Pub Date : 2022-11-01DOI: 10.1016/j.jcvp.2022.100123
Peace D. Imani , Peter J. Elyanu , R. Sebastian Wanless , Sarah H. Perry , Kanyamanda Katembo , Bhekumusa Lukhele , Teresa Steffy , Tumelo Seetane , Lineo Thahane , Heather Haq , Cynthia S. Bell , Poyyapakkam Srivaths , Michael C. Braun
Background
Chronic kidney disease (CKD) remains an important comorbid condition in people living with HIV. However, data in children living with HIV/AIDS (CLWHA) in sub-Saharan Africa is limited. We sought to establish the prevalence and identify risk factors of CKD among CLWHA in SSA.
Methods
This was a retrospective chart review across five SSA countries HIV/AIDS care sites, March 2000 and June 2016.
Results
4,859 children with at least two clinic visits were enrolled in the study. The median age at the first clinic visit was 5.7 (IQR; 2.5, 9.5) years, and median follow-up time was 22.6 (IQR 9.8, 46.1) months. 11.2% CLWHA had an eGFR of <60 mL/min/1.73m2 on at least one clinic visit. The prevalence of CKD was 1.6%. In a multivariable Poisson regression analysis, CKD was associated with severe immunosuppression, incident rate ratio (IRR) 2.69 (95% CI, 1.11, 6.51). Risk of CKD decreased with increasing age (IRR 0.51 (95% CI, 0.39, 0.67). There was no association between CKD and ART regimen.
Conclusion
CKD was not as prevalent as previously reported in children in other studies. Kidney function monitoring should be incorporated into the pediatric HIV care monitoring guidelines to allow for better evaluation of kidney disease in CLWHA.
{"title":"Chronic kidney disease among children living with the human immunodeficiency virus in sub-Saharan Africa","authors":"Peace D. Imani , Peter J. Elyanu , R. Sebastian Wanless , Sarah H. Perry , Kanyamanda Katembo , Bhekumusa Lukhele , Teresa Steffy , Tumelo Seetane , Lineo Thahane , Heather Haq , Cynthia S. Bell , Poyyapakkam Srivaths , Michael C. Braun","doi":"10.1016/j.jcvp.2022.100123","DOIUrl":"10.1016/j.jcvp.2022.100123","url":null,"abstract":"<div><h3>Background</h3><p>Chronic kidney disease (CKD) remains an important comorbid condition in people living with HIV. However, data in children living with HIV/AIDS (CLWHA) in sub-Saharan Africa is limited. We sought to establish the prevalence and identify risk factors of CKD among CLWHA in SSA.</p></div><div><h3>Methods</h3><p>This was a retrospective chart review across five SSA countries HIV/AIDS care sites, March 2000 and June 2016.</p></div><div><h3>Results</h3><p>4,859 children with at least two clinic visits were enrolled in the study. The median age at the first clinic visit was 5.7 (IQR; 2.5, 9.5) years, and median follow-up time was 22.6 (IQR 9.8, 46.1) months. 11.2% CLWHA had an eGFR of <60 mL/min/1.73m<sup>2</sup> on at least one clinic visit. The prevalence of CKD was 1.6%. In a multivariable Poisson regression analysis, CKD was associated with severe immunosuppression, incident rate ratio (IRR) 2.69 (95% CI, 1.11, 6.51). Risk of CKD decreased with increasing age (IRR 0.51 (95% CI, 0.39, 0.67). There was no association between CKD and ART regimen.</p></div><div><h3>Conclusion</h3><p>CKD was not as prevalent as previously reported in children in other studies. Kidney function monitoring should be incorporated into the pediatric HIV care monitoring guidelines to allow for better evaluation of kidney disease in CLWHA.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"2 4","pages":"Article 100123"},"PeriodicalIF":1.7,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S266703802200062X/pdfft?md5=60608bf5d1de970818277cd854d01441&pid=1-s2.0-S266703802200062X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44524861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-11-01DOI: 10.1016/j.jcvp.2022.100122
Debele Mekonnen , Tesfaye Solomon , Mamo Nigatu
Background
Previous studies of blood donors in Ethiopia have focused on all types of donors without exposure screening before blood donation. The purpose of this study was to determine the prevalence of Hepatitis B virus and its predictors among volunteer blood donors in Jimma, Ethiopia.
Materials and methods
Cross-sectional study was conducted on sampled volunteer blood donors who were consecutively included from March 10 to April 20, 2018. Virus detection was investigated by testing for Hepatitis B surface antigen in the serum. Data collected through face-to-face interviews, has been cleaned and checked, entered into Data 3.1 and analyzed by statistical software SPSS version 20. The level of statistical significance was reported to be p<0.05 in the multivariable logistic regression.
