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1.
PLoS One ; 16(7): e0253664, 2021.
Article in English | MEDLINE | ID: covidwho-1311283

ABSTRACT

BACKGROUND: The COVID-19 pandemic has had a profound worldwide impact. Vietnam, a lower middle-income country with limited resources, has successfully slowed this pandemic. The objectives of this report are to explore the impact of the COVID-19 pandemic on the research activities of an ongoing hypertension trial using a storytelling intervention in Vietnam. METHODS: Data were collected in a mixed-methods study among 86 patients and 10 health care workers participating in a clinical trial designed to improve hypertension control. Several questions related to the impact of COVID-19 on patient's daily activities and adherence to the study interventions were included in the follow-up visits. A focus group discussion was conducted among health care workers to discuss the impact of COVID-19 on research related activities. RESULTS: Fewer patients in the intervention group reported that they faced difficulties in adhering to prescribed study interventions, wanted to receive a call from a dedicated hotline, or have a visit from a community health worker as compared with those in the comparison group. Most study patients are willing to participate in future health research studies. When asked about the potential use of mobile phones in health research studies, fewer patients in the intervention group felt comfortable using a mobile phone for the delivery of intervention and interviews compared with those in the comparison condition. Community health workers shared that they visited patient's homes more often than previously due to the pandemic and health care workers had to perform more virus containment activities without a corresponding increase in ancillary staff. CONCLUSIONS: Both patients and health care workers in Vietnam faced difficulties in adhering to recommended trial interventions and procedures. Multiple approaches for intervention delivery and data collection are needed to overcome these difficulties during future health crises and enhance the implementation of future research studies. TRIAL REGISTRATION: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).


Subject(s)
COVID-19/epidemiology , Clinical Laboratory Services/standards , Clinical Trials as Topic , Medical Laboratory Personnel/psychology , Patients/psychology , Adult , Aged , Aged, 80 and over , Clinical Laboratory Services/statistics & numerical data , Female , Humans , Hypertension/epidemiology , Male , Middle Aged , Patient Compliance , Vietnam
2.
J Appl Lab Med ; 6(4): 998-1004, 2021 07 07.
Article in English | MEDLINE | ID: covidwho-1301365

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological assays have emerged as a response to the global pandemic, warranting studies evaluating their clinical performance. This study investigated 7 commercially available SARS-CoV-2 serological assays in samples from noninfected individuals and hospitalized patients. METHODS: SARS-CoV-2 qualitative serological assays by Abbott (IgG), Beckman (IgG), DiaSorin (IgG), EUROIMMUN (IgG and IgA), Roche and Bio-Rad (Total) were evaluated using specimens collected pre-December 2019 (n = 393), from nucleic acid amplification testing (NAAT) negative patients (n = 40), and from 53 patients with COVID-19 by NAAT collected 3-21 days post-onset of symptoms (POS) (N = 83). Negative agreement (NA), positive agreement (PA), and positive and negative predictive values (PPV and NPV) at prevalences of 5% and 10% were calculated. RESULTS: The overall %NA; 95% CI in the negative samples were: Roche 99.8%; 99.3-100.2, Beckman 99.8%; 98.7-100.0, Abbott and Bio-Rad 99.3%; 98.0-99.9, DiaSorin 98.4; 97.2-99.6, EUROIMMUN IgG 97.5%; 95.5-98.7, and EUROIMMUN IgA 79.7%; 75.9-83.5), accounting for positive/equivocal results as false positives. The %PA; 95% CI in samples collected 14+ days POS (n = 24) were: Bio-Rad 83.3%; 68.4-98.2, Abbott and Roche 79.2%; 62.9-95.4, EUROIMMUN IgA 70.8%; 52.6-89.0, Beckman 58.3%; 38.6-78.1, DiaSorin 54.2; 34.2-74.1, and EUROIMMUN IgG 50.0%; 30.0-70.0, accounting for negative/equivocal results as false negatives. NPVs ranged from 97.4%-98.9% and 94.7%-97.7% for prevalences 5% and 10%, respectively. PPVs ranged from 15.5%-94.8% and 27.9%-97.4% for prevalences 5% and 10%, respectively. CONCLUSION: The Roche and Beckman assays resulted in fewer false positives, followed by the Bio-Rad and Abbott assays. While the Bio-Rad assay demonstrated higher antibody detection in COVID-19-positive patients, PA claims cannot be established with a high level of confidence in our sample population.


