Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 161
Filter
Add filters

Year range
1.
Eur Rev Med Pharmacol Sci ; 25(1): 503-517, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-1052577

ABSTRACT

OBJECTIVE: To evaluate the diagnostic accuracy of the Food and Drug Administration Emergency Use Authorization (FDA-EUA) authorized point-of-care tests (POCTs) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MATERIALS AND METHODS: A systematic literature search was conducted using the PubMed, Embase, and Web of Science databases for articles published till August 10, 2020. We included studies providing information regarding diagnostic test accuracy of FDA-EUA POCTs for SARS-CoV-2 detection. The methodologic quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. The review protocol is registered in the International Prospective Register of Systematic Reviews (protocol number CRD42020202248). RESULTS: We included 26 studies describing a total of 3242 samples. The summary sensitivity and specificity were 0.94 [95% confidence interval (CI): 0.88-0.97] and 1.00 (95% CI: 0.99-1.00), respectively. The area under the summary receiver operating characteristic curve was 1.00 (95% CI: 0.99-1.00). A pooled analysis based on the index test revealed a summary sensitivity and specificity of Cepheid Xpert Xpress SARS-CoV-2 [0.99 (95% CI: 0.97-1.00) and 0.99 (95% CI: 0.94-1.00, respectively)] and ID NOW COVID-19 [0.78 (95% CI: 0.74-0.82) and 1.00 (95% CI: 0.98-1.00), respectively]. CONCLUSIONS: FDA-EUA POCTs, especially molecular assays, have high sensitivity, specificity, and overall diagnostic accuracy for detecting SARS-CoV-2. If approved, FDA-EUA POCTs can provide a rapid and practical way to identify infected individuals early on and help to limit the strain on the healthcare system. However, more high-quality clinical data are required to support our results.


Subject(s)
/methods , /diagnosis , Point-of-Care Testing/standards , /isolation & purification , Clinical Laboratory Techniques/methods , Clinical Laboratory Techniques/standards , Humans , Quality Assurance, Health Care , Sensitivity and Specificity , United States , United States Food and Drug Administration
3.
CMAJ Open ; 8(4): E887-E894, 2020.
Article in English | MEDLINE | ID: covidwho-1000597

ABSTRACT

BACKGROUND: The prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among asymptomatic patients admitted to hospital has implications for personal protective equipment use, testing strategy and confidence in the safety of acute care services. Our aim was to estimate the positivity rate of reverse transcription polymerase chain reaction (RT-PCR) testing among people admitted to hospital without symptoms of coronavirus disease 2019 (COVID-19) in Alberta, Canada. METHODS: Between Apr. 9 and May 24, 2020, we screened for COVID-19 symptoms and tested for SARS-CoV-2 infection in all consecutive adult patients (≥ 18 yr) admitted via emergency department to 3 Alberta hospitals. We summarized the parameters of the epidemic curve and assessed the performance of symptom screening versus RT-PCR results on nasopharyngeal or oropharyngeal swab samples. RESULTS: The study period encompassed Alberta's initial epidemic curve, with peak active cases per 100 000 of 71.4 (0.07%) on Apr. 30, 2020, and 14.7 and 14.6 at the beginning (Apr. 9, 2020) and end (May 24, 2020), respectively. Testing for SARS-CoV-2 infection (64.9% throat and 35.1% nasopharyngeal swabs) was done on 3375 adults (mean age 51, standard deviation 21, yr; 51.5% men). None of the asymptomatic patients (n = 1814) tested positive, and 71 of those with symptoms tested positive (n = 1561; 4.5%, 95% confidence interval [CI] 3.6%-5.7%). Sensitivity of symptom screening (v. RT-PCR) was 100% (95% CI 95%-100%), and specificity was 55% (95% CI 53%-57%). Posttest probabilities for prevalence of SARS-CoV-2 infection ranging from 1.5 to 14 times the peak prevalence of active cases during the study did not change when we assumed lower sensitivity (92%). INTERPRETATION: In a region with low disease prevalence where protocolized symptom assessment was in place during the admission process, we did not identify people admitted to hospital without COVID-19 symptoms who were RT-PCR positive. There may not be additive benefit to universal testing of asymptomatic patients on hospital admission in a setting of low pretest probability and strong public health containment.


