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1.
Parasitol Res ; 121(7): 1867-1885, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-2174153

ABSTRACT

Malaria control measures have been in use for years but have not completely curbed the spread of infection. Ultimately, global elimination is the goal. A major playmaker in the various approaches to reaching the goal is the issue of proper diagnosis. Various diagnostic techniques were adopted in different regions and geographical locations over the decades, and these have invariably produced diverse outcomes. In this review, we looked at the various approaches used in malaria diagnostics with a focus on methods favorably used during pre-elimination and elimination phases as well as in endemic regions. Microscopy, rapid diagnostic testing (RDT), loop-mediated isothermal amplification (LAMP), and polymerase chain reaction (PCR) are common methods applied depending on prevailing factors, each with its strengths and limitations. As the drive toward the elimination goal intensifies, the search for ideal, simple, fast, and reliable point-of-care diagnostic tools is needed more than ever before to be used in conjunction with a functional surveillance system supported by the ideal vaccine.


Subject(s)
Malaria, Falciparum , Malaria , Diagnostic Tests, Routine/methods , Goals , Humans , Malaria/diagnosis , Malaria/prevention & control , Malaria, Falciparum/epidemiology , Microscopy/methods , Molecular Diagnostic Techniques/methods , Nucleic Acid Amplification Techniques/methods , Polymerase Chain Reaction/methods , Sensitivity and Specificity
2.
JMIR Public Health Surveill ; 8(1): e30006, 2022 01 06.
Article in English | MEDLINE | ID: covidwho-2197939

ABSTRACT

BACKGROUND: A description of individuals with SARS-CoV-2 infection comparing the first and second waves could help adapt health services to manage this highly transmissible infection. OBJECTIVE: We aimed to describe the epidemiology of individuals with suspected SARS-CoV-2 infection, and the characteristics of patients with a positive test comparing the first and second waves in Catalonia, Spain. METHODS: This study had 2 stages. First, we analyzed daily updated data on SARS-CoV-2 infection in individuals from Girona (Catalonia). Second, we compared 2 retrospective cohorts of patients with a positive reverse-transcription polymerase chain reaction or rapid antigen test for SARS-CoV-2. The severity of patients with a positive test was defined by their admission to hospital, admission to intermediate respiratory care, admission to the intensive care unit, or death. The first wave was from March 1, 2020, to June 24, 2020, and the second wave was from June 25, 2020, to December 8, 2020. RESULTS: The numbers of tests and cases were lower in the first wave than in the second wave (26,096 tests and 3140 cases in the first wave versus 140,332 tests and 11,800 cases in the second wave), but the percentage of positive results was higher in the first wave than in the second wave (12.0% versus 8.4%). Among individuals with a positive diagnostic test, 818 needed hospitalization in the first wave and 680 in the second; however, the percentage of hospitalized individuals was higher in the first wave than in the second wave (26.1% versus 5.8%). The group that was not admitted to hospital included older people and those with a higher percentage of comorbidities in the first wave, whereas the characteristics of the groups admitted to hospital were more alike. CONCLUSIONS: Screening systems for SARS-CoV-2 infection were scarce during the first wave, but were more adequate during the second wave, reflecting the usefulness of surveillance systems to detect a high number of asymptomatic infected individuals and their contacts, to help control this pandemic. The characteristics of individuals with SARS-CoV-2 infection in the first and second waves differed substantially; individuals in the first wave were older and had a worse health condition.


Subject(s)
COVID-19 , Aged , Diagnostic Tests, Routine , Humans , Retrospective Studies , SARS-CoV-2 , Spain/epidemiology
3.
JMIR Public Health Surveill ; 7(6): e29528, 2021 06 10.
Article in English | MEDLINE | ID: covidwho-2197929