Subject(s)
Antibodies, Viral/blood , COVID-19 Serological Testing/methods , COVID-19/diagnosis , Clinical Laboratory Services/statistics & numerical data , Clinical Laboratory Techniques/methods , Laboratories/statistics & numerical data , SARS-CoV-2/immunology , Antibodies, Viral/immunology , COVID-19/blood , COVID-19/virology , Case-Control Studies , Cohort Studies , Humans , Predictive Value of Tests , SARS-CoV-2/isolation & purification
4.
Diagn Microbiol Infect Dis ; 101(2): 115426, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1230428

ABSTRACT

OBJECTIVES: To quantify the workload and cost overload that the COVID-19 pandemic has meant for a Clinical Microbiology laboratory in a real-life scenario. METHODS: We compared the number of samples received, their distribution, the human resources, and the budget of a Microbiology laboratory in the COVID pandemic (March-December 2020) with the same months of the previous year. RESULTS: the total number of samples processed in the Clinical Microbiology laboratory in March to December 2020 increased 96.70% with respect to 2019 (from 246,060 to 483,993 samples), reflecting an increment of 127.50% when expressed as samples/1000 admissions (from 6057 to 13,780). The increase in workload was mainly at the expense of the virology (+2058%) and serology (+86%) areas. Despite additional personnel hiring, the samples processed per technician increased 12.5%. The extra cost attributed to Microbiology amounts to 6,616,511 euros (114.8%). CONCLUSIONS: This is the first study to provide quantitative figures about workload and cost increase caused by the COVID-19 in a Microbiology laboratory.


Subject(s)
COVID-19/epidemiology , Laboratories, Hospital/statistics & numerical data , COVID-19/diagnosis , COVID-19/economics , COVID-19 Testing/economics , COVID-19 Testing/statistics & numerical data , Clinical Laboratory Services/economics , Clinical Laboratory Services/statistics & numerical data , Costs and Cost Analysis , Hospitalization/statistics & numerical data , Humans , Laboratories, Hospital/economics , Medical Laboratory Personnel/economics , Medical Laboratory Personnel/statistics & numerical data , SARS-CoV-2/isolation & purification , Spain/epidemiology , Tertiary Care Centers , Workload/statistics & numerical data
5.
J Appl Lab Med ; 6(4): 998-1004, 2021 07 07.
Article in English | MEDLINE | ID: covidwho-1171309

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological assays have emerged as a response to the global pandemic, warranting studies evaluating their clinical performance. This study investigated 7 commercially available SARS-CoV-2 serological assays in samples from noninfected individuals and hospitalized patients. METHODS: SARS-CoV-2 qualitative serological assays by Abbott (IgG), Beckman (IgG), DiaSorin (IgG), EUROIMMUN (IgG and IgA), Roche and Bio-Rad (Total) were evaluated using specimens collected pre-December 2019 (n = 393), from nucleic acid amplification testing (NAAT) negative patients (n = 40), and from 53 patients with COVID-19 by NAAT collected 3-21 days post-onset of symptoms (POS) (N = 83). Negative agreement (NA), positive agreement (PA), and positive and negative predictive values (PPV and NPV) at prevalences of 5% and 10% were calculated. RESULTS: The overall %NA; 95% CI in the negative samples were: Roche 99.8%; 99.3-100.2, Beckman 99.8%; 98.7-100.0, Abbott and Bio-Rad 99.3%; 98.0-99.9, DiaSorin 98.4; 97.2-99.6, EUROIMMUN IgG 97.5%; 95.5-98.7, and EUROIMMUN IgA 79.7%; 75.9-83.5), accounting for positive/equivocal results as false positives. The %PA; 95% CI in samples collected 14+ days POS (n = 24) were: Bio-Rad 83.3%; 68.4-98.2, Abbott and Roche 79.2%; 62.9-95.4, EUROIMMUN IgA 70.8%; 52.6-89.0, Beckman 58.3%; 38.6-78.1, DiaSorin 54.2; 34.2-74.1, and EUROIMMUN IgG 50.0%; 30.0-70.0, accounting for negative/equivocal results as false negatives. NPVs ranged from 97.4%-98.9% and 94.7%-97.7% for prevalences 5% and 10%, respectively. PPVs ranged from 15.5%-94.8% and 27.9%-97.4% for prevalences 5% and 10%, respectively. CONCLUSION: The Roche and Beckman assays resulted in fewer false positives, followed by the Bio-Rad and Abbott assays. While the Bio-Rad assay demonstrated higher antibody detection in COVID-19-positive patients, PA claims cannot be established with a high level of confidence in our sample population.


