scholarly journals Field accuracy of HIV rapid diagnostic tests for blood donors screening, Bukavu, Eastern Democratic Republic of the Congo

2018 ◽  
Vol 12 (06) ◽  
pp. 471-476
Author(s):  
Théophile Mitima Kashosi ◽  
Céléstin Bisangamo Kyambikwa ◽  
Philémon Mbarabara Mulongo ◽  
Jean Bisimwa Nachega
Keyword(s):  
Diagnostic Tests ◽  
Blood Donors ◽  
Democratic Republic ◽  
Point Of Care ◽  
Kappa Statistic ◽  
Rapid Diagnostic Tests ◽  
Cohen’S Kappa ◽  
Cohen's Kappa ◽  
Republic Of The Congo ◽  
Hiv 1

Introduction: Rapid diagnostic tests (RDTs) are widely used for point-of-care. point-of-care diagnosis of HIV infection in resource-limited settings. However, there are no data about their field diagnostic performance in Eastern Democratic Republic of the Congo (DRC), especially in the context of blood banks screening for transfusion safety purpose. Methodology: Blood specimens were collected from blood donors in Bukavu, Eastern DRC, from May the 1st to June the 30th, 2015, to evaluate the accuracy of Alere Determine HIV-1/2, Trinity Biotech Uni‑Gold HIV, and DoubleCheckGold Ultra HIV 1& 2 compared to the laboratory-based 4th generation ELISA apDia HIV Ag/Ab assay. Sensitivity, specificity, positive and negative predictive values, and related 95% confidence intervals were calculated using MedCalc statistical software version 15.1. Reliability was evaluated using Cohen’s Kappa Statistic, κ. Results: Among 312 participants who provided blood bags, 96/312 (30.7%) were female and the mean age (SD) was 31.7 years (± 8.1years). Sensitivity for the three tests was 57.1% (95% CI: 18.4-90.1). The specificity was 99.7% (95% CI: 18.4-90.1) for Alere Determine HIV 1/2, 100% (95% CI: 98.8-100.0) for Uni-Gold HIV, and (100% (95% CI: 98.8-100.0) for DoubleCheckGold Ultra HIV 1&2. Cohen’s Kappa Statistic showed moderate agreement between the 4th generation ELISA apDia HIV Ag/Ab and RDTs Alere Determine HIV 1/2 and Uni-Gold HIV (κ = 0.66; 95% CI: 0.55- 0.76) but good agreement for DoubleCheckGold Ultra HIV1&2 (κ = 0.72; 95% CI: 0.61 – 0.82). Conclusions: Compared to the laboratory-based ELISA apDia HIV Ag/Ab assay, the currently used 3rd generation HIV RDTs showed poor field accuracy results in a context of blood donors screening. These data support the need for 4th generation Ag-Ab RDTs in transfusion blood qualification.

scholarly journals Clinical Evaluation of QuickNaviTM-Ebola in the 2018 Outbreak of Ebola Virus Disease in the Democratic Republic of the Congo

Viruses ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 589 ◽  
Author(s):  
Sheila Makiala ◽  
Daniel Mukadi ◽  
Anja De Weggheleire ◽  
Shino Muramatsu ◽  
Daisuke Kato ◽  
...  
Keyword(s):  
West Africa ◽  
Diagnostic Tests ◽  
Ebola Virus ◽  
Democratic Republic ◽  
Virus Disease ◽  
Point Of Care ◽  
Rapid Diagnostic Tests ◽  
Ebola Virus Disease ◽  
Blood Samples ◽  
Republic Of The Congo

The recent large outbreaks of Ebola virus disease (EVD) in West Africa and the Democratic Republic of the Congo (DRC) have highlighted the need for rapid diagnostic tests to control this disease. In this study, we clinically evaluated a previously developed immunochromatography-based kit, QuickNaviTM-Ebola. During the 2018 outbreaks in DRC, 928 blood samples from EVD-suspected cases were tested with QuickNaviTM-Ebola and the WHO-approved GeneXpert. The sensitivity and specificity of QuickNaviTM-Ebola, estimated by comparing it to GeneXpert-confirmed cases, were 85% (68/80) and 99.8% (846/848), respectively. These results indicate the practical reliability of QuickNaviTM-Ebola for point-of-care diagnosis of EVD.