Results
A total of 548 participants with 60.96% in the 18–24 age group were participated and the overall prevalence of HBV infection was 2.92%. The test positivity rate among males was 12/268 (4.48%) and while the rate among females was 4/280 (1.43%). More than 80% of those who tested positive were under the age of 35 years. Being male [AOR=3.28, 95%CI: 1.01–10.68], age 18–24 [AOR=0.17, 95%CI: 0.36–0.78], frequency of donation [AOR= 0.25, 95%CI: 0.08–0.76], and exposure to unsafe injection [AOR= 6.98, 95%CI: 1.66–29.29] were significant factors.
Conclusion
The overall prevalence of HBsAg was intermediate with positivity higher in males. Furthermore, age, frequency of donation and exposure to unsafe therapeutic drug injection were independent predictors. Therefore, the blood bank should raise awareness to repeat volunteer young donors and focus on identified low-risk groups.
{"title":"Prevalence of Hepatitis B virus and its predictors among volunteer blood donors in Jimma, Ethiopia, 2018: A cross-sectional study","authors":"Debele Mekonnen , Tesfaye Solomon , Mamo Nigatu","doi":"10.1016/j.jcvp.2022.100122","DOIUrl":"10.1016/j.jcvp.2022.100122","url":null,"abstract":"<div><h3>Background</h3><p>Previous studies of blood donors in Ethiopia have focused on all types of donors without exposure screening before blood donation. The purpose of this study was to determine the prevalence of Hepatitis B virus and its predictors among volunteer blood donors in Jimma, Ethiopia.</p></div><div><h3>Materials and methods</h3><p>Cross-sectional study was conducted on sampled volunteer blood donors who were consecutively included from March 10 to April 20, 2018. Virus detection was investigated by testing for Hepatitis B surface antigen in the serum. Data collected through face-to-face interviews, has been cleaned and checked, entered into Data 3.1 and analyzed by statistical software SPSS version 20. The level of statistical significance was reported to be p<0.05 in the multivariable logistic regression.</p></div><div><h3>Results</h3><p>A total of 548 participants with 60.96% in the 18–24 age group were participated and the overall prevalence of HBV infection was 2.92%. The test positivity rate among males was 12/268 (4.48%) and while the rate among females was 4/280 (1.43%). More than 80% of those who tested positive were under the age of 35 years. Being male [AOR=3.28, 95%CI: 1.01–10.68], age 18–24 [AOR=0.17, 95%CI: 0.36–0.78], frequency of donation [AOR= 0.25, 95%CI: 0.08–0.76], and exposure to unsafe injection [AOR= 6.98, 95%CI: 1.66–29.29] were significant factors.</p></div><div><h3>Conclusion</h3><p>The overall prevalence of HBsAg was intermediate with positivity higher in males. Furthermore, age, frequency of donation and exposure to unsafe therapeutic drug injection were independent predictors. Therefore, the blood bank should raise awareness to repeat volunteer young donors and focus on identified low-risk groups.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"2 4","pages":"Article 100122"},"PeriodicalIF":1.7,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2667038022000618/pdfft?md5=09fbac6ea6925b06b927f2503ca6ae22&pid=1-s2.0-S2667038022000618-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48487207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-11-01DOI: 10.1016/j.jcvp.2022.100121
Lorena O. Fernandes-Siqueira , Bruna G. Sousa , Carlos E. Cleto , Luciana S. Wermelinger , Beatriz L.L. Caetano , Agatha R. Pacheco , Simone M. Costa , Fabio C.L. Almeida , Gustavo C. Ferreira , Didier Salmon , Ada M.B. Alves , Andrea T. Da Poian
Background
Vaccination against COVID-19 was implemented very quickly, but the emergence of new variants that can evade the previous acquired immunological protection highlights the importance of understanding the mechanisms involved in the immune response generated after SARS-CoV-2 infection or vaccination.
Objectives
Since most of our knowledge on the humoral immunity generated against SARS-CoV-2 has been obtained from studies with infected patients before vaccination, our goal here was to evaluate seroconversion and its correlation with the titers of neutralizing antibodies (NAbs) in individuals who received the complete initial recommended vaccination schedule with three different vaccines.
Study design
We analyzed serum IgG, IgA and total NAbs against the trimeric SARS-CoV-2 Spike (S) protein or its receptor binding domain (RBD) in blood samples collected from 118 healthy individuals without known previous infection, before and after receiving the first and the second dose of CoronaVac (n = 18), ChAdOx-1 (n = 68) or BNT162b2 (n = 32) vaccines.
Results
We found that although IgG titers were high in all sera collected after the two doses of these vaccines, NAbs amounts varies among the groups. In contrast, serum NAbs concentrations were much more comparable to the IgA levels, indicating that these antibodies would have a major neutralizing capacity against SARS-CoV-2.