Subject(s)
Antibodies, Viral/blood , COVID-19 Serological Testing/methods , COVID-19/diagnosis , Clinical Laboratory Services/statistics & numerical data , Clinical Laboratory Techniques/methods , Laboratories/statistics & numerical data , SARS-CoV-2/immunology , Antibodies, Viral/immunology , COVID-19/blood , COVID-19/virology , Case-Control Studies , Cohort Studies , Humans , Predictive Value of Tests , SARS-CoV-2/isolation & purification
6.
Lab Med ; 52(4): 311-314, 2021 Jul 01.
Article in English | MEDLINE | ID: covidwho-1135871

ABSTRACT

OBJECTIVE: Evidence has shown that Google searches for clinical symptom keywords correlates with the number of new weekly patients with COVID-19. This multinational study assessed whether demand for SARS-CoV-2 tests could also be predicted by Google searches for key COVID-19 symptoms. METHODS: The weekly number of SARS-CoV-2 tests performed in Italy and the United States was retrieved from official sources. A concomitant electronic search was performed in Google Trends, using terms for key COVID-19 symptoms. RESULTS: The model that provided the highest coefficient of determination for the United States (R2 = 82.8%) included a combination of searching for cough (with a time lag of 2 weeks), fever (with a time lag of 2 weeks), and headache (with a time lag of 3 weeks; the time lag refers to the amount of time between when a search was conducted and when a test was administered). In Italy, headache provided the model with the highest adjusted R2 (86.8%), with time lags of both 1 and 2 weeks. CONCLUSION: Weekly monitoring of Google Trends scores for nonspecific COVID-19 symptoms is a reliable approach for anticipating SARS-CoV-2 testing demands ~2 weeks in the future.


Subject(s)
COVID-19 Testing/statistics & numerical data , COVID-19 , Clinical Laboratory Services/statistics & numerical data , Search Engine/statistics & numerical data , COVID-19/diagnosis , COVID-19/epidemiology , Humans , Information Seeking Behavior , Laboratories , SARS-CoV-2
7.
J Glob Health ; 10(2): 020515, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-1106362

ABSTRACT

AIM: To compare different pooling methods in an attempt to improve the COVID-19 PCR diagnostic capacities. METHOD: We developed a novel information-dependent pooling protocol (indept), based on transmission of less informative sequential pools on to the next pooling cycle to maximize savings. We then compared it to the halving, generalized halving, splitting and hypercube protocols in a simulation study, across variety of scenarios. RESULTS: All five methods yielded various amount of test savings, which mostly depended on the virus prevalence in the population. In situations of low prevalence (up to 5%), indept had the best performance, requiring on average 20% of tests needed for singular testing across scenarios that were analyzed. Nevertheless, this comes at the expense of speed, with the worst-case scenario of indept protocol requiring up to twice the time needed to test the same number of samples in comparison to the hypercube protocol. In order to offset this, we developed a faster version of the protocol (indeptSp), which minimizes the number of terminal pools and manages to retain savings compared to other protocols, despite marginally longer processing times. CONCLUSION: The increasing demand for more testing globally can benefit from application of pooling, especially in resource-restrained situations of the low- and middle-income countries or situations of high testing demand. Singular testing in situations of low prevalence should be systematically discouraged.


Subject(s)
COVID-19 Nucleic Acid Testing/methods , COVID-19/diagnosis , Clinical Laboratory Services/supply & distribution , Health Services Needs and Demand/statistics & numerical data , SARS-CoV-2/isolation & purification , COVID-19/epidemiology , Clinical Laboratory Services/statistics & numerical data , Computer Simulation , Humans , Mass Screening/methods , SARS-CoV-2/genetics , Serologic Tests/methods , Specimen Handling/methods
8.
Diagn Microbiol Infect Dis ; 100(1): 115309, 2021 May.
Article in English | MEDLINE | ID: covidwho-1032803

ABSTRACT

Diagnostic microbiology services form a critical component of the response to infectious disease outbreaks. Like previous respiratory virus pandemics, the COVID-19 pandemic has placed significant strains on the standing capacity of laboratories around the world. In this case study, we describe the surge response required by our laboratory to meet the fluctuating demand for SARS-CoV-2 in our regional pathology service in Western Sydney, Australia between March and May 2020. While the overall number of SARS-CoV-2 PCR positive cases was relatively low compared to other Australian local health districts, testing numbers were highly unpredictable and changed on a weekly basis as local outbreaks were detected. As with other laboratories, numerous other challenges were also faced during this period, including the requirement to introduce a new and unaccredited diagnostic PCR assay for SARS-CoV-2, local and global shortages of reagents for sampling and sample processing, and a significant institutional SARS-CoV-2 outbreak in our laboratory catchment area. A successful service delivery during this period could only be maintained by a dynamic whole-of-laboratory and organizational response including (1) operational changes to the hours of service and the expansion of diagnostic testing at our laboratory site and other sites within our organization (2) careful management of specialist staff and re-training and recruitment of additional staff (3) changes to laboratory workflows to improve SARS-CoV-2 PCR test turnaround time and to accommodate limits to precious laboratory reagents; (4) clear communication within our laboratory and the NSW Health Pathology organization; and (5) collaborative co-ordination and support by NSW Health Pathology.