Subject(s)
Asymptomatic Diseases/epidemiology , Clinical Laboratory Techniques/standards , Emergency Service, Hospital/statistics & numerical data , Mass Screening/methods , Quality Improvement , Alberta/epidemiology , Comorbidity , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies
4.
Eur Rev Med Pharmacol Sci ; 24(21): 11445-11454, 2020 Nov.
Article in English | MEDLINE | ID: covidwho-937852

ABSTRACT

In Italy, SARS-CoV-2 outbreak registered a high transmission and disease rates. During the acute phase, oncologists provided to re-organize services and prioritize treatments, in order to limit viral spread and to protect cancer patients. The progressive reduction of the number of infections has prompted Italian government to gradually loosen the national confinement measures and to start the "Second phase" of measures to contain the pandemic. The issue on how to organize cancer care during this post-acute SARS-CoV-2 phase appears crucial and a reassessment of healthcare services is needed requiring new models of care for oncological patients. In order to address major challenges in cancer setting during post-acute SARS-CoV-2 phase, this work offers multidimensional solutions aimed to provide a new way to take care of cancer patients.


Subject(s)
Communicable Disease Control/organization & administration , Coronavirus Infections/prevention & control , Medical Oncology/organization & administration , Models, Organizational , Neoplasms/therapy , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Betacoronavirus/pathogenicity , Clinical Laboratory Techniques/standards , Communicable Disease Control/standards , Coronavirus Infections/diagnosis , Coronavirus Infections/epidemiology , Coronavirus Infections/transmission , Home Care Services, Hospital-Based/organization & administration , Home Care Services, Hospital-Based/standards , Humans , Italy/epidemiology , Medical Oncology/standards , Neoplasms/diagnosis , Pneumonia, Viral/diagnosis , Pneumonia, Viral/epidemiology , Pneumonia, Viral/transmission , Triage/organization & administration , Triage/standards
6.
World J Gastroenterol ; 26(40): 6270-6278, 2020 Oct 28.
Article in English | MEDLINE | ID: covidwho-921239

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, mostly causing respiratory symptoms, is also known to affect the gastrointestinal tract. Several case reports hypothesize that SARS-CoV-2 could be an etiological factor in acute pancreatitis (AP). AIM: To assess all the available evidence in the literature relating to coronavirus disease 2019 (COVID-19) and AP. METHODS: We performed a systematic review of the available literature on the topic. The systematic search was conducted on 15 May 2020 on MEDLINE, EMBASE, CENTRAL, Web of Science and Scopus with a search key using the terms "amylase," "lipase," "pancr*," "COVID-19" and synonyms. Due to the low quality and poor comparability of the studies, a meta-analysis was not performed. RESULTS: Six case reports and two retrospective cohorts were included, containing data on eleven COVID-19 patients with AP. Five patients had AP according to the Atlanta classification. Other publications did not provide sufficient information on the diagnostic criteria. Most cases were considered SARS-CoV-2-induced, while several established etiological factors were not investigated. We were able to identify other possible causes in most of them. CONCLUSION: We strongly highlight the need for adherence to the guidelines during a diagnostic and etiological workup, which could alter therapy.


Subject(s)
Betacoronavirus/isolation & purification , Clinical Laboratory Techniques/methods , Coronavirus Infections/diagnosis , Pancreatitis/virology , Pneumonia, Viral/diagnosis , Acute Disease , Clinical Laboratory Techniques/standards , Coronavirus Infections/complications , Guideline Adherence , Humans , Pandemics , Pneumonia, Viral/complications , Practice Guidelines as Topic
7.
BMJ ; 371: m4262, 2020 11 11.
Article in English | MEDLINE | ID: covidwho-919183

ABSTRACT

OBJECTIVE: To assess the accuracy of the AbC-19 Rapid Test lateral flow immunoassay for the detection of previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. DESIGN: Test accuracy study. SETTING: Laboratory based evaluation. PARTICIPANTS: 2847 key workers (healthcare staff, fire and rescue officers, and police officers) in England in June 2020 (268 with a previous polymerase chain reaction (PCR) positive result (median 63 days previously), 2579 with unknown previous infection status); and 1995 pre-pandemic blood donors. MAIN OUTCOME MEASURES: AbC-19 sensitivity and specificity, estimated using known negative (pre-pandemic) and known positive (PCR confirmed) samples as reference standards and secondly using the Roche Elecsys anti-nucleoprotein assay, a highly sensitive laboratory immunoassay, as a reference standard in samples from key workers. RESULTS: Test result bands were often weak, with positive/negative discordance by three trained laboratory staff for 3.9% of devices. Using consensus readings, for known positive and negative samples sensitivity was 92.5% (95% confidence interval 88.8% to 95.1%) and specificity was 97.9% (97.2% to 98.4%). Using an immunoassay reference standard, sensitivity was 94.2% (90.7% to 96.5%) among PCR confirmed cases but 84.7% (80.6% to 88.1%) among other people with antibodies. This is consistent with AbC-19 being more sensitive when antibody concentrations are higher, as people with PCR confirmation tended to have more severe disease whereas only 62% (218/354) of seropositive participants had had symptoms. If 1 million key workers were tested with AbC-19 and 10% had actually been previously infected, 84 700 true positive and 18 900 false positive results would be projected. The probability that a positive result was correct would be 81.7% (76.8% to 85.8%). CONCLUSIONS: AbC-19 sensitivity was lower among unselected populations than among PCR confirmed cases of SARS-CoV-2, highlighting the scope for overestimation of assay performance in studies involving only PCR confirmed cases, owing to "spectrum bias." Assuming that 10% of the tested population have had SARS-CoV-2 infection, around one in five key workers testing positive with AbC-19 would be false positives. STUDY REGISTRATION: ISRCTN 56609224.