scholarly journals Analysis of false-negative rapid diagnostic tests for symptomatic malaria in the Democratic Republic of the Congo

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jonathan B. Parr ◽  
Eddy Kieto ◽  
Fernandine Phanzu ◽  
Paul Mansiangi ◽  
Kashamuka Mwandagalirwa ◽  
...  
Keyword(s):  
Whole Genome Sequencing ◽  
Genome Sequencing ◽  
Diagnostic Tests ◽  
Democratic Republic ◽  
False Negative ◽  
Rapid Diagnostic Tests ◽  
Whole Genome ◽  
Symptomatic Malaria ◽  
Asymptomatic Children ◽  
Republic Of The Congo

AbstractThe majority of Plasmodium falciparum malaria diagnoses in Africa are made using rapid diagnostic tests (RDTs) that detect histidine-rich protein 2. Increasing reports of false-negative RDT results due to parasites with deletions of the pfhrp2 and/or pfhrp3 genes (pfhrp2/3) raise concern about existing malaria diagnostic strategies. We previously identified pfhrp2-negative parasites among asymptomatic children in the Democratic Republic of the Congo (DRC), but their impact on diagnosis of symptomatic malaria is unknown. We performed a cross-sectional study of false-negative RDTs in symptomatic subjects in 2017. Parasites were characterized by microscopy; RDT; pfhrp2/3 genotyping and species-specific PCR assays; a bead-based immunoassay for Plasmodium antigens; and/or whole-genome sequencing. Among 3627 symptomatic subjects, 427 (11.8%) had RDT-/microscopy + results. Parasites from eight (0.2%) samples were initially classified as putative pfhrp2/3 deletions by PCR, but antigen testing and whole-genome sequencing confirmed the presence of intact genes. 56.8% of subjects had PCR-confirmed malaria. Non-falciparum co-infection with P. falciparum was common (13.2%). Agreement between PCR and HRP2-based RDTs was satisfactory (Cohen’s kappa = 0.66) and superior to microscopy (0.33). Symptomatic malaria due to pfhrp2/3-deleted P. falciparum was not observed. Ongoing HRP2-based RDT use is appropriate for the detection of falciparum malaria in the DRC.

scholarly journals Diagnostic Accuracy of CareStart™ Malaria HRP2 and SD Bioline Pf/PAN for Malaria in Febrile Outpatients in Varying Malaria Transmission Settings in Cameroon

Diagnostics ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. 1556
Author(s):  
Innocent Mbulli Ali ◽  
Akindeh Mbuh Nji ◽  
Jacob Chefor Bonkum ◽  
Marcel Nyuylam Moyeh ◽  
Guenang Kenfack Carole ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Malaria Transmission ◽  
Diagnostic Tests ◽  
Diagnostic Performance ◽  
District Hospital ◽  
Rapid Diagnostic Tests ◽  
Cohen’S Kappa ◽  
Cohen's Kappa ◽  
Malaria Rapid Diagnostic Tests ◽  
Catholic Hospital

