Rapid Point Of Care Test Research Articles

Point-of-Care diagnostic of SARS-CoV-2: knowledge, attitudes, and perceptions (KAP) of medical workforce in Italy.

Introduction.The present study aims to characterize knowledge, attitudes and beliefs in a sample of medical professionals towards point-of-care (POC) rapid tests for SARS-CoV-2 in Italy (April 2020).Material and Methods.A total of 561 professionals (42.6% males, 26.9% ≥ 50-year-old) compiled a specifically designed web questionnaire on characteristics of POC rapid tests. They were asked whether they would change their daily practice and make clinical decisions according to POC tests. Multivariate odds ratios (aOR) for predictors of propensity towards the aforementioned behavioral outcomes were calculated through regression analysis.Results.Overall, only 51.9% knew the official recommendations of the Italian Health Authorities for POC tests, while 26.0% of respondents considered POC tests for COVID-19 highly reliable. Still, 40.3% of respondents would change their daily practice because of such tests, and 38.5% would make clinical decisions based on their results. Knowledge of POC tests’s sensitivity and specificity was not associated with the assessed behavioral outcomes: main positive effectors were: perceived reliability and usefulness of rapid tests, acknowledging the existence of official recommendations, understanding the limited clinical implications of POC tests, and working as occupational physicians were characterized as negative effectors.Conclusions.Propensity of sampled professionals towards POC tests for COVID-19 was diffusely unsatisfying. While actual understanding of accuracy of such tests was not a main effector of propensity, previous experiences with other POC tests in daily practice, particularly among occupational physicians may have impaired overall acceptance of such instruments. (www.actabiomedica.it)

Evaluation of three commercialized rapid point-of-care tests for detection of anti-hepatitis C virus antibodies in Burkina Faso

This study aimed to evaluate the diagnostic performance of commercially rapid point-of-care (POC) tests used for HCV antibodies detection. This is a case-control study conducted in Ouagadougou between December 2014 and January 2015. Three POC for HCV antibodies detection (SD Bioline HCV test®, Anti-HCV dipstick® and First response® HCV card test) marketed in Burkina Faso were evaluated. Architect anti-HCV assay and ImmunoComb® II HCV were combined and used as a reference test. All three tests were evaluated with a panel of 62 anti-HCV positive sera and 62 anti-HCV negative sera. The tests performance was calculated using the software OpenEpi. The three rapid POC tests had a specificity of 100% (95% CI: 94.17-100). However, the sensitivities were 33.87% (95% CI: 23.34-46.28) for the SD Bioline HCV test®, 41.94% (95% CI: 30.48-54.33%) for Anti-HCV dipstick® and 45.16% (95%CI: 33.42-57.47%) for First response® HCV card test. The tests evaluated in this study had good specificity but poor sensitivity for the HCV antibodies detection in Burkina Faso. The surveillance of HCV rapid POC tests through the validation of their accuracy in the local context before their approval must be strengthened. Key words: Hepatitis C virus, point-of-care, diagnostic test.

1290. Community Screening and Education for HIV and Hepatitis C (HCV) infection in South Texas with Rapid Point of Care Testing and a Mobile Phone Application (app)

BackgroundHIV and HCV infection cause considerable morbidity and mortality if untreated. The southern United States has the highest burden of new HIV diagnoses nationwide. Approximately 60% of hepatocellular carcinoma (HCC) in the United States is due to HCV. HCC incidence rates are the fastest growing among all cancers in Texas (TX). We aimed to use community screening events to provide additional diagnostic opportunities and surveillance data for HIV/HCV and to evaluate an HIV/HCV app to optimize public health education and prevention.MethodsTwo community HIV/HCV screening/education events occurred in April 2019 in the border city of Laredo, TX (at a community park) and San Antonio, TX (on a university campus). Those screened for HIV/HCV using point of care rapid tests completed a demographic and risk factor questionnaire. HIV/HCV education was offered to attendees via an app with a teach-back feature to assess short-term knowledge gains in specific areas: HIV and HCV cure, body organ impacted by HCV, HCV transmission, HCV symptoms.ResultsAttendees: Laredo event—approximately 260 people; San Antonio event approximately 100 people. 60 people were screened for HIV and HCV. 77% were Hispanic, 63% were female, 68% were 18–25 years old, 63% reported not having a primary care provider. One HCV seroreactive case was identified and linked to care. The most commonly reported risk factors were having tattoos (43%) and body piercing (37%). Other risk factors included street drug use (12%), home finger stick blood checks (12%), dental surgery outside the United States (12%). Fifty-three people utilized the HIV/HCV education app. 91% correctly identified that HIV cannot be cured, 87% correctly identified that HCV impacts the liver and that a test can confirm HCV infection. 81% correctly identified how HCV can be transmitted and 79% corrected identified that HCV can be cured. The app was rated 4.8/5, as “very useful” on a Likert scale.ConclusionFeatures of those screened included not being engaged in primary care, having risk factors for both HCV and HIV infection and the majority being young adults. The HIV/HCV mobile phone app was an acceptable education tool for those who utilized it. Appropriately developed and implemented apps can be effective in teaching key knowledge points about HIV/HCV infection.Disclosures All authors: No reported disclosures.