ABSTRACT

BACKGROUND: COVID-19 testing remains an essential element of a comprehensive strategy for community mitigation. Social media is a popular source of information about health, including COVID-19 and testing information. One of the most popular communication channels used by adolescents and young adults who search for health information is TikTok-an emerging social media platform. OBJECTIVE: The purpose of this study was to describe TikTok videos related to COVID-19 testing. METHODS: The hashtag #covidtesting was searched, and the first 100 videos were included in the study sample. At the time the sample was drawn, these 100 videos garnered more than 50% of the views for all videos cataloged under the hashtag #covidtesting. The content characteristics that were coded included mentions, displays, or suggestions of anxiety, COVID-19 symptoms, quarantine, types of tests, results of test, and disgust/unpleasantness. Additional data that were coded included the number and percentage of views, likes, and comments and the use of music, dance, and humor. RESULTS: The 100 videos garnered more than 103 million views; 111,000 comments; and over 12.8 million likes. Even though only 44 videos mentioned or suggested disgust/unpleasantness and 44 mentioned or suggested anxiety, those that portrayed tests as disgusting/unpleasant garnered over 70% of the total cumulative number of views (73,479,400/103,071,900, 71.29%) and likes (9,354,691/12,872,505, 72.67%), and those that mentioned or suggested anxiety attracted about 60% of the total cumulative number of views (61,423,500/103,071,900, 59.59%) and more than 8 million likes (8,339,598/12,872,505, 64.79%). Independent one-tailed t tests (α=.05) revealed that videos that mentioned or suggested that COVID-19 testing was disgusting/unpleasant were associated with receiving a higher number of views and likes. CONCLUSIONS: Our finding of an association between TikTok videos that mentioned or suggested that COVID-19 tests were disgusting/unpleasant and these videos' propensity to garner views and likes is of concern. There is a need for public health agencies to recognize and address connotations of COVID-19 testing on social media.


Subject(s)
COVID-19/diagnosis , Diagnostic Tests, Routine , Social Media , Adolescent , Community Networks , Humans , SARS-CoV-2 , Video Recording , Young Adult
4.
PLoS One ; 17(11): e0263549, 2022.
Article in English | MEDLINE | ID: covidwho-2119319

ABSTRACT

Since the COVID-19 pandemic there has been a rapid uptake and utilisation of telemedicine in all aspects of healthcare. This presents a key opportunity in surgical site infection surveillance. Remote follow up methods have been used via telephone, with photographs and questionnaires for post-operative reviews with varying results. This review therefore aims to comprehensively synthesise available evidence for the diagnostic accuracy of all forms of SSI telemedicine monitoring. The protocol has been established as per both PRISMA-P (S1 Table) and the Cochrane handbook for reviews of diagnostic test accuracy. Medline, Embase, CENTRAL and CINAHL will be searched using a complete search strategy developed with librarian input, in addition to google scholar and hand searching. All study designs with patients over 18 and undergone a primarily closed surgical procedure will be eligible. Index tests will include all forms of telemedicine and a subgroup analysis performed for each of these. Comparative tests must include face to face review, and all reference standards will be included again for sub-group analyses. Search results will be screened by two investigators independently with a third providing consensus review on disagreements. Methodological quality will be assessed using the QUADAS-2 tool, first validated by two investigators as per the Cochrane handbook. Exploratory analysis will formulate summary receiver operating characteristic curves and forest plots with estimates of sensitivity and specificity of the included studies. Sources of heterogeneity will be identifying and investigated through further analysis. Potential benefits of telemedicine integration in surgical practice will reduce cost and travel time to patients in addition to avoiding wasted clinic appointments, important considerations in a peri-pandemic era. To avoid missed or further complications, there must be confidence in the ability to diagnose infection. This review will systematically determine whether telemedicine is accurate for surgical site infection diagnosis, which methods are well established and if further research is indicated.


Subject(s)
COVID-19 , Telemedicine , Humans , Surgical Wound Infection/diagnosis , Diagnostic Tests, Routine , Pandemics , COVID-19/diagnosis , Systematic Reviews as Topic , Meta-Analysis as Topic , Telemedicine/methods , Review Literature as Topic
5.
J Korean Med Sci ; 37(43): e310, 2022 Nov 07.
Article in English | MEDLINE | ID: covidwho-2109726