Conclusions
Altogether our data suggest that quantification of serum anti-S or anti-RBD IgA, rather than IgG, may be a valuable tool to screen NAbs and may be considered for surveillance of vaccine coverage.
{"title":"IgA quantification as a good predictor of the neutralizing antibodies levels after vaccination against SARS-CoV-2","authors":"Lorena O. Fernandes-Siqueira , Bruna G. Sousa , Carlos E. Cleto , Luciana S. Wermelinger , Beatriz L.L. Caetano , Agatha R. Pacheco , Simone M. Costa , Fabio C.L. Almeida , Gustavo C. Ferreira , Didier Salmon , Ada M.B. Alves , Andrea T. Da Poian","doi":"10.1016/j.jcvp.2022.100121","DOIUrl":"10.1016/j.jcvp.2022.100121","url":null,"abstract":"<div><h3>Background</h3><p>Vaccination against COVID-19 was implemented very quickly, but the emergence of new variants that can evade the previous acquired immunological protection highlights the importance of understanding the mechanisms involved in the immune response generated after SARS-CoV-2 infection or vaccination.</p></div><div><h3>Objectives</h3><p>Since most of our knowledge on the humoral immunity generated against SARS-CoV-2 has been obtained from studies with infected patients before vaccination, our goal here was to evaluate seroconversion and its correlation with the titers of neutralizing antibodies (NAbs) in individuals who received the complete initial recommended vaccination schedule with three different vaccines.</p></div><div><h3>Study design</h3><p>We analyzed serum IgG, IgA and total NAbs against the trimeric SARS-CoV-2 Spike (S) protein or its receptor binding domain (RBD) in blood samples collected from 118 healthy individuals without known previous infection, before and after receiving the first and the second dose of CoronaVac (<em>n</em> = 18), ChAdOx-1 (<em>n</em> = 68) or BNT162b2 (<em>n</em> = 32) vaccines.</p></div><div><h3>Results</h3><p>We found that although IgG titers were high in all sera collected after the two doses of these vaccines, NAbs amounts varies among the groups. In contrast, serum NAbs concentrations were much more comparable to the IgA levels, indicating that these antibodies would have a major neutralizing capacity against SARS-CoV-2.</p></div><div><h3>Conclusions</h3><p>Altogether our data suggest that quantification of serum anti-S or anti-RBD IgA, rather than IgG, may be a valuable tool to screen NAbs and may be considered for surveillance of vaccine coverage.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"2 4","pages":"Article 100121"},"PeriodicalIF":1.7,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9635250/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9462838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-11-01DOI: 10.1016/j.jcvp.2022.100114
Francesco Branda , Massimo Pierini , Sandra Mazzoli
<div><h3>Background</h3><p>The current out-of-Africa 2022 outbreak of Monkeypox requires a coordinated, international response through the rapid sharing of data and research results, as we have seen with COVID-19 and the previous Ebola and Zika outbreaks, which demonstrated how important real-world data are to inform public health, to create surveillance systems, to determine policy decisions and to improve clinical trials.</p></div><div><h3>Objectives</h3><p>To support global response efforts by providing public access to real-time Monkeypox-related data for effective use of open data that could accelerate scientific knowledge and discoveries in terms of understanding, preventing, and treating the disease. In practice, to create a new surveillance system easy to consult and utilize.</p></div><div><h3>Study design</h3><p>This work aims to build a surveillance system, namely EpiMPX, that allows researchers and policymakers to monitor the impact of Monkeypox in Europe, with a special focus on the epidemic trends in the Italian regions, based on an open-access database containing information on the laboratory confirmed Monkeypox cases reported by EU/EEA countries and updated once a week. In addition, users will be provided open-access R codes to estimate key epidemiological parameters such as the reproduction number (updating the Serial Interval distribution when new estimates will be published) and produce real-time results on their devices.</p></div><div><h3>Results</h3><p>EpiMPX monitors the space-time distribution of cases and their characteristics, such as age, gender, symptoms, clinical status, and sexual orientation, when available. Even if it is currently too early for reliable calculation of epidemiological parameters, we estimated reproduction number <span><math><msub><mrow><mi>R</mi></mrow><mrow><mi>t</mi></mrow></msub></math></span> in European countries with more than 28 days of observed incidence, assuming that the Serial Interval (SI) early estimate in Italy is valid for other countries too. This provides a direct visual assessment of the geographic distribution of risk areas as well as insights into the evolution of the outbreak over time. Italian data were evaluated concerning gender, region prevalence and cumulative data.</p></div><div><h3>Conclusions</h3><p>The proposed EpiMPX surveillance system provides an overview of the European and Italian Monkeypox epidemiological situation with an open-access database to support epidemiological understanding of the origins and transmission dynamics of the disease with informative graphical outputs. These data confirmed the prevalent expression of Monkeypox within males, both in Europe and Italy. European MSM patients were affected by Monkeypox in a high percentage, confirming close sexual contact and possible sexual transmission. For the first time, Italian data on the regional distribution of cases and gender distribution were graphically evaluated. The data and research results are freely
