedness.
| S-EPMC5630275 | biostudies-literature
Project description:IntroductionTajikistan has a laboratory network with three levels of tuberculosis (TB) laboratories. The external quality assessment (EQA) of sputum smear microscopy was implemented in 2007. The objective of this study was to evaluate the EQA system and identify potential performance improvement strategies in TB microscopic laboratories in Sughd, Tajikistan.MethodsThis is a cross-sectional study based on retrospective record review and secondary data analyses on Acid-Fast Bacilli (AFB) microscopy data and EQA reading results collected between the first quarter of 2011 and the fourth quarter of 2013. Descriptive analyses were conducted to examine the overview of microscopy laboratories activities, EQA results, and laboratory performance.ResultOf the 123,874 smears examined between 2011 and 2013, 11,522 (9.30%) were re-checked by the EQA system. The population TB screening rate rose from 0.46% in 2011 to 0.57% in 2013, and the case positivity rate decreased from 6.98% to 4.80%. The regional EQA results showed a reduction in high false-positive, high false-negative, and low false-negative errors. False-positive errors had decreased from 0.13% in 2011 to 0.07% in 2013, and false-negative errors from 0.91% in 2011 to 0.15% in 2013. Regional sensitivity of smear microscopy, when compared to re-checking controller, increased from 88.2% in 2011 to 97.2% in 2013. The regional specificity level remained relatively stable at above 99%.ConclusionOur study found that a decreasing trend of case positivity rate from 2011 to 2013 in Sughd, though the overall laboratory workload was on the rise. In addition, EQA results showed an overall error reduction and an improved sensitivity of smear microscopy in the region. The overview of microscopic laboratory activities and the actual evaluation of the EQA system on sputum smear microscopy complement each other in providing a better picture on the progress of TB laboratory strengthening. We recommend similar approaches to be adapted by future evaluations on TB microscopic laboratories, particularly among countries of high burden. Interactive training and feedback loops are crucial to improving TB surveillance in Tajikistan.
| S-EPMC5661208 | biostudies-literature
Project description:BackgroundInfluenza surveillance is important to identify circulating, emerging/reemerging strains and unusual epidemiological trends. With these objectives, a multisite human influenza surveillance network was initiated in India in 2004.MethodsEpidemiologic data and throat swabs for laboratory testing were collected from patients with influenza-like illness (ILI) and severe acute respiratory infections (SARI). Virus isolation was carried out in Madin-Darby canine kidney cells and strains identified by hemagglutination inhibition assay. Meteorological data were collected.ResultsFrom September 2004 to December 2008, 617 (4·43%) of 13928 cases yielded isolates: 27·8% were influenza A(H1N1), 29·8% were type A(H3N2), and 42·3% were type B. The yearly type and subtype distribution varied significantly from site to site. Peak influenza activity was observed from June to August in Delhi, Pune, and Kolkata and October to December in Chennai. Maximum influenza activity was seen during the rains in Delhi, Pune, Chennai, and Kolkata in correlation with virus isolations. Multivariate analysis of ILI cases showed chill/rigors, cough, fatigue, and ILI in family, correlated positively with isolation. Genetic analysis of Indian isolates revealed that viruses matched with vaccine strains by and large. Overlapping between circulating and vaccine component strains of consecutive years was also observed.ConclusionsSeasonal influenza A(H1N1), H3N2, and type B co-circulated in all regions without any particular pattern of movement of any subtype. Year-round limited influenza activity with peaks during rains was observed. Genetic drifts and varying seasonality in different parts of the country suggest that a staggered timing of vaccination may be appropriate for India.