ABSTRACT

Antigen rapid diagnostic tests (RDTs) became the most important tool for the diagnosis of the coronavirus disease 2019 (COVID-19), however there have been very few evaluations of the accuracy of the RDTs in actual use. In this study, we investigated the performance accuracy of the RDT, the STANDARD Q COVID-19 Ag (STANDARD Q), in the Republic of Korea. We collected a total of 5,792 results that underwent both RDT and reverse transcription polymerase chain reaction simultaneously, and overall sensitivity and specificity of the STANDARD Q were 57.6% and 99.9%, respectively. With binomial logistic regression analysis, we estimated that about half of the COVID-19 patients with a cycle threshold value of 25 for E and RdRP were RDT-negative. These results suggest that the clinical sensitivity of RDTs against severe acute respiratory syndrome coronavirus 2 is considerably low in a real-world setting, and we recommend that limitations of RDTs should be considered when setting up COVID-19 test strategies.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , COVID-19/diagnosis , Diagnostic Tests, Routine , Sensitivity and Specificity , Republic of Korea , Antigens, Viral
6.
Biosensors (Basel) ; 12(11)2022 Nov 07.
Article in English | MEDLINE | ID: covidwho-2099353

ABSTRACT

The COVID-19 pandemic caused by SARS-CoV-2 has drawn attention to the need for fast and accurate diagnostic testing. Concerns from emerging SARS-CoV-2 variants and other circulating respiratory viral pathogens further underscore the importance of expanding diagnostic testing to multiplex detection, as single-plex diagnostic testing may fail to detect emerging variants and other viruses, while sequencing can be too slow and too expensive as a diagnostic tool. As a result, there have been significant advances in multiplex nucleic-acid-based virus diagnostic testing, creating a need for a timely review. This review first introduces frequent nucleic acid targets for multiplex virus diagnostic tests, then proceeds to a comprehensive and up-to-date overview of multiplex assays that incorporate various detection reactions and readout modalities. The performances, advantages, and disadvantages of these assays are discussed, followed by highlights of platforms that are amenable for point-of-care use. Finally, this review points out the remaining technical challenges and shares perspectives on future research and development. By examining the state of the art and synthesizing existing development in multiplex nucleic acid diagnostic tests, this review can provide a useful resource for facilitating future research and ultimately combating COVID-19.


Subject(s)
COVID-19 , Nucleic Acids , Humans , SARS-CoV-2 , COVID-19/diagnosis , Pandemics , Diagnostic Tests, Routine , Nucleic Acid Amplification Techniques , Sensitivity and Specificity
8.
Biotechniques ; 73(3): 136-141, 2022 09.
Article in English | MEDLINE | ID: covidwho-2022198

ABSTRACT

Mutations in the nucleocapsid of SARS-CoV-2 may interfere with antigen detection by diagnostic tests. We used several methods to evaluate the effect of various SARS-CoV-2 nucleocapsid mutations on the performance of the Panbio™ and BinaxNOW™ lateral flow rapid antigen tests and a prototype high-throughput immunoassay that utilizes Panbio antibodies. Variant detection was also evaluated by immunoblot and BIAcore™ assay. A panel of 23 recombinant nucleocapsid antigens (rAgs) were produced that included mutations found in circulating SARS-CoV-2 variants, including variants of concern. All mutant rAgs were detected by all assays, at a sensitivity equivalent to wild-type control (Wuhan strain). Thus, using a rAg approach, we found that the SARS-CoV-2 nucleocapsid mutations examined do not directly impact antigen detection or antigen assay performance.


Subject(s)
COVID-19 , SARS-CoV-2 , Antibodies, Viral , COVID-19/diagnosis , COVID-19/genetics , COVID-19 Testing , Diagnostic Tests, Routine , Humans , Mutation , Nucleocapsid/genetics , SARS-CoV-2/genetics , Sensitivity and Specificity
9.
BMJ Open ; 12(8): e057746, 2022 08 29.
Article in English | MEDLINE | ID: covidwho-2020034