Application of new host biomarker profiles in quantitative point-of-care tests facilitates leprosy diagnosis in the field.

BackgroundTransmission of Mycobacterium leprae, the pathogen causing leprosy, is still persistent. To facilitate timely (prophylactic) treatment and reduce transmission it is vital to both early diagnose leprosy, and identify infected individuals lacking clinical symptoms. However, leprosy-specific biomarkers are limited, particularly for paucibacillary disease. Therefore, our objective was to identify new biomarkers for leprosy and assess their applicability in point-of-care (POC) tests.MethodsUsing multiplex-bead-arrays, 60 host-proteins were measured in a cross-sectional approach in 24-h whole blood assays (WBAs) collected in Bangladesh (79 patients; 54 contacts; 51 endemic controls (EC)). Next, 17 promising biomarkers were validated in WBAs of a separate cohort (55 patients; 27 EC). Finally, in a third cohort (36 patients; 20 EC), five candidate markers detectable in plasma were assessed for application in POC tests.FindingsThis study identified three new biomarkers for leprosy (ApoA1, IL-1Ra, S100A12), and confirmed five previously described biomarkers (CCL4, CRP, IL-10, IP-10, αPGL-I IgM). Overnight stimulation in WBAs provided increased specificity for leprosy and was required for IL-10, IL-1Ra and CCL4. The remaining five biomarkers were directly detectable in plasma, hence suitable for rapid POC tests. Indeed, lateral flow assays (LFAs) utilizing this five-marker profile detected both multi- and paucibacillary leprosy patients with variable immune responses.InterpretationApplication of novel host-biomarker profiles to rapid, quantitative LFAs improves leprosy diagnosis and allows POC testing in low-resource settings. This platform can thus aid diagnosis and classification of leprosy and also provides a tool to detect M.leprae infection in large-scale contact screening in the field.

Response: Re: Impact of a Rapid Point of Care Test for Influenza on Guideline Consistent Care and Antibiotic Use

To the Editor: We thank Yasri and Wiwanitkit for their response regarding our publication on “Impact of a Rapid Point of Care Test for Influenza on Guideline Consistent Care and Antibiotic Use.”[1][1] A cost-effective point of care test is necessary to increase guideline consistency of care.

Sero-prevalence and Risk Factors for Hepatitis A Virus Infection among Pregnant Women at the Samandin Medical Center, Ouagadougou, Burkina Faso

Aims: This study determined prevalence and possible risk factors associated with HAV infection and compared Immunochromatography (IgG) rapid point of care test with standard ELISA test for diagnosis.
 Study Design: Cross sectional epidemiological survey.
 Place and duration of Study: The study was carried out at the Samandin Medical Center (Ouagadougou, Burkina Faso), from July 2017 to December 2017.
 Methodology: A total of 180 pregnant women were recruited at the Samandin Medical Center. Anti-HAV IgM and IgG detection tests were performed using AccuDiag™ HAV ELISA kit (Calabasas, CA, USA) and SD BIOLINE HAV IgG/IgM Rapid Diagnostic Test (Gyeonggi-do, Korea).
 Results: IgG anti-HAV antibodies (AccuDiag Elisa) were found with a prevalence of 88.9% (160/180) and Anti-HAV IgM were 1.1% (2/180). Of the 160 AccuDiag HAV IgG positive samples, 44.4% (80/180) tested positive using SD BIOLINE Diagnostics HAV IgG. Regarding risk factors, 86.9% (86/99) of the IgG positive women were illiterate; 90.7% (39/43) lived mostly in peripheral areas; 89.2% (74/83) were household workers and 88.6% (93/105) used fountain water.
 Conclusion: Our results demonstrated poor agreement between the assays tested, which are consistent with previous reports demonstrating significant variability between HAV ELISA and RDT HAV. Moreover, the detection of HAV specific IgM antibodies in two asymptomatic pregnant women signaled the current circulation of HAV in this area.

Highly Sensitive Lab on a Chip (LOC) Immunoassay for Early Diagnosis of Respiratory Disease Caused by Respirable Crystalline Silica (RCS).

Respirable crystalline silica (RCS) produced in mining and construction industries can cause life-threatening diseases such as silicosis, lung cancer, and chronic obstructive pulmonary disease (COPD). These diseases could be more effectively treated and prevented if RCS-related biomarkers were identified and measured at an early stage of disease progression, which makes development of a point of care test (POCT) platform extremely desirable for early diagnosis. In this work, a new, highly sensitive lab on a chip (LOC) immunoassay has been designed, developed, and characterized for tumor necrosis factor α (TNF-α), a protein biomarker that causes lung inflammation due to RCS exposure. The designed LOC device is composed of four reservoirs for sample, enzyme conjugated detection antibody, wash buffer, and chemiluminescence substrate in liquid form, along with three spiral reaction chambers for test, positive control, and negative control. All reservoirs and spiral microchannels were connected in series and designed to perform sequential delivery of immunoassay reagents with minimal user intervention. The developed LOC measured TNF-α concentrations as low as 16 pg/mL in plasma from RCS-exposed rats and also had a limit of detection (LOD) of 0.5 pg/mL in spiked artificial serum. In addition, the analysis time was drastically reduced to about 30 min, as opposed to hours in conventional methods. Successful implementation of a highly sensitive, chemiluminescence-based immunoassay on a preloaded LOC with proper quality control, as reported in this work, can pave the way toward developing a new rapid POCT platform for in-field clinical diagnosis.