Subject(s)
Clinical Laboratory Techniques/standards , Coronavirus Infections/diagnosis , Immunoassay/standards , Pneumonia, Viral/diagnosis , Betacoronavirus , Female , Firefighters , Health Personnel , Humans , Male , Pandemics , Police , Predictive Value of Tests , Reagent Kits, Diagnostic/standards , Sensitivity and Specificity , United Kingdom
10.
Genes (Basel) ; 11(10)2020 10 12.
Article in English | MEDLINE | ID: covidwho-905037

ABSTRACT

WHO declared the novel coronavirus (COVID-19) outbreak a global pandemic on 11 March 2020. The establishment of standardized RT-qPCR protocols for respiratory secretions testing, as well as sharing of specimens, data, and information became critical. Here, we investigate the analytical performance of two interim RT-qPCR protocols (Charité and Centers for Disease Control (CDC)) for the qualitative detection of SARS-CoV-2 executed in a fully automated platform. Analytical specificity, PCR amplification efficiency, analytical sensitivity (limit of detection), and cross-reactivity were evaluated using contrived samples. The on-going accuracy was evaluated by retrospective analysis of our test results database (real clinical samples). N1, E, and a modified version of RdRP assays presented adequate analytical specificity, amplification efficiency, and analytical sensitivity using contrived samples. The three assays were applied to all individuals who requested the SARS-CoV-2 molecular test assay in our laboratory and it was observed that N1 gave more positive results than E, and E gave more positive results than RdRP (modified). The RdRP and E were removed from the test and its final version, based on N1 assay only, was applied to 30,699 Brazilian individuals (from 19 February 2020 to 8 May 2020). The aggregated test results available in the database were also presented.


Subject(s)
Automation, Laboratory/standards , Clinical Laboratory Techniques/standards , Real-Time Polymerase Chain Reaction/standards , Reverse Transcriptase Polymerase Chain Reaction/standards , Automation, Laboratory/methods , Clinical Laboratory Techniques/methods , Coronavirus Infections/diagnosis , Humans , Limit of Detection , Real-Time Polymerase Chain Reaction/methods , Reproducibility of Results , Reverse Transcriptase Polymerase Chain Reaction/methods
11.
PLoS Biol ; 18(10): e3000867, 2020 10.
Article in English | MEDLINE | ID: covidwho-901993

ABSTRACT

The current quantitative reverse transcription PCR (RT-qPCR) assay recommended for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing in the United States requires analysis of 3 genomic targets per sample: 2 viral and 1 host. To simplify testing and reduce the volume of required reagents, we devised a multiplex RT-qPCR assay to detect SARS-CoV-2 in a single reaction. We used existing N1, N2, and RP primer and probe sets by the Centers for Disease Control and Prevention, but substituted fluorophores to allow multiplexing of the assay. The cycle threshold (Ct) values of our multiplex RT-qPCR were comparable to those obtained by the single assay adapted for research purposes. Low copy numbers (≥500 copies/reaction) of SARS-CoV-2 RNA were consistently detected by the multiplex RT-qPCR. Our novel multiplex RT-qPCR improves upon current single diagnostics by saving reagents, costs, time, and labor.