ABSTRACT

INTRODUCTION: Increasing numbers of patients with non-haematological diseases are infected with invasive pulmonary aspergillosis (IPA), with a high mortality reported which is mainly due to delayed diagnosis. The diagnostic capability of mycological tests for IPA including galactomannan test, (1,3)-ß-D-glucan test, lateral flow assay, lateral flow device and PCR for the non-haematological patients remains unknown. This protocol aims to conduct a systematic review and meta-analysis of the diagnostic performance of mycological tests to facilitate the early diagnosis and treatments of IPA in non-haematological diseases. METHODS AND ANALYSIS: Database including PubMed, CENTRAL and EMBASE will be searched from 2002 until the publication of results. Cohort or cross-sectional studies that assessing the diagnostic capability of mycological tests for IPA in patients with non-haematological diseases will be included. The true-positive, false-positive, true-negative and false-negative of each test will be extracted and pooled in bivariate random-effects model, by which the sensitivity and specificity will be calculated with 95% CI. The second outcomes will include positive (negative) likelihood ratio, area under the receiver operating characteristic curve and diagnostic OR will also be computed in the bivariate model. When applicable, subgroup analysis will be performed with several prespecified covariates to explore potential sources of heterogeneity. Factors that may impact the diagnostic effects of mycological tests will be examined by sensitivity analysis. The risk of bias will be appraised by the Quality Assessment tool for Diagnostic Accuracy Studies (QUADAS-2). ETHICS AND DISSEMINATION: This protocol is not involved with ethics approval, and the results will be peer-reviewed and disseminated on a recognised journal. PROSPERO REGISTRATION NUMBER: CRD42021241820.


Subject(s)
Diagnostic Tests, Routine , Invasive Pulmonary Aspergillosis , Meta-Analysis as Topic , Systematic Reviews as Topic , Cross-Sectional Studies , Diagnostic Tests, Routine/standards , Hematology , Humans , Invasive Pulmonary Aspergillosis/diagnosis , Invasive Pulmonary Aspergillosis/microbiology , Likelihood Functions , Odds Ratio , ROC Curve , Sensitivity and Specificity , Systematic Reviews as Topic/methods
10.
Microbiol Spectr ; 10(5): e0122922, 2022 Oct 26.
Article in English | MEDLINE | ID: covidwho-2019781

ABSTRACT

Access to reverse transcription-PCR (RT-PCR) testing, the gold standard for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection, is limited throughout the world, due to restricted resources, available infrastructure, and high costs. Antigen-detecting rapid diagnostic tests (Ag-RDTs) overcome some of these barriers, but independent clinical validations in settings of intended use are scarce. To inform the World Health Organization's (WHO) emergency use listing (EUL) procedure and ensure affordable, high-quality Ag-RDTs, we assessed the performance and ease of use of the SureStatus for SARS-CoV-2. For this prospective, multicenter diagnostic accuracy study, we recruited unvaccinated participants with presumed SARS-CoV-2 infection in India and Germany from December 2020 to March 2021, when the Alpha (B.1.1.7) variant was predominantly circulating. Paired swabs were performed for (i) routine clinical RT-PCR testing (sampling was either nasopharyngeal [NP] or combined NP and oropharyngeal [NP/OP]) and (ii) Ag-RDT (sampling was NP). Performance of the Ag-RDT was compared to RT-PCR overall and by predefined subgroups, e.g., cycle threshold (CT) value, symptoms, and days from symptom onset. To understand the usability, a system usability scale (SUS) questionnaire and ease-of-use (EoU) assessment were performed. A total of 1,119 participants were included in the analysis, of whom 205 (18.3%) were RT-PCR positive. SureStatus detected 169 out of 205 RT-PCR-positive participants, reporting a sensitivity of 82.4% (95% confidence interval [CI]: 76.6% to 87.1%) and a specificity of 98.5% (95% CI: 97.4% to 99.1%). In the first 7 days post-symptom onset, the sensitivity was 90.7% (95% CI: 83.5% to 94.9%), when CT values were low and viral loads were high. The test was characterized as easy to use (SUS, 85/100) and considered suitable for point-of-care settings, although quality concerns were raised due to visibly contaminated packaging of swabs included in the test kits. The SureStatus diagnostic test can be considered a reliable test during the first week of SARS-CoV-2 infection, with high sensitivity in combination with excellent usability. IMPORTANCE Our manufacturer-independent, prospective diagnostic accuracy study assessed clinical performance in participants presumed to have a SARS-CoV-2 infection at three study sites in two countries. We assessed the accuracy overall and in predefined subgroups (CT values and symptom duration). SureStatus performed with high sensitivity. Its sensitivity was particularly high in the first 3 days after symptom onset and when CT values were low (i.e., the viral load was high). The system usability and ease-of-use assessment complements the accuracy assessment of the test and highlights critical factors to facilitate the widespread use of SureStatus in point-of-care settings. The high sensitivity demonstrated by the evaluated Ag-RDT within the first days of symptoms, when most transmission occurs, supports the role of Ag-RDTs for public health-relevant screening. Evidence from this study was used to inform the World Health Organization Emergency Use Listing procedure.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , SARS-CoV-2/genetics , COVID-19/diagnosis , Diagnostic Tests, Routine , Point-of-Care Systems , Prospective Studies , Sensitivity and Specificity , World Health Organization
11.
Virol J ; 19(1): 140, 2022 09 01.
Article in English | MEDLINE | ID: covidwho-2009431

