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1.
J Clin Microbiol ; 58(11)2020 10 21.
Article in English | MEDLINE | ID: covidwho-889842

ABSTRACT

The coronavirus disease (COVID-19) pandemic has placed the clinical laboratory and testing for SARS-CoV-2 front and center in the worldwide discussion of how to end the outbreak. Clinical laboratories have responded by developing, validating, and implementing a variety of molecular and serologic assays to test for SARS-CoV-2 infection. This has played an essential role in identifying cases, informing isolation decisions, and helping to curb the spread of disease. However, as the demand for COVID-19 testing has increased, laboratory professionals have faced a growing list of challenges, uncertainties, and, in some situations, controversy, as they have attempted to balance the need for increasing test capacity with maintaining a high-quality laboratory operation. The emergence of this new viral pathogen has raised unique diagnostic questions for which there have not always been straightforward answers. In this commentary, the author addresses several areas of current debate, including (i) the role of molecular assays in defining the duration of isolation/quarantine, (ii) whether the PCR cycle threshold value should be included on patient reports, (iii) if specimen pooling and testing by research staff represent acceptable solutions to expand screening, and (iv) whether testing a large percentage of the population is feasible and represents a viable strategy to end the pandemic.


Subject(s)
Betacoronavirus/isolation & purification , Clinical Laboratory Techniques , Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , Betacoronavirus/genetics , Betacoronavirus/immunology , Clinical Laboratory Services/standards , Coronavirus Infections/prevention & control , Humans , Mass Screening , Medical Laboratory Personnel/standards , Molecular Diagnostic Techniques/standards , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Polymerase Chain Reaction/standards , Quarantine/standards , Sensitivity and Specificity , Specimen Handling
2.
Ann Biol Clin (Paris) ; 78(4): 363-382, 2020 Aug 01.
Article in English | 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 , 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
3.
J Clin Microbiol ; 58(11)2020 10 21.
Article in English | MEDLINE | ID: covidwho-708710

ABSTRACT

The coronavirus disease (COVID-19) pandemic has placed the clinical laboratory and testing for SARS-CoV-2 front and center in the worldwide discussion of how to end the outbreak. Clinical laboratories have responded by developing, validating, and implementing a variety of molecular and serologic assays to test for SARS-CoV-2 infection. This has played an essential role in identifying cases, informing isolation decisions, and helping to curb the spread of disease. However, as the demand for COVID-19 testing has increased, laboratory professionals have faced a growing list of challenges, uncertainties, and, in some situations, controversy, as they have attempted to balance the need for increasing test capacity with maintaining a high-quality laboratory operation. The emergence of this new viral pathogen has raised unique diagnostic questions for which there have not always been straightforward answers. In this commentary, the author addresses several areas of current debate, including (i) the role of molecular assays in defining the duration of isolation/quarantine, (ii) whether the PCR cycle threshold value should be included on patient reports, (iii) if specimen pooling and testing by research staff represent acceptable solutions to expand screening, and (iv) whether testing a large percentage of the population is feasible and represents a viable strategy to end the pandemic.


Subject(s)
Betacoronavirus/isolation & purification , Clinical Laboratory Techniques , Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , Betacoronavirus/genetics , Betacoronavirus/immunology , Clinical Laboratory Services/standards , Coronavirus Infections/prevention & control , Humans , Mass Screening , Medical Laboratory Personnel/standards , Molecular Diagnostic Techniques/standards , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Polymerase Chain Reaction/standards , Quarantine/standards , Sensitivity and Specificity , Specimen Handling
4.
Am J Clin Pathol ; 154(4): 475-478, 2020 09 08.
Article in English | MEDLINE | ID: covidwho-705105

ABSTRACT

OBJECTIVES: At the onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in the United States, testing was limited to the Centers for Disease Control and Prevention-developed reverse transcription polymerase chain reaction assay. The urgent and massive demand for testing prompted swift development of assays to detect SARS-CoV-2. The objective of this study was to assess the accuracy of these newly developed tests. METHODS: The American Proficiency Institute sent 2 test samples to 346 clinical laboratories in order to assess the accuracy of SARS-CoV-2 assays. The positive sample, containing 5,175 viral copies/mL, was fully extractable with SARS-CoV-2 viral capsid protein and RNA. The negative sample, with 3,951 viral copies/mL, contained recombinant virus particles with sequences for targeting human RNAase P gene sequences. RESULTS: Of the laboratories submitting results, 97.4% (302/310) correctly detected the virus when present and 98.3% (296/301) correctly indicated when the virus was not present. Among incorrect results reported in this proficiency challenge, 76.9% (10/13) were likely related to clerical error. This accounts for 1.6% (10/611) of all reported results. CONCLUSIONS: Overall performance in this SARS-CoV-2 RNA detection challenge was excellent, providing confidence in the results of these new molecular tests and assurance for the clinical and public health decisions based on these test results.


