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

Author(s):  
Oana Bulilete ◽  
Patricia Lorente ◽  
Alfonso Leiva ◽  
Eugenia Carandell ◽  
Antonio Oliver ◽  
...  

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.

2021 ◽  
Author(s):  
Rainer Thell ◽  
Verena Kallab ◽  
Wolfgang Weinhappel ◽  
Wolfgang Mueckstein ◽  
Lukas Heschl ◽  
...  

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.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jon Pallon ◽  
Mattias Rööst ◽  
Martin Sundqvist ◽  
Katarina Hedin

Abstract Background Few studies on pharyngotonsillitis have examined the clinical presentation of different aetiologies where pathogens have been detected using molecular methods. We aimed to assess how well clinical signs and symptoms can predict (1) the presence or absence of a broad range of viruses and bacteria, and (2) reconsultations for a sore throat or a complication. Methods In this descriptive observational prospective study in primary health care 220 patients aged 15–45 with suspected pharyngotonsillitis were sampled from nose, throat and blood and screened for 20 bacteria and viruses using polymerase chain reaction (PCR), culture and serology. Odds ratios (OR) and predictive values with 95% confidence intervals (CI) were used to show association between microbiological findings and clinical signs and symptoms. Patients were followed up after 3 months by reviewing electronic medical records. Results Both cough and coryza were more common in patients with only viruses (67%) than in patients with only bacteria (21%) (p < 0.001), whereas tonsillar coating was more common in patients with only bacteria (53%) than in patients with only viruses (29%) (p = 0.006). Tonsillar coating (adjusted OR 6.0; 95% CI 2.5–14) and a lack of cough (adjusted OR 3.5; 95% CI 1.5–8.0) were significantly associated with Streptococcus pyogenes (group A streptococci; GAS) and with any bacterial finding. A Centor score of 3–4 had a positive predictive value of 49% (95% CI 42–57) for GAS and 66% (95% CI 57–74) for any bacterial findings. The use of rapid antigen detection test for GAS increased the positive predictive value for this group to 93%. Conclusions Signs and symptoms, both single and combined, were insufficient to rule in GAS or other pathogens. However, both cough and coryza were useful to rule out GAS. The results support the clinical approach of restricting rapid antigen detection testing to patients with 3–4 Centor criteria. The low carriage rate of bacteria among asymptomatic controls implied that most detections in patients represented a true infection.


2021 ◽  
Author(s):  
Ruth Tsigebrhan ◽  
Abebaw Fekadu ◽  
Girmay Medhin ◽  
Charles R. Newton ◽  
Martin J. Prince ◽  
...  

Abstract Background: Timely detection and management of comorbid mental disorders in people with epilepsy is essential to improve outcomes. The objective of this study was to measure the performance of primary health care (PHC) workers in identifying comorbid mental disorders in people with epilepsy against a standardised reference diagnosis and a screening instrument in rural Ethiopia.Methods: People with active convulsive epilepsy were identified from the community, with confirmatory diagnosis by trained PHC workers. Documented diagnosis of comorbid mental disorders by PHC workers was extracted from clinical records. The standardized reference measure for diagnosing mental disorders was the Operational Criteria for Research (OPCRIT plus) administered by psychiatric nurses. The mental disorder screening scale (Self-Reporting Questionnaire; SRQ-20), was administered by lay data collectors. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of PHC worker diagnosis against the reference standard diagnosis was calculated. Logistic regression was used to examine the factors associated with misdiagnosis of comorbid mental disorder by PHC workers. Results: A total of 237 people with epilepsy were evaluated. The prevalence of mental disorders with standardised reference diagnosis was 13.9% (95% confidence interval (CI) 9.6%, 18.2%) and by PHC workers was 6.3% (95%CI 3.2%, 9.4%). The prevalence of common mental disorder using SRQ-20 at optimum cut-off point (9 or above) was 41.5% (95% CI 35.2%, 47.8%). The sensitivity and specificity of PHC workers diagnosis was 21.1% and 96.1%, respectively, compared to the standardised reference diagnosis. In those diagnosed with comorbid mental disorders by PHC workers, only 6 (40%) had SRQ-20 score of 9 or above. When a combination of both diagnostic methods (SRQ-20 score ≥9 and PHC diagnosis of depression) was compared with the standardised reference diagnosis of depression, sensitivity increased to 78.9% (95% (CI) 73.4, 84.4%) with specificity of 59.7% (95% CI 53.2, 66.2%). Only older age was significantly associated with misdiagnosis of comorbid mental disorders by PHC (adjusted odds ratio, 95% CI= 1.06, 1.02 to 1.11).Conclusion: Routine detection of co-morbid mental disorder in people with epilepsy was very low. Combining clinical judgement with use of a screening scale holds promise but needs further evaluation.