ABSTRACT

BACKGROUND: Rapid and accurate detection of SARS-CoV-2 infection is the cornerstone of prompt patient care. However, the reliability of the antigen rapid diagnostic test (Ag-RDT) in the diagnosis of SARS-CoV-2 infection remains inconclusive. METHODS: We conducted a field evaluation of Ag-RDT performance during the Shanghai Coronavirus disease 2019 (COVID-19) quarantine and screened 7225 individuals visiting our Emergency Department. 83 asymptomatic SARS-CoV-2 (+) individuals were enrolled in the current study. Simultaneously, Ag-RDT was performed to evaluate its testing performance. RESULTS: For the Ag-RDT(-) cases, the average cycle threshold (Ct) values of the N gene were 27.26 ± 4.59, which were significantly higher than the Ct value (21.9 ± 4.73) of the Ag-RDT(+) individuals (p < 0.0001). The overall sensitivity of Ag-RDT versus that of RT-PCR was 43.37%. The Ag-RDT(+) individuals regarding the N gene's Ct value were 16 cases in the < 20 range, 12 in 20-25, 5 in 25-30, and 3 in 30-35. The corresponding sensitivity was 84.21%, 52.17%, 21.74% and 16.67%, respectively. Meanwhile, sampling had a straight specificity of 100% regardless of the Ct value. CONCLUSIONS: The Ag-RDT were extremely sensitive in asymptomatic COVID-19 individuals with a Ct value < 20.


Subject(s)
COVID-19 , Antigens, Viral/analysis , COVID-19/diagnosis , COVID-19 Testing , China/epidemiology , Diagnostic Tests, Routine , Humans , Primary Health Care , Quarantine , Reproducibility of Results , SARS-CoV-2/genetics , Sensitivity and Specificity
12.
Expert Rev Mol Diagn ; 22(1): 49-60, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-2008441

ABSTRACT

INTRODUCTION: Pneumonia is one of the main causes of mortality associated with infectious diseases worldwide. Several challenges have been identified in the management of patients with pneumonia, ranging from accurate and cost-effective microbiological investigations, prompt and adequate therapeutic management, and optimal treatment duration. AREAS COVERED: In this review, an updated summary on the current management of pneumonia patients is provided and the epidemiological issues of infectious respiratory diseases, which in the current pandemic situation are of particular concern, are addressed. The clinical and microbiological approaches to pneumonia diagnosis are reviewed, including discussion about the new molecular assays pointing out both their strengths and limitations. Finally, the current recommendations about antibiotic treatment are examined and discussed depending on the epidemiological contexts, including those with high prevalence of multidrug-resistant bacteria. EXPERT OPINION: We claim that rapid diagnostic tests, if well-positioned in the diagnostic workflow and reserved for the subset of patients who could most benefit from these technologies, may represent an interesting and feasible tool to optimize timing of targeted treatments especially in terms of early de-escalation or discontinuation of antibiotic therapy.