{"title":"Monkeypox: EpiMPX Surveillance System and Open Data with a Special Focus on European and Italian Epidemic","authors":"Francesco Branda , Massimo Pierini , Sandra Mazzoli","doi":"10.1016/j.jcvp.2022.100114","DOIUrl":"10.1016/j.jcvp.2022.100114","url":null,"abstract":"<div><h3>Background</h3><p>The current out-of-Africa 2022 outbreak of Monkeypox requires a coordinated, international response through the rapid sharing of data and research results, as we have seen with COVID-19 and the previous Ebola and Zika outbreaks, which demonstrated how important real-world data are to inform public health, to create surveillance systems, to determine policy decisions and to improve clinical trials.</p></div><div><h3>Objectives</h3><p>To support global response efforts by providing public access to real-time Monkeypox-related data for effective use of open data that could accelerate scientific knowledge and discoveries in terms of understanding, preventing, and treating the disease. In practice, to create a new surveillance system easy to consult and utilize.</p></div><div><h3>Study design</h3><p>This work aims to build a surveillance system, namely EpiMPX, that allows researchers and policymakers to monitor the impact of Monkeypox in Europe, with a special focus on the epidemic trends in the Italian regions, based on an open-access database containing information on the laboratory confirmed Monkeypox cases reported by EU/EEA countries and updated once a week. In addition, users will be provided open-access R codes to estimate key epidemiological parameters such as the reproduction number (updating the Serial Interval distribution when new estimates will be published) and produce real-time results on their devices.</p></div><div><h3>Results</h3><p>EpiMPX monitors the space-time distribution of cases and their characteristics, such as age, gender, symptoms, clinical status, and sexual orientation, when available. Even if it is currently too early for reliable calculation of epidemiological parameters, we estimated reproduction number <span><math><msub><mrow><mi>R</mi></mrow><mrow><mi>t</mi></mrow></msub></math></span> in European countries with more than 28 days of observed incidence, assuming that the Serial Interval (SI) early estimate in Italy is valid for other countries too. This provides a direct visual assessment of the geographic distribution of risk areas as well as insights into the evolution of the outbreak over time. Italian data were evaluated concerning gender, region prevalence and cumulative data.</p></div><div><h3>Conclusions</h3><p>The proposed EpiMPX surveillance system provides an overview of the European and Italian Monkeypox epidemiological situation with an open-access database to support epidemiological understanding of the origins and transmission dynamics of the disease with informative graphical outputs. These data confirmed the prevalent expression of Monkeypox within males, both in Europe and Italy. European MSM patients were affected by Monkeypox in a high percentage, confirming close sexual contact and possible sexual transmission. For the first time, Italian data on the regional distribution of cases and gender distribution were graphically evaluated. The data and research results are freely","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"2 4","pages":"Article 100114"},"PeriodicalIF":1.7,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9531934/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9092923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-11-01DOI: 10.1016/j.jcvp.2022.100112
Chandana Wijesinghe , Afzal A Jabeer , Bushran N Iqbal , Faseeha Noordeen
Dengue is a major viral disease affecting the tropics. Although previous research has focused on the relationship between the infecting dengue virus (DENV) serotypes and disease severity, less work has been done on the relationship between the clinical and laboratory features and the infecting DENV serotypes in Sri Lanka. We evaluated the relationship between the clinical and laboratory features and the infecting DENV serotypes in adult patients with clinically suspected dengue admitted to the Base Hospital, Mawanella, Sri Lanka from December 2015 to March 2017.
Blood samples of 200 dengue suspected patients were tested for the infecting DENV serotypes using a reverse transcription polymerase chain reaction with primers targeting the envelope region of the virus. Relationship between the infecting DENV serotypes with clinical and laboratory features was assessed using Z score and paired t tests.
Of the 200 patients tested, 39 (19.5%) were positive for DENV, any of the four DENV serotypes alone or in combination. The highest number of infections was noted with DENV-2 (n=18, 46.1%). Fever (P=0.000) and rash (P=0.017) were frequently noted in DENV negative patients while bleeding (P=0.012) was more frequently noted in DENV serotype positive patients. Platelet count of <100,000 μl−1 was significantly associated with DENV serotype positivity (P=0.000). Platelet count of <100,000 μl−1 (P=0.035) and haemoglobin (Hb) of >13mgdl−1 (P=0.016) were noted in 15 of the 18 DENV-2 positive patients.