2020 ◽  
pp. 205064062094971 ◽  
Author(s):  
Noel Pin-Vieito ◽  
Laura García Nimo ◽  
Luis Bujanda ◽  
Begoña Román Alonso ◽  
María Ángeles Gutiérrez-Stampa ◽  
...  

Background Optimizing colonoscopy resources is challenging, and information regarding performing diagnostic quantitative faecal immunochemical test (FIT) in daily clinical practice in primary health care is still limited. This study aimed to assess the sensitivity, specificity, positive predictive value and negative predictive value of varying FIT positivity thresholds on colorectal cancer (CRC) detection in primary health care. Methods A retrospective cohort study of 38,675 asymptomatic and symptomatic patients with a FIT (OC-Sensor™) performed between 2012 and 2016 in a primary health-care setting, using a clinical laboratory database of two Spanish areas linked with the National Health System’s Hospital Discharge Records Database. The primary outcome was 2-year CRC incidence. Results The mean age of the participants was 63.2 years; 17,792 (46.0%) were male. CRC prevalence was 1.7% (650/38,675). The percentage of patients with a FIT result above the threshold was 20.7% and 14.6% for 10 µg Hb/g faeces and 20 µg Hb/g faeces thresholds, respectively. Sensitivity was 90.5% (95% confidence interval 88.0–92.5%) at a 10 µg Hb/g faeces threshold, and this decreased by 3.1% when a 20 µg Hb/g faeces threshold was used. The negative predictive value for CRC was at least 99.2% in any subgroup analysed. At a 20 µg Hb/g faeces threshold, less than one additional CRC would be missed per 1000 patients investigated, while approximately 1.3 times more colonoscopy examinations were needed to identify an incidence of CRC using the lowest threshold for any situation analysed. Conclusions In primary health care, a quantitative FIT threshold should be tailored to colonoscopy capacity and CRC prevalence in specific populations.


2019 ◽  
Vol 53 ◽  
pp. 26 ◽  
Author(s):  
Samira Monteiro Silva ◽  
Alfredo Nicodemos Cruz Santana ◽  
Nayhane Nayara Barbosa da Silva ◽  
Maria Rita Carvalho Garbi Novaes

OBJECTIVE: To determine Vulnerable Elders Survey (VES-13) and WHOQOL-bref cutoff points to detect poor quality of life (QoL) in older individuals. METHODS: This is a cross-sectional study, performed in all primary health care units in Samambaia, DF, Brazil. The data were collected from August 2016 to May 2017. The sample size of 466 older individuals treated in primary health care was obtained considering a 5% margin of error, 95% confidence level, 50% prevalence, and 20% possible losses, in a population of 13,259 older individuals. The subjects answered the VES-13 and WHOQOL-bref questionnaires. They were divided into 3 subgroups: poorQoL (older individuals with self-reported very poor or poor QoL AND very dissatisfied or dissatisfied with their health), goodQoL (very good or good QoL AND very satisfied or satisfied with Health) and indeterminateQoL (NOT belonging to poorQoL or goodQoL subgroups). A receiver-operating characteristic (ROC) curve was performed with poorQoL (case) versus goodQoL (control) to determine the cutoff score in VES-13 and WHOQOLbref. A diagnostic test using these cutoffs was carried out in all older individuals (n = 466). RESULTS: The VES-13 and WHOQOL-bref cutoff points to detect poorQoL were ≥ 2 and < 60, respectively. The area under ROC curve of VES-13 and WHOQOL-bref was 0.741 (CI95% 0.659- 0.823; p < 0.001) and 0.934 (CI95% 0.881-0.987; p < 0.001), respectively. In diagnostic tests, VES-13 showed 84% sensitivity and 98.2% negative predictive value, and WHOQOL-bref, 88% sensitivity and 99% negative predictive value. CONCLUSIONS: VES-13 score ≥ 2 and WHOQOL-bref score < 60 adequately detected poorQoL in patients treated in primary health care. Our data suggest that older individuals with these scores require special treatment such as geriatrics collaborative care to improve this scenario, considering QoL impact on mortality.