Subject(s)
Diagnostic Tests, Routine , Pneumonia , Anti-Bacterial Agents/therapeutic use , Drug Resistance, Multiple, Bacterial , Humans , Pneumonia/diagnosis , Pneumonia/drug therapy , Prevalence
13.
Wiad Lek ; 75(6): 1734-1740, 2022.
Article in English | MEDLINE | ID: covidwho-1994975

ABSTRACT

OBJECTIVE: The aim: To develop a quantitative tool to identify the cost and benefits of the appropriate and inappropriate laboratory tests. PATIENTS AND METHODS: Materials and methods: This is a retrospective study, conducted in Al Zahraa teaching hospital for children's health and maternity in a period between March 2021 to March 2022. We study the total laboratory investigation done in three years; before the COVID-19 era (1-3-2018 to 1-3-2019) and two consecutive years (1-3-2020 to 1-3-2021 and 1-3-2021 to 1-3-2022) to exclude the effect of COVID-19 pandemic on the results. And try to divide these test numbers according to each hospital department and the position of the test ordering doctor (senior or junior). We compare the total number of laboratory investigations with the total patient seeking medical care in Al Zahraa hospital, out or inpatient, i.e., ORDERING INDEX. Also, we calculate the (AVERAGE ORDERING INDEX) by dividing the number of all ordered tests by one specific test. RESULTS: Results: The total number of laboratory tests ordered in three (pre and peri COVID-19 pandemic) years show a significant increment in the last year (78249, 73600, and 1740249) respectively. Test ordering index, in the same way, shows significant increments over years (0.65, 0.64 Aand11.2) respectively. Biochemistry investigations constitute the largest proportion (50%) of all investigations that have been ordered last year. CBC is the most commonly ordered single test, in outpatient clinics, it is done 19510 times (Obstetrics and Gynecology 11850 vs Pediatric 7660). The positive (abnormal) results were only 4.8%. CONCLUSION: Conclusion: For more and more years, laboratory investigations have been overused. A large number of normal results indicate that the test order was chosen at random. The most commonly overused test is the complete blood count.


Subject(s)
COVID-19 , Diagnostic Tests, Routine , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19 Testing , Child , Cost-Benefit Analysis , Female , Hospitals, Teaching , Humans , Iraq , Pandemics , Pregnancy , Retrospective Studies
14.
Int J Surg ; 105: 106820, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-1983235

ABSTRACT

BACKGROUND: Corona 2 virus (SARS-CoV-2) is known as the causative agent of COVID-19 disease; the World Health Organization (WHO) declared it an epidemic on March 11, 2020. The Joint Guidelines of the Centers for Disease Control and Prevention (CDC) and the WHO including social distancing, the use of face masks, emphasis on hand washing, quarantine, and using diagnosis tests have been used widely, but the value of diagnostic interventions to prevent the transmission of SARS-CoV-2 is unclear. We compared the economic evaluation of different laboratory diagnostic interventions with each other and also with implementing the conservative CDC & WHO guidelines. MATERIAL AND METHODS: Electronic searches were conducted on PubMed, Embase, Science Direct, Scopus, Cochrane Library, Web of Knowledge, NHSEED, NHS Health Technology assessment (CRD), and Cost-Effectiveness Analysis Registry databases. Related articles were reviewed from January 2020 to the end of November 2021. RESULTS: Out of 1791 initial studies, 13 articles had the inclusion criteria. According to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist, ten studies were of excellent quality, and the remaining two studies were of very good quality. Most studies were cost-effectiveness analysis studies. The entered studies had different time horizons. Diagnostic tests reviewed in the studies included real-time polymerase chain reaction (RT-PCR) test, immunoglobulin G (IgG) & Antigen, point of care tests. Although polymerase chain reaction (PCR) testing improves the quality of life and survival for patients with infected Covid-19 based on its greater effectiveness compared to standard protection protocols, due to the high cost of this intervention, it has been considered a cost-effective method in some countries. CONCLUSION: Since most studies have been conducted in developed countries, it unquestionably does not make sense to extend these results to low-income and developing countries. Therefore further studies are required in low-income and developing countries to evaluate the cost-effectiveness of laboratory-based diagnostic methods (RT-PCR) of covid-19 in variable prevalence of infectious cases.