| S-EPMC5657135 | biostudies-literature
Project description:In this paper, we consider the yearly influenza epidemic, as reflected in the seasonal surveillance data compiled by the CDC (Center for Disease Control and Prevention, USA) and we explore a new methodology for comparing specific features of these data. In particular, we focus on the ten HHS (Health and Human Services) regions, and how the incidence data evolves in these regions. In order to perform the comparisons, we consider the relative distribution of weekly new cases over one season and replace the crude data with predicted values. These predictions are obtained after fitting a negative binomial regression model that controls for important covariates. The prediction is computed on a 'generic' set of covariate values that takes into account the relative size (population wise) of the regions to be compared. The main results are presented in graphical form, that quickly emphasizes relevant features of the seasonal data and facilitates the comparisons.
| S-EPMC6363783 | biostudies-literature
Project description:BackgroundCountries worldwide are focusing to mitigate the ongoing SARS-CoV-2 pandemic by employing public health measures. Laboratories have a key role in the control of SARS-CoV-2 transmission. Serology for SARS-CoV-2 is of critical importance to support diagnosis, define the epidemiological framework and evaluate immune responses to natural infection and vaccine administration.AimThe aim of this study was the assessment of the actual capability among laboratories involved in sero-epidemiological studies on COVID-19 in EU/EEA and EU enlargement countries to detect SARS-CoV-2 antibodies through an external quality assessment (EQA) based on proficiency testing.MethodsThe EQA panels were composed of eight different, pooled human serum samples (all collected in 2020 before the vaccine roll-out), addressing sensitivity and specificity of detection. The panels and two EU human SARS-CoV-2 serological standards were sent to 56 laboratories in 30 countries.ResultsThe overall performance of laboratories within this EQA indicated a robust ability to establish past SARS-CoV-2 infections via detection of anti-SARS-CoV-2 antibodies, with 53 of 55 laboratories using at least one test that characterised all EQA samples correctly. IgM-specific test methods provided most incorrect sample characterisations (24/208), while test methods detecting total immunoglobulin (0/119) and neutralising antibodies (2/230) performed the best. The semiquantitative assays used by the EQA participants also showed a robust performance in relation to the standards.ConclusionOur EQA showed a high capability across European reference laboratories for reliable diagnostics for SARS-CoV-2 antibody responses. Serological tests that provide robust and reliable detection of anti-SARS-CoV-2 antibodies are available.
| S-EPMC9585882 | biostudies-literature
Project description:BackgroundWorldwide, an increase in antimicrobial resistance (AMR) of Neisseria gonorrhoeae has been observed. Until now, no protocol for an external quality assessment (EQA) has been available for Germany. The German gonococcal resistance network (GORENET) performed an EQA of primary laboratories in Germany in order to assess quality of antibiotic susceptibility testing, to gain information about laboratory procedures and to assess the impact of these procedures on test results.MethodsLaboratories assessed drug susceptibility to cefixime, ceftriaxone, azithromycin, penicillin and ciprofloxacin for five N. gonorrhoeae strains, using their standard laboratory protocols. Minimal inhibitory concentrations (MICs) were compared to World Health Organisation (WHO) consensus results (or, if not available, reference laboratory results), while deviation by +/- one doubling dilution was accepted. Data on laboratory procedures were collected via a standardised questionnaire. Generalized linear models and conditional inference trees (CTREE) were used to assess relationships between laboratory procedures and testing outcomes.ResultsTwenty-one primary laboratories participated in the EQA in June 2018. 96% of ciprofloxacin MICs were reported within accepted deviations, as well as 88% for cefixime, 85% for ceftriaxone, 79% for penicillin and 70% for azithromycin. The use of interpretation standards and general laboratory procedures like agar base, incubation settings or the use of control strains strongly differed between laboratories. In statistical analysis, incubation time of cultures < 24 h was associated with correct measurements. Additionally, a 5% CO2 concentration was associated with correct results regarding azithromycin compared to 3%. CTREE analysis showed that incubation time, humidity and CO2 concentration had the greatest influence on the average deviation from consensus results.ConclusionsIn conclusion, we report the development of a protocol for N. gonorrhoeae antimicrobial susceptibility testing in Germany. While testing results were in accordance with the expected consensus results in 70-96%, depending on the antibiotic agent, laboratory methodology was heterogeneous and may significantly affect the testing quality. We therefore recommend the development of a standard operating procedure (SOP) for N. gonorrhoeae susceptibility testing in Germany.
