scholarly journals Evaluation of a novel, rapid antigen detection test for the diagnosis of SARS-CoV-2

2021 ◽  
Author(s):  
Rainer Thell ◽  
Verena Kallab ◽  
Wolfgang Weinhappel ◽  
Wolfgang Mueckstein ◽  
Lukas Heschl ◽  
...  
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Emergency Departments ◽  
Rapid Test ◽  
Antigen Test ◽  
Rt Pcr ◽  
Likelihood Ratios ◽  
Predictive Values ◽  
Cycle Threshold ◽  
Primary Health

ABSTRACTBackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease 2019 (COVID-19) is currently finally determined in laboratory settings by real-time reverse-transcription polymerase-chain-reaction (rt-PCR). However, simple testing with immediately available results are crucial to gain control over COVID-19. The aim was to evaluate such a point-of-care antigen rapid test (AG-rt) device in its performance compared to laboratory-based rt-PCR testing in COVID-19 suspected, symptomatic patients.MethodsFor this prospective study, two specimens each of 541 symptomatic female (54.7%) and male (45.3%) patients aged between 18 and 95 years tested at five emergency departments (ED, n=296) and four primary healthcare centres (PHC, n=245), were compared, using AG-rt (positive/negative/invalid) and rt-PCR (positive/negative and cycle threshold, Ct) to diagnose SARS-CoV-2. Diagnostic accuracy, sensitivity, specificity, positive predictive values (PPV), negative predictive value (NPV), and likelihood ratios (LR+/-) of the AG-rt were assessed.ResultsDifferences between ED and PHC were detected regarding gender, age, symptoms, disease prevalence, and diagnostic performance. Overall, 174 (32.2%) were tested positive on AG-rt and 213 (39.4%) on rt-PCR. AG correctly classified 91.7% of all rt-PCR positive cases with a sensitivity of 80.3%, specificity of 99.1%, PPV of 98.3, NPV of 88.6%, LR(+) of 87.8, and LR(-) of 0.20. The highest sensitivities and specificities of AG-rt were detected in PHC (sensitivity: 84.4%, specificity: 100.0%), when using Ct of 30 as cut-off (sensitivity: 92.5%, specificity: 97.8%), and when symptom onset was within the first three days (sensitivity: 82.9%, specificity: 99.6%).ConclusionsThe highest sensitivity was detected with a high viral load. Our findings suggest that AG-rt are comparable to rt-PCR to diagnose SARS-CoV-2 in COVID-19 suspected symptomatic patients presenting both at emergency departments and primary health care centres.SUMMARYThe rapid SARS-Cov-2 antigen test (SARS-CoV-2 Rapid Antigen Test (Roche Diagnostics), was compared in symptomatic patients with PCR testing both in emergency departments and primary health care centres. It showed an overall sensitivity of 80.3% and specificity of 99.1%; these were higher with lower PCR cycle threshold numbers and with a shorter onset of symptoms.

scholarly journals Evaluation of the Panbio™ rapid antigen test for SARS-CoV-2 in primary health care centers and test sites

2020 ◽  
Author(s):  
Oana Bulilete ◽  
Patricia Lorente ◽  
Alfonso Leiva ◽  
Eugenia Carandell ◽  
Antonio Oliver ◽  
...  
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Predictive Value ◽  
Close Contact ◽  
Performance Characteristics ◽  
Antigen Test ◽  
Rt Pcr ◽  
Predictive Values ◽  
Primary Health ◽  
Test Kit

AbstractBackgroundRapid antigen tests (Ag-RDT) are emerging as new diagnostic tools for COVID-19 and real-world evaluations are needed to establish their performance characteristics.Main objectiveTo evaluate the accuracy of the Panbio™ Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard.MethodsThis was a prospective diagnostic study conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing either for suggestive symptoms of infection or a close contact, were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio™ rapid antigen test kit for SARS-CoV-2. The sensitivity and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group.ResultsA total of 1369 participants were included; mean age 42.5 ± 14.9 years and 54.3% women. The overall prevalence was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms or close contact, and more than 70% had high viral loads. The overall sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was higher in symptomatic patients, in those arriving within 5 days since symptom onset and in those with high viral load.ConclusionAg-RDT had relatively good performance characteristics in suspected symptomatic patients within five days since the onset of symptoms. However, our results concludes that a negative Ag-RDT in these settings must be considered as presumptive.