Clinical and laboratory features of severe dengue with bleeding manifestations, low platelet counts and high Hb were noted in DENV-2 infections.
{"title":"Relationship between clinical and laboratory features with infecting dengue virus serotypes in a sample of dengue suspected adult patients from 2015-2017 in Sri Lanka","authors":"Chandana Wijesinghe , Afzal A Jabeer , Bushran N Iqbal , Faseeha Noordeen","doi":"10.1016/j.jcvp.2022.100112","DOIUrl":"10.1016/j.jcvp.2022.100112","url":null,"abstract":"<div><p>Dengue is a major viral disease affecting the tropics. Although previous research has focused on the relationship between the infecting dengue virus (DENV) serotypes and disease severity, less work has been done on the relationship between the clinical and laboratory features and the infecting DENV serotypes in Sri Lanka. We evaluated the relationship between the clinical and laboratory features and the infecting DENV serotypes in adult patients with clinically suspected dengue admitted to the Base Hospital, Mawanella, Sri Lanka from December 2015 to March 2017.</p><p>Blood samples of 200 dengue suspected patients were tested for the infecting DENV serotypes using a reverse transcription polymerase chain reaction with primers targeting the envelope region of the virus. Relationship between the infecting DENV serotypes with clinical and laboratory features was assessed using Z score and paired <em>t</em> tests.</p><p>Of the 200 patients tested, 39 (19.5%) were positive for DENV, any of the four DENV serotypes alone or in combination. The highest number of infections was noted with DENV-2 (n=18, 46.1%). Fever (<em>P</em>=0.000) and rash (<em>P</em>=0.017) were frequently noted in DENV negative patients while bleeding (<em>P</em>=0.012) was more frequently noted in DENV serotype positive patients. Platelet count of <100,000 μl<sup>−1</sup> was significantly associated with DENV serotype positivity (<em>P</em>=0.000). Platelet count of <100,000 μl<sup>−1</sup> (<em>P</em>=0.035) and haemoglobin (Hb) of >13mgdl<sup>−1</sup> (<em>P</em>=0.016) were noted in 15 of the 18 DENV-2 positive patients.</p><p>Clinical and laboratory features of severe dengue with bleeding manifestations, low platelet counts and high Hb were noted in DENV-2 infections.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"2 4","pages":"Article 100112"},"PeriodicalIF":1.7,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9732741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10360764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-08-17DOI: 10.1016/j.jcvp.2022.100103
Flávia F Bagno, Sarah A R Sérgio, Maria Marta Figueiredo, Lara C Godoi, Luis A F Andrade, Natália C Salazar, Camila P Soares, Andressa Aguiar, Flávia Jaqueline Almeida, Edimilson D da Silva, Antônio G P Ferreira, Edison Luiz Durigon, Ricardo T Gazzinelli, Santuza M R Teixeira, Ana Paula S M Fernandes, Flavio G da Fonseca
There is a massive demand to identify alternative methods to detect new cases of COVID-19 as well as to investigate the epidemiology of the disease. In many countries, importation of commercial kits poses a significant impact on their testing capacity and increases the costs for the public health system. We have developed an ELISA to detect IgG antibodies against SARS-CoV-2 using a recombinant viral nucleocapsid (rN) protein expressed in E. coli. Using a total of 894 clinical samples we showed that the rN-ELISA was able to detect IgG antibodies against SARS-CoV-2 with high sensitivity (97.5%) and specificity (96.3%) when compared to a commercial antibody test. After three external validation studies, we showed that the test accuracy was higher than 90%. The rN-ELISA IgG kit constitutes a convenient and specific method for the large-scale determination of SARS-CoV-2 antibodies in human sera with high reliability.