Subject(s)
Betacoronavirus/isolation & purification , Clinical Laboratory Services/standards , Clinical Laboratory Techniques/standards , Coronavirus Infections/diagnosis , Laboratory Proficiency Testing , Pneumonia, Viral/diagnosis , Betacoronavirus/genetics , Clinical Laboratory Techniques/methods , Humans , Pandemics , RNA, Viral/analysis , RNA, Viral/isolation & purification , United States
5.
Am J Clin Pathol ; 154(4): 475-478, 2020 09 08.
Article in English | MEDLINE | ID: covidwho-656496

ABSTRACT

OBJECTIVES: At the onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in the United States, testing was limited to the Centers for Disease Control and Prevention-developed reverse transcription polymerase chain reaction assay. The urgent and massive demand for testing prompted swift development of assays to detect SARS-CoV-2. The objective of this study was to assess the accuracy of these newly developed tests. METHODS: The American Proficiency Institute sent 2 test samples to 346 clinical laboratories in order to assess the accuracy of SARS-CoV-2 assays. The positive sample, containing 5,175 viral copies/mL, was fully extractable with SARS-CoV-2 viral capsid protein and RNA. The negative sample, with 3,951 viral copies/mL, contained recombinant virus particles with sequences for targeting human RNAase P gene sequences. RESULTS: Of the laboratories submitting results, 97.4% (302/310) correctly detected the virus when present and 98.3% (296/301) correctly indicated when the virus was not present. Among incorrect results reported in this proficiency challenge, 76.9% (10/13) were likely related to clerical error. This accounts for 1.6% (10/611) of all reported results. CONCLUSIONS: Overall performance in this SARS-CoV-2 RNA detection challenge was excellent, providing confidence in the results of these new molecular tests and assurance for the clinical and public health decisions based on these test results.


Subject(s)
Betacoronavirus/isolation & purification , Clinical Laboratory Services/standards , Clinical Laboratory Techniques/standards , Coronavirus Infections/diagnosis , Laboratory Proficiency Testing , Pneumonia, Viral/diagnosis , Betacoronavirus/genetics , Clinical Laboratory Techniques/methods , Humans , Pandemics , RNA, Viral/analysis , RNA, Viral/isolation & purification , United States
7.
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 , 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
9.
Ann Biol Clin (Paris) ; 78(3): 269-277, 2020 Jun 01.
Article in English | MEDLINE | ID: covidwho-608309

ABSTRACT

The SARS-CoV-2 virus is responsible for an epidemic disease called COVID-19, which was initially evidenced in Wuhan, China, and spread very rapidly in China and around the world. In France, the first isolated case seems now to be reported in December 2019, stage 3 of the COVID-19 epidemic was triggered on March 14th, the start of the planned containment exit from May 11th. Healthcare services have faced a large influx of patients who may be beyond their capacity to receive and care, particularly in the Large-East and Ile-de-France regions. Some patients show an evolution of the disease never observed before with other coronaviruses and develop in a few days a very important inflammatory reaction, which can lead to death of patients. A working group of the French Society of Clinical Biology (SFBC) was set up with the objective of providing updated information on the current status of the biological prescriptions (focusing on biochemistry ones) and their evolution during the epidemic, and of analyzing the biological parameters associated with comorbidities and patient evolution in order to link biological results with medical events. The expanded working group covers all sectors of medical biology in France and extends to the French-speaking world: hospital sectors (CHU and CH, Army Training Hospitals) and the private sector opening a field of view on the biological situation in establishments for dependent elderly, social establishments and clinical medical institutions. The purpose of this article is the presentation of this working group and its immediate and future actions.