scholarly journals Evaluation of a novel, rapid antigen detection test for the diagnosis of SARS-CoV-2

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259527
Author(s):  
Rainer Thell ◽  
Verena Kallab ◽  
Wolfgang Weinhappel ◽  
Wolfgang Mueckstein ◽  
Lukas Heschl ◽  
...  
Keyword(s):  
Emergency Departments ◽  
Point Of Care ◽  
Gain Control ◽  
Rapid Test ◽  
High Viral Load ◽  
Rt Pcr ◽  
Likelihood Ratios ◽  
Predictive Values ◽  
Rapid Antigen Detection Test ◽  
Sensitivity Specificity

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease 2019 (COVID-19) is currently finally determined in laboratory settings by real-time reverse-transcription polymerase-chain-reaction (rt-PCR). However, simple testing with immediately available results are crucial to gain control over COVID-19. The aim was to evaluate such a point-of-care antigen rapid test (AG-rt) device in its performance compared to laboratory-based rt-PCR testing in COVID-19 suspected, symptomatic patients. Methods For this prospective study, two specimens each of 541 symptomatic female (54.7%) and male (45.3%) patients aged between 18 and 95 years tested at five emergency departments (ED, n = 296) and four primary healthcare centres (PHC, n = 245), were compared, using AG-rt (positive/negative/invalid) and rt-PCR (positive/negative and cycle threshold, Ct) to diagnose SARS-CoV-2. Diagnostic accuracy, sensitivity, specificity, positive predictive values (PPV), negative predictive value (NPV), and likelihood ratios (LR+/-) of the AG-rt were assessed. Results Differences between ED and PHC were detected regarding gender, age, symptoms, disease prevalence, and diagnostic performance. Overall, 174 (32.2%) were tested positive on AG-rt and 213 (39.4%) on rt-PCR. AG correctly classified 91.7% of all rt-PCR positive cases with a sensitivity of 80.3%, specificity of 99.1%, PPV of 98.3, NPV of 88.6%, LR(+) of 87.8, and LR(-) of 0.20. The highest sensitivities and specificities of AG-rt were detected in PHC (sensitivity: 84.4%, specificity: 100.0%), when using Ct of 30 as cut-off (sensitivity: 92.5%, specificity: 97.8%), and when symptom onset was within the first three days (sensitivity: 82.9%, specificity: 99.6%). Conclusions The highest sensitivity was detected with a high viral load. Our findings suggest that AG-rt are comparable to rt-PCR to diagnose SARS-CoV-2 in COVID-19 suspected symptomatic patients presenting both at emergency departments and primary health care centres.

scholarly journals Chronic substance use and self-harm in a primary health care setting

2018 ◽  
Vol 10 (1) ◽  
Author(s):  
Elsie Breet ◽  
Jason Bantjes ◽  
Ian Lewis
Keyword(s):  
Primary Care ◽  
Health Care ◽  
Substance Use ◽  
Primary Health Care ◽  
Emergency Departments ◽  
Service Utilisation ◽  
Health Care Settings ◽  
Primary Health ◽  
Self Harm ◽  
Primary Health Care Settings