Subject(s)
COVID-19 Testing , COVID-19 , Laboratories/organization & administration , Microbiology , Australia , Clinical Laboratory Services/organization & administration , Clinical Laboratory Services/statistics & numerical data , Humans , Laboratories/supply & distribution , Medical Laboratory Personnel/education , Polymerase Chain Reaction , Time Factors
9.
ESMO Open ; 6(1): 100024, 2021 02.
Article in English | MEDLINE | ID: covidwho-1007937

ABSTRACT

BACKGROUND: This study evaluated the consequences in Europe of the COVID-19 outbreak on pathology laboratories orientated toward the diagnosis of thoracic diseases. MATERIALS AND METHODS: A survey was sent to 71 pathology laboratories from 21 European countries. The questionnaire requested information concerning the organization of biosafety, the clinical and molecular pathology, the biobanking, the workload, the associated research into COVID-19, and the organization of education and training during the COVID-19 crisis, from 15 March to 31 May 2020, compared with the same period in 2019. RESULTS: Questionnaires were returned from 53/71 (75%) laboratories from 18 European countries. The biosafety procedures were heterogeneous. The workload in clinical and molecular pathology decreased dramatically by 31% (range, 3%-55%) and 26% (range, 7%-62%), respectively. According to the professional category, between 28% and 41% of the staff members were not present in the laboratories but did teleworking. A total of 70% of the laboratories developed virtual meetings for the training of residents and junior pathologists. During the period of study, none of the staff members with confirmed COVID-19 became infected as a result of handling samples. CONCLUSIONS: The COVID-19 pandemic has had a strong impact on most of the European pathology laboratories included in this study. Urgent implementation of several changes to the organization of most of these laboratories, notably to better harmonize biosafety procedures, was noted at the onset of the pandemic and maintained in the event of a new wave of infection occurring in Europe.


Subject(s)
COVID-19/prevention & control , Clinical Laboratory Services/statistics & numerical data , Pathology, Clinical/statistics & numerical data , Pathology, Molecular/statistics & numerical data , Surveys and Questionnaires , Thoracic Diseases/diagnosis , Biological Specimen Banks/organization & administration , Biological Specimen Banks/statistics & numerical data , COVID-19/epidemiology , COVID-19/virology , Clinical Laboratory Services/trends , Containment of Biohazards/statistics & numerical data , Disease Outbreaks , Europe/epidemiology , Forecasting , Humans , Pandemics , Pathology, Clinical/methods , Pathology, Clinical/trends , Pathology, Molecular/methods , Pathology, Molecular/trends , SARS-CoV-2/isolation & purification , SARS-CoV-2/physiology , Specimen Handling/methods , Specimen Handling/statistics & numerical data , Thoracic Diseases/therapy
10.
Euro Surveill ; 25(47)2020 11.
Article in English | MEDLINE | ID: covidwho-976162

ABSTRACT

We present preliminary results of a coronavirus disease (COVID-19) impact assessment on testing for HIV, viral hepatitis and sexually transmitted infections in the WHO European Region. We analyse 98 responses from secondary care (n = 36), community testing sites (n = 52) and national level (n = 10). Compared to pre-COVID-19, 95% of respondents report decreased testing volumes during March-May and 58% during June-August 2020. Reasons for decreases and mitigation measures were analysed.


Subject(s)
Clinical Laboratory Services/statistics & numerical data , Coronavirus Infections , Coronavirus , Delivery of Health Care/statistics & numerical data , Health Impact Assessment , Mass Screening/statistics & numerical data , COVID-19 , Clinical Laboratory Services/trends , Delivery of Health Care/trends , Europe , HIV Infections/diagnosis , Hepatitis C/diagnosis , Hepatitis, Viral, Human/diagnosis , Humans , Male , Mass Screening/trends , Pandemics , SARS-CoV-2 , World Health Organization
11.
Ann Glob Health ; 86(1): 148, 2020 11 18.
Article in English | MEDLINE | ID: covidwho-953350