Subject(s)
Betacoronavirus , Biochemistry/organization & administration , Biomarkers/analysis , Clinical Laboratory Services/organization & administration , Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , Societies, Scientific/organization & administration , Betacoronavirus/isolation & purification , Betacoronavirus/pathogenicity , Biochemistry/standards , Biomarkers/blood , Clinical Laboratory Services/standards , Community Networks/organization & administration , Community Networks/standards , Community Networks/trends , Coronavirus Infections/blood , Coronavirus Infections/epidemiology , Disease Outbreaks , France/epidemiology , History, 21st Century , Humans , Intersectoral Collaboration , Pandemics , Pneumonia, Viral/blood , Pneumonia, Viral/epidemiology , Professional Practice/organization & administration , Professional Practice/standards , Professional Practice/trends , Societies, Scientific/standards , Videoconferencing/organization & administration , Videoconferencing/standards
10.
Ann Biol Clin (Paris) ; 78(3): 269-277, 2020 Jun 01.
Article in English | MEDLINE | ID: covidwho-600996

ABSTRACT

The SARS-CoV-2 virus is responsible for an epidemic disease called COVID-19, which was initially evidenced in Wuhan, China, and spread very rapidly in China and around the world. In France, the first isolated case seems now to be reported in December 2019, stage 3 of the COVID-19 epidemic was triggered on March 14th, the start of the planned containment exit from May 11th. Healthcare services have faced a large influx of patients who may be beyond their capacity to receive and care, particularly in the Large-East and Ile-de-France regions. Some patients show an evolution of the disease never observed before with other coronaviruses and develop in a few days a very important inflammatory reaction, which can lead to death of patients. A working group of the French Society of Clinical Biology (SFBC) was set up with the objective of providing updated information on the current status of the biological prescriptions (focusing on biochemistry ones) and their evolution during the epidemic, and of analyzing the biological parameters associated with comorbidities and patient evolution in order to link biological results with medical events. The expanded working group covers all sectors of medical biology in France and extends to the French-speaking world: hospital sectors (CHU and CH, Army Training Hospitals) and the private sector opening a field of view on the biological situation in establishments for dependent elderly, social establishments and clinical medical institutions. The purpose of this article is the presentation of this working group and its immediate and future actions.


Subject(s)
Betacoronavirus , Biochemistry/organization & administration , Biomarkers/analysis , Clinical Laboratory Services/organization & administration , Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , Societies, Scientific/organization & administration , Betacoronavirus/isolation & purification , Betacoronavirus/pathogenicity , Biochemistry/standards , Biomarkers/blood , Clinical Laboratory Services/standards , Community Networks/organization & administration , Community Networks/standards , Community Networks/trends , Coronavirus Infections/blood , Coronavirus Infections/epidemiology , Disease Outbreaks , France/epidemiology , History, 21st Century , Humans , Intersectoral Collaboration , Pandemics , Pneumonia, Viral/blood , Pneumonia, Viral/epidemiology , Professional Practice/organization & administration , Professional Practice/standards , Professional Practice/trends , Societies, Scientific/standards , Videoconferencing/organization & administration , Videoconferencing/standards
11.
J Am Soc Cytopathol ; 9(3): 202-211, 2020.
Article in English | MEDLINE | ID: covidwho-15970

ABSTRACT

The coronavirus disease 2019 (COVID-19) is a pandemic caused by the SARS-CoV-2 virus. The infection has predominantly respiratory transmission and is transmitted through large droplets or aerosols, and less commonly by contact with infected surfaces or fomites. The alarming spread of the infection and the severe clinical disease that it may cause have led to the widespread institution of social distancing measures. Because of repeated exposure to potentially infectious patients and specimens, health care and laboratory personnel are particularly susceptible to contract COVID-19. This review paper provides an assessment of the current state of knowledge about the disease and its pathology, and the potential presence of the virus in cytology specimens. It also discusses the measures that cytology laboratories can take to function during the pandemic, and minimize the risk to their personnel, trainees, and pathologists. In addition, it explores potential means to continue to educate trainees during the COVID-19 pandemic.


Subject(s)
Cell Biology/trends , Clinical Laboratory Services/standards , Coronavirus Infections/pathology , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/pathology , Pneumonia, Viral/prevention & control , Specimen Handling/standards , Betacoronavirus/pathogenicity , Clinical Laboratory Services/trends , Containment of Biohazards/standards , Coronavirus Infections/transmission , Coronavirus Infections/virology , Humans , Pneumonia, Viral/transmission , Pneumonia, Viral/virology , Safety , Specimen Handling/trends
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