{"title":"DEVELOPMENT AND VALIDATION OF AN ENZYME-LINKED IMMUNOASSAY KIT FOR DIAGNOSIS AND SURVEILLANCE OF COVID-19.","authors":"Flávia F Bagno, Sarah A R Sérgio, Maria Marta Figueiredo, Lara C Godoi, Luis A F Andrade, Natália C Salazar, Camila P Soares, Andressa Aguiar, Flávia Jaqueline Almeida, Edimilson D da Silva, Antônio G P Ferreira, Edison Luiz Durigon, Ricardo T Gazzinelli, Santuza M R Teixeira, Ana Paula S M Fernandes, Flavio G da Fonseca","doi":"10.1016/j.jcvp.2022.100103","DOIUrl":"10.1016/j.jcvp.2022.100103","url":null,"abstract":"<p><p>There is a massive demand to identify alternative methods to detect new cases of COVID-19 as well as to investigate the epidemiology of the disease. In many countries, importation of commercial kits poses a significant impact on their testing capacity and increases the costs for the public health system. We have developed an ELISA to detect IgG antibodies against SARS-CoV-2 using a recombinant viral nucleocapsid (rN) protein expressed in <i>E. coli</i>. Using a total of 894 clinical samples we showed that the rN-ELISA was able to detect IgG antibodies against SARS-CoV-2 with high sensitivity (97.5%) and specificity (96.3%) when compared to a commercial antibody test. After three external validation studies, we showed that the test accuracy was higher than 90%. The rN-ELISA IgG kit constitutes a convenient and specific method for the large-scale determination of SARS-CoV-2 antibodies in human sera with high reliability.</p>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":" ","pages":"100103"},"PeriodicalIF":1.7,"publicationDate":"2022-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9384617/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40433697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-08-01DOI: 10.1016/j.jcvp.2022.100085
N. Kojima , A. Roshani , J.D. Klausner
There have been reports that the Omicron variant of SARS-CoV-2 is milder and may resolve more quickly than earlier variants of SARS-CoV-2, like the Delta variant. Due to a dearth of studies on duration of PCR positivity for the Omicron variant, we studied this question in a cohort of routinely tested employees that work in a large laboratory. We found that there was no difference in duration of PCR positivity among those infected with the Omicron variant of SARS-CoV-2 versus earlier variants of SARS-CoV-2. That suggests in a clinical study that the increased infectiousness of Omicron might likely be due to factors related to viral and host cell interactions, rather than viral load or duration of infectivity, which has been suggested in immune escape studies.
{"title":"Duration of COVID-19 PCR positivity for Omicron vs earlier variants","authors":"N. Kojima , A. Roshani , J.D. Klausner","doi":"10.1016/j.jcvp.2022.100085","DOIUrl":"10.1016/j.jcvp.2022.100085","url":null,"abstract":"<div><p>There have been reports that the Omicron variant of SARS-CoV-2 is milder and may resolve more quickly than earlier variants of SARS-CoV-2, like the Delta variant. Due to a dearth of studies on duration of PCR positivity for the Omicron variant, we studied this question in a cohort of routinely tested employees that work in a large laboratory. We found that there was no difference in duration of PCR positivity among those infected with the Omicron variant of SARS-CoV-2 versus earlier variants of SARS-CoV-2. That suggests in a clinical study that the increased infectiousness of Omicron might likely be due to factors related to viral and host cell interactions, rather than viral load or duration of infectivity, which has been suggested in immune escape studies.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"2 3","pages":"Article 100085"},"PeriodicalIF":1.7,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9123744/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9077786","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-08-01DOI: 10.1016/j.jcvp.2022.100083
Don Bambino Geno S. Tai , Maryam Mahmood , Joseph D. Yao , John D. Zeuli , Ahmed Hamdi , Edison J. Cano Cevallos , Mary Jo Kasten
Background
Accuracy of screening tests is vital in the diagnosis of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) infection.
Objective
Our goal is to report false-positive serologic tests secondary to heterophile antibodies in a group of pork processing plant workers.
Methods
We conducted a case series study of seven pork processing plant workers referred to our clinic between 2017 and 2020 for a positive fourth-generation HIV test.
Results
All patients had undetectable HIV-1 and HIV-2 RNA viral load, ruling out HIV infection. Five patients had initial positive HBV serologies but were negative upon retesting with neutralizing antibodies or heterophile antibody binding reagent. Three patients presented with respiratory symptoms. After extensive workup, they were diagnosed with interstitial lung disease of unknown etiology. For patients who left the plant, their symptoms resolved, and serologic test results reverted to negative.
Conclusions
: Occupational exposure to pork meat products may elicit heterophile antibody development and yield false-positive serologic results for HIV and viral hepatitis. Clinicians should interpret serologic tests carefully together with other relevant patient history and molecular tests. Further investigation is warranted to determine the etiology, pathophysiology, and occupational link of the pneumonitis syndrome.