Subject(s)
COVID-19 , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Testing , Cost-Benefit Analysis , Diagnostic Tests, Routine , Humans , Immunoglobulin G , Quality of Life , SARS-CoV-2 , United States
15.
BMJ Open ; 12(7): e060985, 2022 Jul 19.
Article in English | MEDLINE | ID: covidwho-1950192

ABSTRACT

INTRODUCTION: The WHO End-TB Strategy calls for the development of novel diagnostics to detect tuberculosis (TB) earlier and more accurately. Better diagnostics, together with tools to predict disease progression, are critical for achieving WHO End-TB targets. The Early Risk Assessment in TB Contacts by new diagnoStic tEsts (ERASE-TB) study aims to evaluate novel diagnostics and testing algorithms for early TB diagnosis and accurate prediction of disease progression among household contacts (HHCs) exposed to confirmed index cases in Mozambique, Tanzania and Zimbabwe. METHODS AND ANALYSIS: A total of 2100 HHCs (aged ≥10 years) of adults with microbiologically-confirmed pulmonary TB will be recruited and followed up at 6-month intervals for 18-24 months. At each time point, a WHO symptom screen and digital chest radiograph (dCXR) will be performed, and blood and urine samples will be collected. Individuals screening positive (WHO symptom screen or dCXR) will be requested to provide sputum for Xpert MTB/Rif Ultra. At baseline, HHCs will also be screened for HIV, diabetes (HbA1c), chronic lung disease (spirometry), hypertension and anaemia. Study outcomes will be coprevalent TB (diagnosed at enrolment), incident TB (diagnosed during follow-up) or no TB at completion of follow-up. Novel diagnostics will be validated using fresh and biobanked samples with a nested case-control design. Cases are defined as HHCs diagnosed with TB (for early diagnosis) or with incident TB (for prediction of progression) and will be matched by age, sex and country to HHCs who remain healthy (controls). Statistical analyses will include assessment of diagnostic accuracy by constructing receiver operating curves and calculation of sensitivity and specificity. ETHICS AND DISSEMINATION: ERASE-TB has been approved by regulatory and ethical committees in each African country and by each partner organisation. Consent, with additional assent for participants <18 years, is voluntary. Attestation by impartial witnesses is sought in case of illiteracy. Confidentiality of participants is being maintained throughout. Study findings will be presented at scientific conferences and published in peer-reviewed international journals. TRIAL REGISTRATION NUMBER: NCT04781257.Cite Now.


Subject(s)
Diagnostic Tests, Routine , Tuberculosis , Adult , Child , Humans , Prospective Studies , Cohort Studies , Risk Assessment , Disease Progression , Tanzania
16.
Methods Mol Biol ; 2511: 53-65, 2022.
Article in English | MEDLINE | ID: covidwho-1941366

ABSTRACT

COVID-19 disease caused by the novel SARS-CoV-2 virus represents a new challenge for healthcare systems. The molecular confirmation of infection is crucial to guide public health decision-making. This task could be made more difficult during the next influenza season. Thus, a rapid and user-friendly diagnostic test to discriminate SARS-CoV-2 from influenza viruses is urgently needed. Here, we present a multiplex quantitative polymerase chain reaction (qPCR) assay capable of distinguishing SARS-CoV-2 from influenza A and B cases. This assay benefits from the use of an inhibitor tolerant PCR mix which obviates the need for the rate-limiting extraction step, allowing for a more rapid and accurate analysis.


Subject(s)
COVID-19 , Herpesvirus 1, Cercopithecine , Influenza A virus , Influenza, Human , COVID-19/diagnosis , Diagnostic Tests, Routine , Humans , Influenza A virus/genetics , Influenza B virus , Influenza, Human/diagnosis , Multiplex Polymerase Chain Reaction , Real-Time Polymerase Chain Reaction , SARS-CoV-2/genetics , Sensitivity and Specificity
17.
J Occup Environ Med ; 64(1): 58-63, 2022 01 01.
Article in English | MEDLINE | ID: covidwho-1931932