Subject(s)
Betacoronavirus/genetics , Clinical Laboratory Techniques/methods , Coronavirus Infections/diagnosis , Multiplex Polymerase Chain Reaction/standards , Pneumonia, Viral/diagnosis , RNA, Viral/genetics , Reagent Kits, Diagnostic/standards , Reverse Transcriptase Polymerase Chain Reaction/standards , Betacoronavirus/pathogenicity , Case-Control Studies , Clinical Laboratory Techniques/standards , Coronavirus Infections/virology , DNA Primers/standards , HEK293 Cells , Humans , Limit of Detection , Nasopharynx/virology , Pandemics , Pneumonia, Viral/virology , United States
15.
Sci Rep ; 10(1): 18764, 2020 10 30.
Article in English | MEDLINE | ID: covidwho-894422

ABSTRACT

Droplet digital PCR (ddPCR) is a sensitive and reproducible technology widely used for quantitation of several viruses. The aim of this study was to evaluate the 2019-nCoV CDC ddPCR Triplex Probe Assay (BioRad) performance, comparing the direct quantitation of SARS-CoV-2 on nasopharyngeal swab with the procedure applied to the extracted RNA. Moreover, two widely used swab types were compared (UTM 3 mL and ESwab 1 mL, COPAN). A total of 50 nasopharyngeal swabs (n = 25 UTM 3 mL and n = 25 ESwab 1 mL) from SARS-CoV-2 patients, collected during the pandemic at IRCCS Sacro Cuore Don Calabria Hospital (Veneto Region, North-East Italy), were used for our purpose. After heat inactivation, an aliquot of swab medium was used for the direct quantitation. Then, we compared the direct method with the quantitation performed on the RNA purified from nasopharyngeal swab by automated extraction. We observed that the direct approach achieved generally equal RNA copies compared to the extracted RNA. The results with the direct quantitation were more accurate on ESwab with a sensitivity of 93.33% [95% CI, 68.05 to 99.83] and specificity of 100.00% for both N1 and N2. On the other hand, on UTM we observed a higher rate of discordant results for N1 and N2. The human internal amplification control (RPP30) showed 100% of both sensitivity and specificity independent of swabs and approaches. In conclusion, we described a direct quantitation of SARS-CoV-2 in nasopharyngeal swab. Our approach resulted in an efficient quantitation, without automated RNA extraction and purification. However, special care needs to be taken on the potential bias due to the conservation of samples and to the heating treatment, as we used thawed and heat inactivated material. Further studies on a larger cohort of samples are warranted to evaluate the clinical value of this direct approach.


Subject(s)
Clinical Laboratory Techniques/methods , Multiplex Polymerase Chain Reaction/methods , Betacoronavirus/genetics , Betacoronavirus/pathogenicity , Clinical Laboratory Techniques/standards , Coronavirus Infections/diagnosis , Humans , Limit of Detection , Multiplex Polymerase Chain Reaction/standards , Reproducibility of Results , Respiratory Mucosa/virology
16.
J Crohns Colitis ; 14(Supplement_3): S791-S797, 2020 Oct 21.
Article in English | MEDLINE | ID: covidwho-883090

ABSTRACT

Endoscopy is an essential component in the management of inflammatory bowel disease [IBD]. There is a risk of SARS-CoV-2 transmission during endoscopic procedures. The International Organization for the study of IBD [IOIBD] has developed 11 position statements, based on an online survey, that focus on how to prioritise endoscopies in IBD patients during the COVID-19 pandemic, alternative modes for disease monitoring, and ways to triage the high number of postponed endoscopies after the pandemic. We propose to pre-screen patients for suspected or confirmed COVID-19 and test for SARS-CoV-2 before endoscopy if available. High priority endoscopies during pandemic include acute gastrointestinal bleed, acute severe ulcerative colitis, new IBD diagnosis, cholangitis in primary sclerosing cholangitis, and partial bowel obstruction. Alternative modes of monitoring using clinical symptoms, serum inflammatory markers, and faecal calprotectin should be considered during the pandemic. Prioritising access to endoscopy in the post-pandemic period should be guided by control of COVID-19 in the local community and availability of manpower and personal protective equipment. Endoscopy should be considered within 3 months after the pandemic for patients with a past history of dysplasia and endoscopic resection for dysplastic lesion. Endoscopy should be considered 3-6 months after the pandemic for assessment of postoperative recurrence or new biologic initiation. Endoscopy can be postponed until after 6 months of pandemic for routine IBD surveillance and assessment of mucosal healing.