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Pub Date : 2022-08-01DOI: 10.1016/j.jcvp.2022.100091
Brian H.M. Sit , Kathy Hiu Laam Po , Yuk-Yam Cheung , Alan K. L. Tsang, Patricia K. L. Leung, J. Zheng, Alison Y. T. Lam, Edman T. K. Lam, Ken H. L. Ng, Rickjason C. W. Chan
<div><h3>Objectives</h3><p>The World Health Organization (WHO) had designated the SARS-CoV-2 lineage B.1.1.529 as the new Variant of Concern Omicron (VOC-Omicron) on 26<sup>th</sup> November 2021<sup>1</sup>. Real-time reverse transcription polymerase chain reaction (RT-PCR), single nucleotide polymorphisms (SNP) and whole genome sequencing (WGS) tests were widely employed to detect SARS-CoV-2 and its variant. Yet, the SARS-CoV-2 Omicron detection performance of commercial real-time RT-PCR platforms and SARS-CoV-2 spike SNP assays remain to be elucidated.</p></div><div><h3>Methods</h3><p>In the first part of this study, we evaluated the VOC-Omicron detection performance of three commercial RT-PCR sample-to-answer platforms i.e. Roche cobas® 6800/8800, Roche cobas® Liat®, and Cepheid GeneXpert® systems. The detection performances were compared to one commercial conventional real-time RT-PCR assay (TIB MOLBIOL LightMix Modular SARS and Wuhan CoV E-gene) and one in-house real-time RT-PCR assay targeting RNA-dependent RNA polymerase (RdRP) gene of SARS-CoV-2 in the WHO COVID-19 Reference Laboratory at Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, The Government of the Hong Kong Special Administrative Region. In the second part of this study, we evaluated the SNP detection performance of four TIB MOLBIOL melting curve-based assays (1. Spike S371L/S373P, 2. Spike E484A, 3. Spike E484K and 4. Spike N501Y) in clinical samples obtained from hospitalized COVID-19 patients in Hong Kong. The SNP results were compared to whole genome sequences generated by Illumina platform.</p></div><div><h3>Results</h3><p>The VOC-Omicron detection limits of three commercial sample-to-answer assays were tested to be ≤ 2.35 Log<sub>10</sub> dC/ml. The detection performances of the sample-to-answer platforms were comparable to the two tested conventional real-time RT-PCR assays. The test sensitivities of TIB MOLBIOL VirSNiP SARS-CoV-2 Spike S371L/S373P assay and the Spike E484A assays were 100% and 96.6% respectively and the test specificities of both assays were 100%. An aberrant melting peak at Tm 42-44°C was observed when the specimens with Omicron variant were tested with the TIB MOLBIOL VirSNiP SARS-CoV-2 Spike E484K assay. Notably, the TIB MOLBIOL VirSNiP SARS-CoV-2 Spike N501Y assay failed to detect the spike N501Y mutation of Omicron variant in the tested specimens.</p></div><div><h3>Conclusions</h3><p>The SARS-CoV-2 detection sensitivity of three commercial platforms, Roche cobas® 6800/8800, Roche cobas® Liat®, and Cepheid GeneXpert® systems were shown not to be impacted by the large number of mutations of VOC-Omicron. Also, the signature mutations i.e. Spike S371L/Spike S373P and Spike E484A in VOC-Omicron were correctly identified by the TIB MOLBIOL VirSNiP SARS-CoV-2 Spike S371L/S373P and VirSNiP SARS-CoV-2 Spike E484A assays. Unexpected findings including a shifted melting peak or absence of amplification curve/melti
{"title":"Detection of SARS-CoV-2 VOC-Omicron using commercial sample-to-answer real-time RT-PCR platforms and melting curve-based SNP assays","authors":"Brian H.M. Sit , Kathy Hiu Laam Po , Yuk-Yam Cheung , Alan K. L. Tsang, Patricia K. L. Leung, J. Zheng, Alison Y. T. Lam, Edman T. K. Lam, Ken H. L. Ng, Rickjason C. W. Chan","doi":"10.1016/j.jcvp.2022.100091","DOIUrl":"10.1016/j.jcvp.2022.100091","url":null,"abstract":"<div><h3>Objectives</h3><p>The World Health Organization (WHO) had designated the SARS-CoV-2 lineage B.1.1.529 as the new Variant of Concern Omicron (VOC-Omicron) on 26<sup>th</sup> November 2021<sup>1</sup>. Real-time reverse transcription polymerase chain reaction (RT-PCR), single nucleotide polymorphisms (SNP) and whole genome sequencing (WGS) tests were widely employed to detect SARS-CoV-2 and its variant. Yet, the SARS-CoV-2 Omicron detection performance of commercial real-time RT-PCR platforms and SARS-CoV-2 spike SNP assays remain to be elucidated.</p></div><div><h3>Methods</h3><p>In the first part of this study, we evaluated the VOC-Omicron detection performance of three commercial RT-PCR sample-to-answer platforms i.e. Roche cobas® 6800/8800, Roche cobas® Liat®, and Cepheid GeneXpert® systems. The detection performances were compared to one commercial conventional real-time RT-PCR assay (TIB MOLBIOL LightMix Modular SARS and Wuhan CoV E-gene) and one in-house real-time RT-PCR assay targeting RNA-dependent RNA polymerase (RdRP) gene of SARS-CoV-2 in the WHO COVID-19 Reference Laboratory at Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, The Government of the Hong Kong Special Administrative Region. In the second part of this study, we evaluated the SNP detection performance of four TIB MOLBIOL melting curve-based assays (1. Spike S371L/S373P, 2. Spike E484A, 3. Spike E484K and 4. Spike N501Y) in clinical samples obtained from hospitalized COVID-19 patients in Hong Kong. The SNP results were compared to whole genome sequences generated by Illumina platform.