| S-EPMC7366306 | biostudies-literature
Project description:Acute respiratory infections (ARIs) are a leading cause of death in children under five globally. The seasonal trends and profiles of respiratory viruses vary by region and season. Due to limited information and the population's vulnerability, we conducted the hospital-based surveillance of respiratory viruses in Eastern Uttar Pradesh. Throat and nasal swabs were collected from outpatients and inpatients in the Department of Paediatrics, Baba Raghav Das (BRD) Medical College, Gorakhpur, between May 2022 and April 2023. A total of 943 samples from children aged 1 to 60 months were tested using multiplex real-time PCR for respiratory viruses in cases of ARI and SARI. Out of 943 samples tested, the highest positivity was found for parainfluenza virus [105 (11.13%) PIV-1 (79), PIV-2 (18), PIV-4 (18)], followed by adenovirus [82 (8.7%), RSV-B, [68 (7.21%)], influenza-A [46(4.9%): H1N1 = 29, H3N2 = 14), SARS CoV-2 [28 (3%)], hMPV [13(1.4%), RSV-A [4 (0.42%), and influenza-B (Victoria lineage) 1 (0.10%). The maximum positivity of respiratory viruses was seen in children between 1 to 12 months. The wide variation in prevalence of these respiratory viruses was seen in different seasons. This study enhances understanding of the seasonal and clinical trends of respiratory virus circulation and co-infections in Eastern Uttar Pradesh. The findings highlight the importance of targeted interventions to reduce the burden of respiratory infections in this region.
| S-EPMC11769465 | biostudies-literature
Project description:(1) Background: Laboratories supporting the invasive bacteria preventable disease (IB-VPD) network are expected to demonstrate the capacity to identify the main etiological agents of pediatric bacterial meningitis (PBM) (Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae) on Gram stains and in phenotypic identification. Individual reports of sentinel site (SSL), national (NL) and regional reference (RRL) laboratories participating in the World Health Organization (WHO)-coordinated external quality assessment, distributed by the United Kingdom National External Quality Assessment (EQA) Services (UK NEQAS) for Microbiology between 2014 and 2019 were analyzed. (2) Methods: The panels consisted of (1) unstained bacterial smears for Gram staining, (2) viable isolates for identification and serotyping/serogrouping (ST/SG) and (3) simulated cerebral spinal fluid (CSF) samples for species detection and ST/SG using polymerase chain reaction (PCR). SSLs and NLs tested for Gram staining and species identification (partial panel). RRLs, plus any SSLs and NLs (optionally) also analyzed the simulated CSF samples (full panel). The passing score was ≥75% for NLs and SSLs, and ≥90% for RRLs and NLs/SSLs testing the full panel. (3) Results: Overall, 63% (5/8) of the SSLs and NLs were able to correctly identify the targeted pathogens, in 2019; but there were challenges to identify Haemophilus influenzae either on Gram stains (35% of the labs failed 2014), or in culture. Individual performance showed inconsistent capacity, with only 39% (13/33) of the SSLs/NLs passing the EQA exercise throughout all surveys in which they participated. RRLs performed well over the study period, but one of the two failed to reach the minimal passing score in 2016 and 2018; while the SSLs/NLs that optionally tested the full panel scored between 75% and 90% (intermediate pass category). (4) Conclusions: We identified a need for implementing a robust quality management system for timely identification of the gaps and then implementing corrective and preventive actions, in addition to continuous refresher training in the SSLs and NLs supporting the IB-VPD surveillance in the World Health Organization, Regional Office for Africa (WHO AFRO).
| S-EPMC10459392 | biostudies-literature