Background: There was an increase in the number of malaria cases in Cameroon in 2018 that could reflect changes in provider practice, despite effective interventions. In this study, we assessed the diagnostic performance of two malaria rapid diagnostic tests (mRDTs) for diagnostic confirmation of suspected cases of malaria in public and private health facilities in two malaria transmission settings in Cameroon. Methods: We evaluated the diagnostic performance of CareStart pf and SD Bioline Pf/PAN mRDT and compared these parameters by RDT type and transmission setting. Nested PCR and blood film microscopy were used as references. The chi square test was used for independent sample comparisons, while the McNemar’s test was used to test for the dependence of categorical data in paired sample testing. A p < 0.05 was considered significant in all comparisons. The R (v.4.0.2) software was used for analyses. Results: A total of 1126 participants consented for the study in the four sites. The diagnostic accuracy of the CareStart Pf mRDT was 0.93.6% (0.911–0.961) in Yaoundé, 0.930% (0.90–0.960) in Ngounso, 0.84% (0.794–0.891) in St Vincent Catholic Hospital Dschang and 0.407 (0.345–0.468) in Dschang district hospital. For SD Bioline Pf/PAN the accuracy was 0.759 (0.738–0.846) for St Vincent Catholic Hospital Dschang and 0.426 (0.372–0.496) for the Dschang district hospital. The accuracy was slightly lower in each case but not statistically different when PCR was considered as the reference. The likelihood ratios of the positive and negative tests were high in the high transmission settings of Yaoundé (10.99 (6.24–19.35)) and Ngounso (14.40 (7.89–26.28)) compared to the low transmission settings of Dschang (0.71 (0.37–1.37)) and St Vincent Catholic hospital (7.37 (4.32−12.59)). There was a high degree of agreement between the tests in Yaoundé (Cohen’s Kappa: 0.85 ± 0.05 (0.7–0.95)) and Ngounso (Cohen’s Kappa: 0.86 ± 0.05 (0.74, 0.97)) and moderate agreement in St Vincent hospital Dschang (k: 0.58 ± 0.06 (0.44–0.71)) and poor agreement in the District Hospital Dschang (Cohen’s Kappa: −0.11 ± 0.05 (−0.21–0.01)). The diagnostic indicators of the SD Bioline Pf/PAN were slightly better than for CareStart Pf mRDT in St Vincent Catholic hospital Dschang, irrespective of the reference test. Conclusions: Publicly procured malaria rapid diagnostic tests in Cameroon have maintained high accuracy (91–94%) in the clinical diagnosis of malaria in high malaria transmission regions of Cameroon, although they failed to reach WHO standards. We observed an exception in the low transmission region of Dschang, West region, where the accuracy tended to be lower and variable between facilities located in this town. These results underscore the importance of the routine monitoring of the quality and performance of malaria RDTs in diverse settings in malaria endemic areas.

scholarly journals Postmortem Surveillance for Ebola Virus Using OraQuick Ebola Rapid Diagnostic Tests, Eastern Democratic Republic of the Congo, 2019–2020

2022 ◽  
Vol 28 (2) ◽  
Author(s):  
Daniel Mukadi-Bamuleka ◽  
Yibayiri Osee Sanogo ◽  
Junior Bulabula-Penge ◽  
Maria E. Morales-Betoulle ◽  
Patrice Fillon ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Ebola Virus ◽  
Democratic Republic ◽  
Rapid Diagnostic Tests ◽  
Republic Of The Congo

scholarly journals Voice-Based Screening For SARS-CoV-2 Exposure In Cardiovascular Clinics

2021 ◽  
Author(s):  
Abhinav Sharma ◽  
Emily Oulousian ◽  
Jiayi Ni ◽  
Renato Lopes ◽  
Matthew Pellan Cheng ◽  
...  
Keyword(s):  
Healthcare Provider ◽  
Clinical Care ◽  
Health Centre ◽  
Healthcare Delivery ◽  
Signs And Symptoms ◽  
Kappa Statistic ◽  
Cohen’S Kappa ◽  
Cohen's Kappa ◽  
Mcgill University ◽  
Strongly Agree