2012 ◽  
Vol 124 (17-18) ◽  
pp. 633-638 ◽  
Author(s):  
Kathryn Hoffmann ◽  
Berthold Reichardt ◽  
Sonja Zehetmayer ◽  
Manfred Maier

Author(s):  
Sara Shoman ◽  
Tamer Emara ◽  
Heba Gamal Saber ◽  
Mohamed Allam

Background: Telehealth is delivering health care services remote from healthcare facilities using telecommunications and virtual technology. Egypt is aiming to reach Universal Health Coverage; this increases the demand of telehealth in routine health services. Telehealth benefits are increasing access to expertise in difficultly reached geographical areas with no available medical teams and may be used as fast first aid. It could also minimize costs of hospitals, as patients can be monitored remotely even from home. As for barriers, especially in developing countries, are the unavailable infrastructure and the resistance of patients. Objective: To measure the awareness of telehealth among attendees of primary health care units and their acceptance of application of telehealth. Methodology: This was a cross sectional study among attendees of primary health units. A sample size was calculated to be 162. A valid Arabic interview questionnaire was designed, and 170 questionnaires were filled by attendees. Ethical issues were considered. Results: Awareness percentage of telehealth among attendees was 64.7% while willingness to implement telehealth was 78%. Both awareness and willingness were significantly associated with age groups, residence, socioeconomic status and presence of computer with net access. Conclusion: It is concluded that a large percentage of attendees to primary health care centers are aware of telehealth and are willing to implement it. The major cause of refusal to implement telehealth was due ignorance of using telecommunication devices and the desire to be in close contact with the physicians.


2013 ◽  
Vol 21 (5) ◽  
pp. 1159-1164 ◽  
Author(s):  
Tania Cristina Morais Santa Barbara Rehem ◽  
Maria Regina Fernandes de Oliveira ◽  
Suely Itsuko Ciosak ◽  
Emiko Yoshikawa Egry

OBJECTIVE: to estimate the sensitivity, specificity and positive and negative predictive values of the Unified Health System's Hospital Information System for the appropriate recording of hospitalizations for ambulatory care-sensitive conditions. METHOD: the hospital information system records for conditions which are sensitive to ambulatory care, and for those which are not, were considered for analysis, taking the medical records as the gold standard. Through simple random sampling, a sample of 816 medical records was defined and selected by means of a list of random numbers using the Statistical Package for Social Sciences. RESULT: the sensitivity was 81.89%, specificity was 95.19%, the positive predictive value was 77.61% and the negative predictive value was 96.27%. In the study setting, the Hospital Information System (SIH) was more specific than sensitive, with nearly 20% of care sensitive conditions not detected. CONCLUSION: there are no validation studies in Brazil of the Hospital Information System records for the hospitalizations which are sensitive to primary health care. These results are relevant when one considers that this system is one of the bases for assessment of the effectiveness of primary health care.


2019 ◽  
Vol 10 (2) ◽  
pp. 147
Author(s):  
Agholor Kin ◽  
Lucy F. Olusola ◽  
Idris Abubakar ◽  
Yakubu Mahmud

Plasmodium falciparum is the leading cause of malaria in pregnant women, a disease of public health importance especially in Nigeria where the infection is endemic. Hence, this study was conducted to ascertain the prevalent rate of Plasmodium falciparum infection among pregnant women attending antenatal in primary health care center, Wushishi Local Government, Niger state, Nigeria. 150 pregnant women were randomly selected and tested for P. falciparum using Plasmodium falciparum (05FK50) Rapid Diagnostic Test kit. The result obtained, revealed that 36 (24%) out of the 150 samples of the pregnant women were positive without any clinical manifestation of the infection. The result revealed that the prevalence rate was higher among women within 11-20 age group (43.8%) than those within 21-30 (17.4%) and 31 and above (9.0%). It was also observed from the study that prevalence rate was lower among women who use Insecticide Treated Net (6.5%) compared to those who does not (52.6%). Therefore the problem of Plasmodium falciparum infection in pregnant women should be prevented by the use of insecticide treated nets and effective case management with appropriate antimalarial drug during antenatal clinical visits.


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