ABSTRACT

Background: Liberal PCR testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is key to contain the coronavirus disease 2019 (COVID-19) pandemic. Combined multi-sample testing in pools instead of single tests might enhance laboratory capacity and reduce costs, especially in low- and middle-income countries. Objective: The purpose of our study was to assess the value of a simple questionnaire to guide and further improve pooling strategies for SARS-CoV-2 laboratory testing. Methods: Pharyngeal swabs for SARS-CoV-2 testing were obtained from healthcare and police staff, hospital inpatients, and nursing home residents in the southwestern part of Germany. We designed a simple questionnaire, which included questions pertaining to a suggestive clinical symptomatology, recent travel history, and contact with confirmed cases to stratify an individual's pre-test probability of having contracted COVID-19. The questionnaire was adapted repeatedly in face of the unfolding pandemic in response to the evolving epidemiology and observed clinical symptomatology. Based on the response patterns, samples were either tested individually or in multi-sample pools. We compared the pool positivity rate and the number of total PCR tests required to obtain individual results between this questionnaire-based pooling strategy and randomly assembled pools. Findings: Between March 11 and July 5, 2020, we processed 25,978 samples using random pooling (n = 6,012; 23.1%) or questionnaire-based pooling (n = 19,966; 76.9%). The overall prevalence of SARS-CoV-2 was 0.9% (n = 238). Pool positivity (14.6% vs. 1.2%) and individual SARS-CoV-2 prevalence (3.4% vs. 0.1%) were higher in the random pooling group than in the questionnaire group. The average number of PCR tests needed to obtain the individual result for one participant was 0.27 tests in the random pooling group, as compared to 0.09 in the questionnaire-based pooling group, leading to a laboratory capacity increase of 73% and 91%, respectively, as compared to single PCR testing. Conclusions: Strategies that combine pool testing with a questionnaire-based risk stratification can increase laboratory testing capacities for COVID-19 and might be important tools, particularly in resource-constrained settings.


Subject(s)
COVID-19 Testing/methods , COVID-19 Testing/statistics & numerical data , COVID-19/diagnosis , COVID-19/epidemiology , SARS-CoV-2/isolation & purification , Surveys and Questionnaires , Clinical Laboratory Services/statistics & numerical data , Clinical Laboratory Services/supply & distribution , Germany/epidemiology , Humans , Pharynx/virology , Prevalence , Random Allocation , Reverse Transcriptase Polymerase Chain Reaction , Risk Factors
12.
J Appl Lab Med ; 6(2): 451-462, 2021 03 01.
Article in English | MEDLINE | ID: covidwho-949471

ABSTRACT

BACKGROUND: Patient surges beyond hospital capacity during the initial phase of the COVID-19 pandemic emphasized a need for clinical laboratories to prepare test processes to support future patient care. The objective of this study was to determine if current instrumentation in local hospital laboratories can accommodate the anticipated workload from COVID-19 infected patients in hospitals and a proposed field hospital in addition to testing for non-infected patients. METHODS: Simulation models predicted instrument throughput and turn-around-time for chemistry, ion-selective-electrode, and immunoassay tests using vendor-developed software with different workload scenarios. The expanded workload included tests from anticipated COVID patients in 2 local hospitals and a proposed field hospital with a COVID-specific test menu in addition to the pre-pandemic workload. RESULTS: Instrumentation throughput and turn-around time at each site was predicted. With additional COVID-patient beds in each hospital, the maximum throughput was approached with no impact on turnaround time. Addition of the field hospital workload led to significantly increased test turnaround times at each site. CONCLUSIONS: Simulation models depicted the analytic capacity and turn-around times for laboratory tests at each site and identified the laboratory best suited for field hospital laboratory support during the pandemic.


Subject(s)
COVID-19 Testing/instrumentation , COVID-19/diagnosis , Health Care Rationing/methods , Laboratories, Hospital/organization & administration , Pandemics/statistics & numerical data , COVID-19/epidemiology , COVID-19/virology , COVID-19 Testing/statistics & numerical data , COVID-19 Testing/trends , Clinical Laboratory Services/organization & administration , Clinical Laboratory Services/statistics & numerical data , Computer Simulation , Datasets as Topic , Forecasting/methods , Health Care Rationing/statistics & numerical data , Health Planning Technical Assistance , Hospital Bed Capacity/statistics & numerical data , Humans , Intensive Care Units/organization & administration , Intensive Care Units/statistics & numerical data , Intensive Care Units/trends , Laboratories, Hospital/supply & distribution , Laboratories, Hospital/trends , Models, Statistical , Reagent Kits, Diagnostic/supply & distribution , Reagent Kits, Diagnostic/trends , SARS-CoV-2/isolation & purification , Saskatchewan/epidemiology , Software , Time Factors , Workload/statistics & numerical data
13.
Ann Lab Med ; 41(2): 225-229, 2021 Mar 01.
Article in English | MEDLINE | ID: covidwho-874458