Abstract Aims Artificial intelligence (A.I) driven voice-based assistants may facilitate data capture in clinical care and trials; however, the feasibility and accuracy of using such devices in a healthcare environment are unknown. We explored the feasibility of using the Amazon Alexa (‘Alexa’) A.I. voice-assistant to screen for risk-factors or symptoms relating to SARS-CoV-2 exposure in quaternary care cardiovascular clinics. Methods We enrolled participants to be screened for signs and symptoms of SARS-CoV-2 exposure by a healthcare provider and then subsequently by the Alexa. Our primary outcome was interrater reliability of Alexa to healthcare provider screening using Cohen’s Kappa statistic. Participants rated the Alexa in a post-study survey (scale of 1 to 5 with 5 reflecting strongly agree). This study was approved by the McGill University Health Centre ethics board. Results We prospectively enrolled 215 participants. The mean age was 46 years (17.7 years standard deviation [SD]), 55% were female, and 31% were French speakers (others were English). In total, 645 screening questions were delivered by Alexa. The Alexa mis-identified one response. The simple and weighted Cohen’s kappa statistic between Alexa and healthcare provider screening was 0.989 (95% CI: 0.982, 0.997) and 0.992 (955 CI 0.985, 0.999) respectively. The participants gave an overall mean rating of 4.4 (out of 5, 0.9 SD). Conclusion Our study demonstrates the feasibility of an A.I. driven multilingual voice-based assistant to collect data in the context of SARS-CoV-2 exposure screening. Future studies integrating such devices in cardiovascular healthcare delivery and clinical trials are warranted. Registration https://clinicaltrials.gov/ct2/show/NCT04508972

scholarly journals Point-of-Care Measurement of Activated Clotting Time for Cardiac Surgery as measured by the Hemochron Signature Eliteand the Abbott i-STAT: Agreement, Concordance, and Clinical Reliability

2019 ◽  
Author(s):  
Daniel Dirkmann ◽  
Elisabeth Nagy ◽  
Martin Walter Britten ◽  
Juergen Peters
Keyword(s):  
Cardiac Surgery ◽  
Linear Correlation ◽  
Point Of Care ◽  
Clotting Time ◽  
Cohen’S Kappa ◽  
Cohen's Kappa ◽  
Activated Clotting Time ◽  
Target Values ◽  
Heparin Anticoagulation ◽  
Parallel Measurements

Abstract Background: Since inadequate heparin anticoagulation and insufficient reversal can result in complications during cardiopulmonary bypass (CPB) surgery, heparin anticoagulation monitoring by point-of-care (POC) activated clotting time (ACT) measurements is essential for CPB initiation, maintainance, and anticoagulant reversal. However, concerns exist regarding reproducibility of ACT assays and comparability of devices. Methods: We evaluated the agreement of ACT assays using four parallel measurements performed on two commonly used devices each (i.e., two Hemochron Signature Elite (Hemochron) and two Abbott i-STAT (i-STAT) devices, respectively). Blood samples from 30 patients undergoing cardiac surgery on CPB were assayed at specified steps (baseline, after heparin administration, after protamine administration) with four parallel measurements (two of each device type) using commercial Kaolin activated assays provided by the respective manufactures. Measurements were compared between identical and different device types using linear regression, Bland-Altman analyses, and calculation of Cohen’s kappa coefficient. Results: Parallel i-STAT ACTs demonstrated a good linear correlation (r=0.985). Bias, as determined by Bland-Altman analysis, was low (-3.8s; 95% limits of agreement (LOA): -77.8 -70.2s), and Cohen’s Kappa demonstrated good agreement (kappa=0.809). Hemochron derived ACTs demonstrated worse linear correlation (r=0.782), larger bias with considerably broader LOA (-13.14s; 95%LOA:-316.3-290s), and lesser concordance between parallel assays (kappa=0.554). Although demonstrating a fair linear correlation (r=0.815), parallel measurements on different ACT-devices showed large bias (-20s; 95% LOA: -290-250s) and little concordance (kappa=0.368). Overall, disconcordant results according to clinically predefined target values were more frequent with the Hemochron than i-STAT. Furthermore, while discrepancies in ACT between two parallel iSTAT assays showed little or no clinical relevance, deviations from parallel Hemochron assays and iSTAT versus Hemochron measurements revealed marked and sometimes clinically critical deviations. Conclusion: Currently used ACT point-of-care devices cannot be used interchangeably. Furthermore, our data question the reliability of the Hemochron in assessing adequacy of heparin anticoagulation monitoring for CPB.

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