Subject(s)
Betacoronavirus , Coronavirus Infections/prevention & control , Endoscopy, Gastrointestinal/standards , Health Care Rationing/standards , Infection Control/standards , Inflammatory Bowel Diseases/diagnostic imaging , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Triage/standards , Clinical Laboratory Techniques/standards , Coronavirus Infections/complications , Coronavirus Infections/diagnosis , Endoscopy, Gastrointestinal/methods , Global Health , Health Care Rationing/methods , Health Services Accessibility/standards , Humans , Infection Control/methods , Inflammatory Bowel Diseases/complications , Pneumonia, Viral/complications , Pneumonia, Viral/diagnosis , Triage/methods
19.
PLoS One ; 15(10): e0240783, 2020.
Article in English | MEDLINE | ID: covidwho-874204

ABSTRACT

BACKGROUND: Understanding and monitoring the demographics of SARS-CoV-2 infection can inform strategies for prevention. Surveillance monitoring has suggested that the age distribution of people infected with SARS-CoV-2 has changed since the pandemic began, but no formal analysis has been performed. METHODS: Retrospective review of SARS-CoV-2 molecular testing results from a national reference laboratory was performed. Result distributions by age and positivity were compared between early period (March-April 2020) and late periods (June-July 2020) of the COVID-19 pandemic. Additionally, a sub-analysis compared changing age distributions between inpatients and outpatients. RESULTS: There were 277,601 test results of which 19320 (7.0%) were positive. The median age of infected people declined over time (p < 0.0005). In March-April, the median age of positive people was 40.8 years (Interquartile range (IQR): 29.0-54.1). In June-July, the median age of positive people was 35.8 years (IQR: 24.0-50.2). The positivity rate of patients under 50 increased from 6.0 to 10.6 percent and the positivity rate for those over 50 decreased from 6.3 to 5.0 percent between the early and late periods. The trend was only observed for outpatient populations. CONCLUSIONS: We confirm that there is a trend toward decreasing age among persons with laboratory-confirmed SARS-CoV-2 infection, but that these trends seem to be specific to the outpatient population. Overall, this suggests that observed age-related trends are driven by changes in testing patterns rather than true changes in the epidemiology of SARS-CoV-2 infection. This calls for caution in interpretation of routine surveillance data until testing patterns stabilize.


Subject(s)
Clinical Laboratory Techniques/statistics & numerical data , Coronavirus Infections/epidemiology , Epidemiological Monitoring , Pneumonia, Viral/epidemiology , Adolescent , Adult , Age Distribution , Aged , Aged, 80 and over , Child , Child, Preschool , Clinical Laboratory Techniques/standards , Coronavirus Infections/diagnosis , Humans , Infant , Middle Aged , Pandemics , United States
20.
PLoS One ; 15(10): e0240779, 2020.
Article in English | MEDLINE | ID: covidwho-874201

ABSTRACT

The practicability of a prototype capillary whole-blood IgG-IgM COVID-19 self-test (Exacto® COVID-19 self-test, Biosynex Swiss SA, Freiburg, Switzerland) as a serological screening tool for SARS-CoV-2 infection adapted to the general public was evaluated in a cross-sectional, general adult population study performed between April and May 2020 in Strasbourg, France, consisting of face-to-face, paper-based, semi-structured, and self-administrated questionnaires. Practicability was defined as the correct use of the self-test and the correct interpretation of the result. The correct use of self-test was conditioned by the presence of the control band after 15-min of migration. The correct interpretation of the tests was defined by the percent agreement between the tests results read and interpret by the participants compared to the expected results coded by the numbers and verified by trained observers. A total of 167 participants (52.7% female; median age, 35.8 years; 82% with post-graduate level) were enrolled, including 83 and 84 for usability and test results interpretation substudies, respectively. All participants (100%; 95% CI: 95.6-100) correctly used the self-test. However, 12 (14.5%; 95% CI: 8.5-23.6) asked for verbal help. The percent agreement between the tests results read and interpret by the participants compared to the expected results was 98.5% (95% CI: 96.5-99.4). However, misinterpretation occurred in only 2.3% of positive and 1.2% of invalid test results. Finally, all (100%) participants found that performing the COVID-19 self-test was easy; and 98.8% found the interpretation of the self-test results easy. Taken together, these pilot observations demonstrated for the first-time, high practicability and satisfaction of COVID-19 self-testing for serological IgG and IgM immune status, indicating its potential for use by the general public to complete the arsenal of available SARS-CoV-2 serological assays in the urgent context of the COVID-19 epidemic.


Subject(s)
Clinical Laboratory Techniques/methods , Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , Reagent Kits, Diagnostic/standards , Adult , Clinical Laboratory Techniques/standards , Coronavirus Infections/blood , Female , Humans , Immunoglobulin G/blood , Immunoglobulin M/blood , Male , Mass Screening/methods , Mass Screening/standards , Pandemics , Pneumonia, Viral/blood , Point-of-Care Testing , Self Administration , Sensitivity and Specificity
SELECTION OF CITATIONS
SEARCH DETAIL