ABSTRACT

In response to the ongoing coronavirus disease 2019 (COVID-19) pandemic, an online laboratory surveillance system was established to monitor severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) real-time reverse transcription-PCR (rRT-PCR) testing capacities and results. SARS-CoV-2 rRT-PCR testing data were collected from 97 clinical laboratories, including 84 medical institutions and 13 independent clinical laboratories in Korea. We assessed the testing capacities to utilize SARS-CoV-2 rRT-PCR based on surveillance data obtained from February 7th to June 4th, 2020 and evaluated positive result characteristics according to the reagents used and sample types. A total of 1,890,319 SARS-CoV-2 rRT-PCR testing were performed, 2.3% of which were positive. Strong correlations were observed between the envelope (E) gene and RNA-dependent RNA polymerase (RdRp)/nucleocapsid (N) genes threshold cycle (Ct) values for each reagent. No statistically significant differences in gene Ct values were observed between the paired upper and lower respiratory tract samples, except in the N gene for nasopharyngeal swab and sputum samples. Our study showed that clinical laboratories in Korea have rapidly expanded their testing capacities in response to the COVID-19 outbreak, with a peak daily capacity of 34,193 tests. Rapid expansion in testing capacity is a critical component of the national response to the ongoing pandemic.


Subject(s)
Betacoronavirus/genetics , Clinical Laboratory Services/statistics & numerical data , Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , Betacoronavirus/isolation & purification , COVID-19 , Coronavirus Envelope Proteins , Coronavirus Infections/virology , Humans , Laboratories, Hospital , Pandemics , Pneumonia, Viral/virology , RNA, Viral/genetics , RNA, Viral/metabolism , RNA-Dependent RNA Polymerase/genetics , Real-Time Polymerase Chain Reaction , Republic of Korea , SARS-CoV-2 , Viral Envelope Proteins/genetics , Viral Proteins/genetics
14.
Ann Biol Clin (Paris) ; 78(5): 499-518, 2020 10 01.
Article in French | MEDLINE | ID: covidwho-836031

ABSTRACT

The French society of clinical biology "Biochemical markers of COVID-19" has set up a working group with the primary aim of reviewing, analyzing and monitoring the evolution of biological prescriptions according to the patient's care path and to look for markers of progression and severity of the disease. This study covers all public and private sectors of medical biology located in metropolitan and overseas France and also extends to the French-speaking world. This article presents the testimonies and data obtained for the "Overseas and French-speaking countries" sub-working group made up of 45 volunteer correspondents, located in 20 regions of the world. In view of the delayed spread of the SARS-CoV-2 virus, the overseas regions and the French-speaking regions have benefited from feedback from the first territories confronted with COVID-19. Thus, the entry of the virus or its spread in epidemic form could be avoided, thanks to the rapid closure of borders. The overseas territories depend very strongly on air and/or sea links with the metropolis or with the neighboring continent. The isolation of these countries is responsible for reagent supply difficulties and has necessitated emergency orders and the establishment of stocks lasting several months, in order to avoid shortages and maintain adequate patient care. In addition, in countries located in tropical or intertropical zones, the diagnosis of COVID-19 is complicated by the presence of various zoonoses (dengue, Zika, malaria, leptospirosis, etc.).


Subject(s)
Clinical Laboratory Services , Coronavirus Infections/diagnosis , Coronavirus Infections/epidemiology , Coronavirus Infections/therapy , Global Health/statistics & numerical data , Pneumonia, Viral/diagnosis , Pneumonia, Viral/epidemiology , Pneumonia, Viral/therapy , Travel Medicine/organization & administration , Adult , Africa/epidemiology , Aged , Aged, 80 and over , Belgium/epidemiology , Betacoronavirus/physiology , Biomarkers/analysis , Biomarkers/blood , COVID-19 , Cambodia/epidemiology , Child , Clinical Laboratory Services/organization & administration , Clinical Laboratory Services/statistics & numerical data , Contact Tracing/methods , Contact Tracing/statistics & numerical data , Coronavirus Infections/transmission , Diagnosis, Differential , Female , France/epidemiology , Hospitalization/statistics & numerical data , Humans , Infant, Newborn , Islands/epidemiology , Language , Laos/epidemiology , Louisiana/epidemiology , Male , Medical Laboratory Personnel/organization & administration , Medical Laboratory Personnel/statistics & numerical data , Middle Aged , Pandemics , Pneumonia, Viral/transmission , Retrospective Studies , SARS-CoV-2 , Surveys and Questionnaires , Survival Analysis , Travel Medicine/methods , Travel Medicine/statistics & numerical data , Travel-Related Illness , Tropical Climate , Tropical Medicine/methods , Tropical Medicine/organization & administration , Tropical Medicine/statistics & numerical data , Vietnam/epidemiology
15.
Lab Med ; 51(6): e83-e86, 2020 Nov 02.
Article in English | MEDLINE | ID: covidwho-766711