</p></div><div><h3>Results</h3><p>The VOC-Omicron detection limits of three commercial sample-to-answer assays were tested to be ≤ 2.35 Log<sub>10</sub> dC/ml. The detection performances of the sample-to-answer platforms were comparable to the two tested conventional real-time RT-PCR assays. The test sensitivities of TIB MOLBIOL VirSNiP SARS-CoV-2 Spike S371L/S373P assay and the Spike E484A assays were 100% and 96.6% respectively and the test specificities of both assays were 100%. An aberrant melting peak at Tm 42-44°C was observed when the specimens with Omicron variant were tested with the TIB MOLBIOL VirSNiP SARS-CoV-2 Spike E484K assay. Notably, the TIB MOLBIOL VirSNiP SARS-CoV-2 Spike N501Y assay failed to detect the spike N501Y mutation of Omicron variant in the tested specimens.</p></div><div><h3>Conclusions</h3><p>The SARS-CoV-2 detection sensitivity of three commercial platforms, Roche cobas® 6800/8800, Roche cobas® Liat®, and Cepheid GeneXpert® systems were shown not to be impacted by the large number of mutations of VOC-Omicron. Also, the signature mutations i.e. Spike S371L/Spike S373P and Spike E484A in VOC-Omicron were correctly identified by the TIB MOLBIOL VirSNiP SARS-CoV-2 Spike S371L/S373P and VirSNiP SARS-CoV-2 Spike E484A assays. Unexpected findings including a shifted melting peak or absence of amplification curve/melti","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"2 3","pages":"Article 100091"},"PeriodicalIF":1.7,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9213017/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40405655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-08-01DOI: 10.1016/j.jcvp.2022.100100
Sung‐Soo Park , Duck‐Jin Hong , Katrine K Gatchalian , Hye-Young Oh
Introduction
False-positive inconclusive polymerase chain reaction (PCR) results against severe acute respiratory syndrome coronavirus 2 were not low and have potentially harmful effects. We aimed to find parameters to differentiate positive cases from false-positive ones, and suggest an optimal scheme and follow-up period for inconclusive results.
Methods
Cases with inconclusive PCR tests among healthcare personnel from February 2020 to June 2021 were classified as confirmed positive, clinically positive, and clinically negative groups, which were compared. The diagnostic accuracy of follow-up tests and composites of clinical and laboratory data were analyzed.
Results
Symptoms, contact history, and lower cycle threshold of the N gene were more common in the COVID-19 positive group. The scoring schemes combining symptom and contact history with follow-up PCR results had higher sensitivities than the PCR tests only modality. Follow-up tests up to 5 days combined with symptoms and contact history could discriminate between positive and negative cases.
Conclusion
A follow-up PCR test up to day 5 with clinical features might predict positivity and shorten the quarantine period in most healthcare personnel.
{"title":"Follow-up COVID-19 PCR result up to day 5 with clinical features predicts positivity for inconclusive results","authors":"Sung‐Soo Park , Duck‐Jin Hong , Katrine K Gatchalian , Hye-Young Oh","doi":"10.1016/j.jcvp.2022.100100","DOIUrl":"10.1016/j.jcvp.2022.100100","url":null,"abstract":"<div><h3>Introduction</h3><p>False-positive inconclusive polymerase chain reaction (PCR) results against severe acute respiratory syndrome coronavirus 2 were not low and have potentially harmful effects. We aimed to find parameters to differentiate positive cases from false-positive ones, and suggest an optimal scheme and follow-up period for inconclusive results.</p></div><div><h3>Methods</h3><p>Cases with inconclusive PCR tests among healthcare personnel from February 2020 to June 2021 were classified as confirmed positive, clinically positive, and clinically negative groups, which were compared. The diagnostic accuracy of follow-up tests and composites of clinical and laboratory data were analyzed.</p></div><div><h3>Results</h3><p>Symptoms, contact history, and lower cycle threshold of the N gene were more common in the COVID-19 positive group. The scoring schemes combining symptom and contact history with follow-up PCR results had higher sensitivities than the PCR tests only modality. Follow-up tests up to 5 days combined with symptoms and contact history could discriminate between positive and negative cases.</p></div><div><h3>Conclusion</h3><p>A follow-up PCR test up to day 5 with clinical features might predict positivity and shorten the quarantine period in most healthcare personnel.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"2 3","pages":"Article 100100"},"PeriodicalIF":1.7,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9308491/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40572928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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