Background: Chronic substance use (CSU) is associated with health problems, including selfharm, placing a significant burden on health care resources and emergency departments (EDs). This is problematic in low- and middle-income countries like South Africa (SA), where primary care facilitates and emergency departments (EDs) are often poorly resourced.Aim: To investigate the epidemiology of CSU and self-harm and to consider the implications for primary health care service delivery and suicide prevention in SA.Methods: Data were collected from 238 consecutive self-harm patients treated at the emergency department (ED) of an urban hospital in SA. The data were analysed using bivariate and multivariate analyses.Results: Approximately 37% of self-harm patients reported CSU. The patients in the CSU subgroup, compared to other self-harm patients, were more likely to be men (odds ratio[OR] = 8.33, 95% confidence interval [CI] = 3.19–20.9, p < 0.001), to have self-harmed by inflicting damage to their body tissue OR = 4.45, 95% CI = 1.77–11.2, p < 0.01) and to have a history of self-harm (OR = 3.71, 95% CI = 1.44–9.54, p = 0.007). A significantly smaller proportion of CSU patients, compared to other self-harm patients, were referred for psychiatric assessment (OR = 8.05, 95% CI = 4.16–15.7, p < 0.001).Conclusion: The findings of this study confirm that CSU is associated with greater service utilisation and repetition of self-harm among patients in primary health care settings. Treating self-harm as the presenting problem within primary care settings does not necessarily ensure that patients receive the care that they need. It might be helpful to include psychiatric assessments and screening for CSU as an integral component of care for self-harm patientswho present in primary health care settings.

Smear Microscopy Examination for Malaria and Tuberculosis at Primary Health Care Unit Level of Guragae Zone, Southern Ethiopia

2019 ◽  
Author(s):  
Teha Shumbej Gebi ◽  
Menu Sofia ◽  
Teklemichael Gebru ◽  
Solomon Absra ◽  
Kahase Daniel ◽  
...  
Keyword(s):  
Health Care ◽  
Quality Assurance ◽  
Primary Health Care ◽  
Plasmodium Species ◽  
Health Facilities ◽  
Southern Ethiopia ◽  
Smear Microscopy ◽  
Predictive Values ◽  
Primary Health ◽  
Health Care Unit

Abstract Background: Accurate early diagnosis and prompt treatment is one of the core strategies employed to address malaria and tuberculosis related problems. Laboratory confirmation improves disease management most efficiently within well-managed health laboratory systems. External quality assurance participation is associated with improved laboratory performance over time as it is a system for objectively checking a laboratory’s performance. However, many professionals in Sub Saharan Africa countries are unable to effectively implement a quality assurance program. This study aimed to assess the quality of smear microscopy in Guragae zone primary health care unit, Southern Ethiopia. Methods: Health institution-based cross-sectional study was conducted to recruit twenty-one primary health care units between May and August 2019. Blind rechecking was used to collect data. The sensitivity, specificity, positive predictive values, and negative predictive values were calculated by considering the final re-reading result as the gold standard. The level of agreement was measured using Kappa value. SPSS version 21 was used for data management and analysis. Result: A total of 860 and 318 stained slides for tuberculosis and malaria were collected, respectively. From total collected slides for tuberculosis, about 13.1 % of them were reported positive and from total malaria slides collected, half were positive for Plasmodium species at the peripheral laboratory while about 36.1% and 13% were confirmed positive for Plasmodium species and tuberculosis, respectively during re-reading at Wolkite University laboratory. Referring to the final result, the surveyed health facilities achieved “moderate agreement”(K=0.6) on malaria slide detection and “almost perfect agreement” (K=0.9) on slides for acid-fast bacilli. Only 4.4% of the surveyed health facilities incorporate malaria parasite count estimation in their report as per the current guideline. Conclusion: Now is the time to build sustainable laboratory capacity in resource-poor settings like Ethiopia that can be used to manage existing infectious diseases including malaria and tuberculosis. Malaria related technical problems were identified in this study. Thus, the authors believe that a continuous and strong malaria quality assurance schemes should be implemented at each laboratory to ensure reliable results.

scholarly journals Rapid antigen test for SARS-CoV-2 and primary health care

2021 ◽  
Author(s):  
T Fernández-Villa ◽  
A Vazquez-Casares ◽  
A Rivero-Rodriguez ◽  
A Carvajal-Ureña ◽  
V Martín
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Antigen Test ◽  
Primary Health

scholarly journals Weaknesses in primary health care favor the growth of acquired syphilis