ABSTRACT

OBJECTIVE: Reorganization of the emergency department (ED) during the COVID-19 pandemic implied closure of the ED-dedicated laboratory and manual transport of all specimens to the dislocated central laboratory. The impact of such reorganization on laboratory turnaround time (TAT) was examined. METHODS: The TAT from blood sampling to specimen reception (TAT1), from specimen reception to test reporting (TAT2), and from sampling to test reporting (TAT3) were compared between the pandemic peak month in 2020 and the same month in 2019. We evaluated whether TAT2 fulfills the recommended 60-minute criteria. RESULTS: A statistically significant difference was observed for all comparisons (P <.001), with TAT1 prominently contributing to TAT3 prolongation (from 48 minutes to 108 minutes) and exceeding the recommended 60-minute criteria. The TAT2 was extended from 33 minutes to 49 minutes. CONCLUSION: An ED reorganization compromised the usual laboratory services for patients in the ED, with manual specimen delivery being the main cause for TAT prolongation.


Subject(s)
Clinical Laboratory Services/statistics & numerical data , Laboratories, Hospital , Specimen Handling/statistics & numerical data , COVID-19 , Coronavirus Infections , Humans , Pandemics , Pneumonia, Viral , Time Factors
16.
Ann Biol Clin (Paris) ; 78(4): 363-382, 2020 08 01.
Article in French | MEDLINE | ID: covidwho-709296

ABSTRACT

The point-of-care tests (POCT) are subject to accreditation. A national inventory survey provides a synthesis of knowledge. The survey distributed 31 questions in 2019. 147 responses were received (75% biologists, 49% CHU, 42% CHG). Only 20.41% are accredited ISO22870, the majority for <50% of the medical departments; 70% say they are going there at the end of 2019 or in 2020. The maps are unknown for 32% (EBMD) and 82% (TROD). Visibility is poor with: medical establishment committee (40%), IT department (31%). Connection is necessary for 87-95% depending on the criterion (QC, authorizations, etc.) and 66% of answers highlight that less than 50% of connexion is effective. The major advantage is the delay of the result (62.5%), then the relationship with the health teams (33.3%). The disadvantages: difficulty of the quality approach (45%), cost of tests (34.3%). Human resource requirements are identified for technicians (82%) and biologists (76%). The multiplicity of sites, devices and operators means that it is difficult to set up and maintain. Biology outside the laboratories, under biological responsibility, must meet a rigorous imperative quality approach.


Subject(s)
Clinical Laboratory Techniques , Global Health , Laboratories/statistics & numerical data , Laboratories/standards , Point-of-Care Testing , Accreditation , COVID-19 , COVID-19 Testing , Clinical Laboratory Services/standards , Clinical Laboratory Services/statistics & numerical data , Clinical Laboratory Techniques/standards , Clinical Laboratory Techniques/statistics & numerical data , Coronavirus Infections/diagnosis , Coronavirus Infections/epidemiology , France/epidemiology , Global Health/standards , Global Health/statistics & numerical data , History, 21st Century , Humans , Internationality , Laboratory Proficiency Testing/standards , Pandemics , Pneumonia, Viral/diagnosis , Pneumonia, Viral/epidemiology , Point-of-Care Systems/standards , Point-of-Care Systems/statistics & numerical data , Point-of-Care Testing/organization & administration , Point-of-Care Testing/standards , Point-of-Care Testing/statistics & numerical data , Quality Assurance, Health Care/organization & administration , Surveys and Questionnaires
17.
J Appl Lab Med ; 5(6): 1194-1205, 2020 11 01.
Article in English | MEDLINE | ID: covidwho-646320

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) was formally characterized as a pandemic on March 11, 2020. Since that time, the COVID-19 pandemic has led to unprecedented demand for healthcare resources. The purpose of this study was to identify changes in laboratory test utilization in the setting of increasing local incidence of COVID-19. METHODS: We performed a retrospective assessment of laboratory test order and specimen container utilization at a single, urban tertiary care medical center. Data were extracted from the laboratory information system database over a 10-week period, spanning the primordial inflection of COVID-19 incidence in our region. Total testing volumes were calculated during the first 2 and last 2 weeks of the observation period and used as reference points to examine the absolute and relative differences in test order volume between the prepandemic and COVID-19 surge periods. RESULTS: Between February 2, 2020, and April 11, 2020, there were 873 397 tests ordered and final verified. The in-house SARS-CoV-2 PCR positivity rate for admitted patients in the last week of the observation period was 30.8%. Significant increases in workload were observed in the send-out laboratory section and for COVID-19 diagnosis (PCR) and management-related testing. Otherwise, there was a net decrease in overall demand across nearly all laboratory sections. Increases in testing were noted for tests related to COVID-19 management. Viral transport media and citrated blue top containers demonstrated increases in utilization. CONCLUSION: Increasing local incidence of COVID-19 had a profound impact on laboratory operations. While volume increases were seen for laboratory tests related to COVID-19 diagnostics and management, including some with limited evidence to support their use, overall testing volumes decreased substantially. During events such as COVID-19, monitoring of such patterns can help inform laboratory management, staffing, and test stewardship recommendations for managing resource and supply availability.