ABSTRACT

OBJECTIVES: Before community transmission of COVID-19 was recognized in the United States, cruise ship passengers with high risk for exposure to SARS-CoV-2 were repatriated and quarantined. We describe cases of influenza-like illness (ILI) among responders. METHODS: We reviewed situation reports and responder illness reports to characterize ill responders, including illness onset date, symptoms, fever, diagnostic tests, potential breaches in PPE use, and return to work status. RESULTS: Among 339 responders, nine (3%) reported ILI. No breaches in PPE were reported. Three responders with ILI were tested for both SARS-CoV-2 infection and influenza A; none tested positive for SARS-CoV-2 infection and two tested positive for influenza A. CONCLUSIONS: Despite an outbreak of ILI among responders, none were diagnosed with COVID-19, suggesting preventive measures in place might have been sufficient to prevent responders from SARS-CoV-2 exposure.


Subject(s)
COVID-19 , Influenza, Human , Diagnostic Tests, Routine , Humans , Influenza, Human/epidemiology , Influenza, Human/prevention & control , Quarantine , SARS-CoV-2 , Ships , United States/epidemiology
19.
Radiol Med ; 127(7): 754-762, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1899296

ABSTRACT

INTRODUCTION: According to the Chinese Health Commission guidelines, coronavirus disease 2019 (COVID-19) severity is classified as mild, moderate, severe, or critical. The mortality rate of COVID-19 is higher among patients with severe and critical diseases; therefore, early identification of COVID-19 prevents disease progression and improves patient survival. Computed tomography (CT) radiomics, as a machine learning method, provides an objective and mathematical evaluation of COVID-19 pneumonia. As CT-based radiomics research has recently focused on COVID-19 diagnosis and severity analysis, this meta-analysis aimed to investigate the predictive power of a CT-based radiomics model in determining COVID-19 severity. MATERIALS AND METHODS: This study followed the diagnostic version of PRISMA guidelines. PubMed, Embase databases and the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews were searched to identify relevant articles in the meta-analysis from inception until July 16, 2021. The sensitivity and specificity were analyzed using forest plots. The overall predictive power was calculated using the summary receiver operating characteristic curve. The bias was evaluated using a funnel plot. The quality of the included literature was assessed using the radiomics quality score and quality assessment of diagnostic accuracy studies tool. RESULTS: The radiomics quality scores ranged from 7 to 16 (achievable score: 2212 8 to 36). The pooled sensitivity and specificity were 0.800 (95% confidence interval [CI] 0.662-0.891) and 0.874 (95% CI 0.773-0.934), respectively. The pooled area under the receiver operating characteristic curve was 0.908. The quality assessment tool showed favorable results. CONCLUSION: This meta-analysis demonstrated that CT-based radiomics models might be helpful for predicting the severity of COVID-19 pneumonia.


Subject(s)
COVID-19 Testing , COVID-19 , Tomography, X-Ray Computed , COVID-19/diagnosis , COVID-19 Testing/standards , Diagnostic Tests, Routine , Humans , Sensitivity and Specificity , Tomography, X-Ray Computed/methods
20.
J Med Virol ; 94(10): 4754-4761, 2022 10.
Article in English | MEDLINE | ID: covidwho-1894609

ABSTRACT

Polymerase chain reaction (PCR) and antigen tests have been used extensively for screening during the severe acute respiratory syndrome coronavirus 2 pandemics. However, the real-world sensitivity and specificity of the two testing procedures in the field have not yet been estimated without assuming that the PCR constitutes a gold standard test. We use latent class models to estimate the in situ performance of both tests using data from the Danish national registries. We find that the specificity of both tests is very high (>99.7%), while the sensitivities are 95.7% (95% confidence interval [CI]: 92.8%-98.4%) and 53.8% (95% CI: 49.8%-57.9%) for the PCR and antigen tests, respectively. These findings have implications for the use of confirmatory PCR tests following a positive antigen test result: we estimate that serial testing is counterproductive at higher prevalence levels.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/diagnosis , COVID-19 Testing , Diagnostic Tests, Routine , Humans , Latent Class Analysis , Pandemics , SARS-CoV-2/genetics , Sensitivity and Specificity
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