2021 ◽  
Vol 15 (2) ◽  
pp. e0009085
Author(s):  
Marquiony Marques dos Santos ◽  
Tatyana Maria Silva de Souza Rosendo ◽  
Ana Karla Bezerra Lopes ◽  
Angelo Giuseppe Roncalli ◽  
Kenio Costa de Lima
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Population Size ◽  
Rapid Test ◽  
Multiple Model ◽  
Health Care Teams ◽  
Transmitted Infection ◽  
Partial Coverage ◽  
Primary Health ◽  
Female Condoms

Acquired syphilis is a sexually transmitted infection that affects the general population and has been growing in recent years in many countries. A study was developed aiming to analyze the trends of acquired syphilis associated with sociodemographic aspects and primary health care in Brazil, in the period from 2011 to 2019. This study used secondary data from the national notification systems of the 5570 Brazilian cities and a database of 37,350 primary health care teams, as well as socioeconomic and municipal demographic indicators. The trends of acquired syphilis at the municipal level were calculated from the log-linear regression, crossing them with variables of primary health care and sociodemographic indicators. Finally, a multiple model was built from logistic regression. 724,310 cases of acquired syphilis have been reported. In primary care units, 47.8% had partial coverage and 74.1% had health teams with poor or regular scores. 52.6% had rapid test for syphilis partially available. Male and female condoms are available in 85.9% and 62.9% respectively and 54.4% had penicillin available in the health facility. The increase in trends of acquired syphilis was associated with better availability of the rapid test; lower availability of male condoms; lower availability of female condoms; lower availability of benzathine penicillin; partial coverage of the teams in primary health care; limited application of penicillin in primary health care; higher proportion of teams classified as Poor/Regular in primary health care; higher proportion of women aged 10 to 17 years who had children; higher HDI; higher proportion of people aged 15 to 24 years who do not study, do not work and are vulnerable; and population size with more than 100,000 inhabitants. The following variables remained in the multiple model: not all primary health care teams apply penicillin; higher proportion of primary health care teams with poor/regular scores; population size >100000 inhabitants; partially available female condom. Thus, the weakness of primary health care linked to population size may have favored the growth of the acquired syphilis epidemic in Brazilian cities.

scholarly journals Implementing the Regulation of the Minister of Health by Polish Emergency Departments In 2020

2021 ◽  
Vol 8 (3) ◽  
pp. 144-149
Author(s):  
Jan Stachurski ◽  
Anna Kaczyńska ◽  
Zofia Czaplińska-Paszek
Keyword(s):  
Health Care ◽  
Emergency Department ◽  
Primary Health Care ◽  
Emergency Departments ◽  
Data Retrieval ◽  
Medical Centers ◽  
Primary Health ◽  
After Hours

Aim: The inadequate system of triage in Emergency Departments leads to the situation in which the personnel is not always able to provide care on time. A regulation determining the conditions of performing triage in Emergency Departments (paragraph 1, section 2) was issued on 27 June 2019. In order to present the level of the fulfilment of rules from the regulation and to determine the level of organization in the Polish health care, the percentage of Emergency Departments which provided the required information on their websites, was examined. Material and methods: The study was conducted in April 2020. 236 websites of hospitals with Emergency Departments were analyzed. The criteria of data retrieval were as follows: 1. The presence of the information concerning the rules of redirecting patients to Primary Health Care/After Hours Medical Centers. 2. The presence of information concerning the time an Emergency Department doctor has to inform the patient about the admission or about refusal to admit a patient. The collected data were statistically analyzed. Each Emergency Department was given the following statuses: “yes”, “no”, or “incomplete”. Results: Information concerning the 1st criterion were available in case of 59 hospitals (25%), while no such information was on the website in Opole and West Pomeranian Provinces. Information concerning the 2nd criterion was placed by 51 hospitals. In 28 cases the information was described as ”complete” and in 23 as “incomplete”. Conclusions: The majority of hospitals failed to observe the obligation to provide the information included in the Regulation.

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