Subject(s)
Betacoronavirus/isolation & purification , Clinical Laboratory Services/statistics & numerical data , Clinical Laboratory Techniques/statistics & numerical data , Coronavirus Infections/diagnosis , Facilities and Services Utilization/statistics & numerical data , Pneumonia, Viral/diagnosis , COVID-19 , COVID-19 Testing , Coronavirus Infections/epidemiology , Coronavirus Infections/virology , Humans , Incidence , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , Polymerase Chain Reaction/statistics & numerical data , Reagent Kits, Diagnostic/statistics & numerical data , Retrospective Studies , SARS-CoV-2 , Specimen Handling/instrumentation , Specimen Handling/statistics & numerical data
18.
Arch Pathol Lab Med ; 144(11): 1321-1324, 2020 11 01.
Article in English | MEDLINE | ID: covidwho-639712

ABSTRACT

CONTEXT.­: Declining reimbursement shifts hospital laboratories from system assets to cost centers. This has resulted in increased outsourcing of laboratory services, which can jeopardize a hospital systems' ability to respond to a health care crisis. OBJECTIVES.­: To demonstrate that investment in a core laboratory serving an academic medical center equipped a regional health system to respond to the Coronavirus disease 2019 (COVID-19) pandemic. DESIGN.­: COVID-19 diagnostic testing data were analyzed. Volumes were evaluated by result date (March 16, 2020-May 6, 2020), and the average of received-to-verified turnaround time was calculated and compared for in-house and send-out testing, and different in-house testing methodologies. RESULTS.­: Daily viral diagnostic testing capacity increased by greater than 3000% (from 21 tests per day to 658 tests per day). Total viral diagnostic testing reported by the core laboratory increased by 128 times during 22 days of test method validation and 826 times during the analysis period, while average turnaround time per day for send-out testing increased from 3.7 days to 21 days. Decreased overall average turnaround time was observed at the core laboratory (0.45 days) versus send-out testing (7.63 days) (P < .001). CONCLUSIONS.­: Investment in a core laboratory provided the health system with the necessary expertise and resources to mount a robust response to the pandemic. Local access to testing allowed rapid triage of patients and conservation of scarce personal protective equipment (PPE). In addition, the core laboratory was able to support regional health departments and several hospitals outside of the system.


Subject(s)
Betacoronavirus/isolation & purification , Clinical Laboratory Techniques/methods , Coronavirus Infections/diagnosis , Laboratories, Hospital , Pneumonia, Viral/diagnosis , Academic Medical Centers/standards , Academic Medical Centers/statistics & numerical data , Betacoronavirus/physiology , COVID-19 , COVID-19 Testing , Clinical Laboratory Services/standards , Clinical Laboratory Services/statistics & numerical data , Coronavirus Infections/prevention & control , Coronavirus Infections/virology , Delivery of Health Care/standards , Delivery of Health Care/statistics & numerical data , Humans , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Pneumonia, Viral/virology , Reproducibility of Results , SARS-CoV-2
19.
Bioanalysis ; 12(17): 1223-1230, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-612148

ABSTRACT

Coronavirus disease 2019 emergency has created an enormous stress on providers that have been transformed into coronavirus disease hospitals. This article presents the experience of the clinical laboratory of Spedali Civili in Brescia (a teaching hospital in Lombardy with over 1500 beds) in managing the crisis, and to offer practical considerations for laboratory testing for this cohort of patients. Our contribution is threefold: by comparing the demand for tests in two representative period before and within the crisis, we show the change in compositions of the analytes that other labs may expect; we present the new panels of tests that hospital staff can order with different advantage for wards and laboratory; and we show how to reorganize staff on the basis of changes mentioned above.


Subject(s)
Clinical Laboratory Services/statistics & numerical data , Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , Betacoronavirus/isolation & purification , COVID-19 , Coronavirus Infections/epidemiology , Coronavirus Infections/virology , Disease Outbreaks , Ferritins/blood , Fibrin Fibrinogen Degradation Products/analysis , Hospitals, Teaching , Humans , Italy/epidemiology , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , SARS-CoV-2 , Urinalysis
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