Seasonal dengue surge: Providers⬨tm) perceptions about the impact of dengue on patient volume, staffing and use of point of care testing in Indian emergency departments

BackgroundGlobal health emergencies, such as from diseases like dengue fever, can lead to rapid surges in visits to emergency departments. The objective of our study was to evaluate the impact of dengue on factors that could impact emergency department flow, including patient volume and staffing, on Indian emergency departments. MethodsThis was a prospective cohort study of Indian emergency providers. Respondents were queried via online survey about a number of domains including practice environment, use of rapid testing, changes in ED volume and ED staffing adjustments occurring during dengue season. Data was analyzed using multivariate analysis. ResultsWe had a total of 210 respondents to our online survey. Less than half of respondents reported that their institutions used rapid point of care testing. When asked how dengue impacted ED flow, the most common response was that dengue increased the total number of ED visits (84%). Despite this increase, only about 32% of respondents reported that their institutions increased hospital staffing. In multivariate analysis, respondents at hospitals that experienced ED visit surges over 40% of baseline were more likely to also report that their institutions also increased staffing during this time (OR 3.28, 95% CI 1.44–7.46). ConclusionsOur study shows that despite increases in visits during dengue season, ED providers noted that their EDs did not respond with staffing increases. More research is needed to better understand how emergency departments can adjust to dengue to provide optimal care for patients in India.

Impact of a Rapid Point of Care Test for Influenza on Guideline Consistent Care and Antibiotic Use.

Rapid influenza diagnostic tests that detect the presence of viral antigens are currently used throughout the United States but have poor sensitivity. The objective of this study was to identify if the use of a new highly accurate rapid point of care test would significantly increase the likelihood of guideline consistent care. We prospectively recruited 300 students at a university health clinic who presented with cough and 1 influenza-like illness symptom between December 2016 and February 2017 to receive care guided by a rapid polymerase chain reaction (PCR) test. Of the 300 patients receiving the PCR test, 264 had complete medical records and were compared to 771 who received usual care. We used a logistic regression model to identify whether PCR guided care was associated with guideline consistent care, based on the appropriate use of oseltamivir and antibiotics. We also assessed whether PCR guided care decreased the likelihood of return visits within 2 weeks by patients. Logistic regression revealed that the odds of receiving guideline supported care did not significantly increase for patients who received PCR guided care (adjusted odds ratio [aOR], 1.24; 95% CI, 0.83-1.88). It significantly decreased the likelihood of an antibiotic prescription (aOR, 0.61; 95% CI, 0.40-0.94), increased the likelihood of receiving oseltamivir (aOR, 1.57; 95% CI, 1.09-2.28), and decreased the likelihood of return visit within 2 weeks (aOR, 0.19; 95% CI, 0.04-0.81). The use of a rapid PCR test did not significantly improve the likelihood of guideline consistent care. However, independent of test outcome, patients who received the test were more likely to receive an antiviral and less likely to receive an antibiotic or have a return visit within 2 weeks.

Where are the positives? HIV testing in sub-Saharan Africa in the era of test and treat.

Where are the positives? HIV testing in sub-Saharan Africa in the era of test and treat.

P153 Quantum blue anti-adalimumab: development and evaluation of a point of care rapid test for measuring anti-adalimumab antibodies in human serum

P153 Quantum blue anti-adalimumab: development and evaluation of a point of care rapid test for measuring anti-adalimumab antibodies in human serum

P202 Quantum blue anti-infliximab: development and evaluation of a point of care rapid test for measuring anti-infliximab antibodies in human serum

P202 Quantum blue anti-infliximab: development and evaluation of a point of care rapid test for measuring anti-infliximab antibodies in human serum

Laboratory evaluation of four HIV/syphilis rapid diagnostic tests

BackgroundSexually transmitted infections, such as HIV and syphilis, are one of the major health care problems worldwide, especially in low- and middle income countries. HIV screening programmes have been widely used for many years. The introduction of rapid point-of-care tests (RDTs) that can detect both HIV and syphilis, using one single blood specimen, would be a promising tool to integrate the detection of syphilis into HIV programmes and so improve the accessibility of syphilis testing and treatment.MethodsAs part of the World Health Organization pre-qualification of in vitro diagnostics assessment, the laboratory performance of four dual HIV-Syphilis rapid diagnostic tests (SD Bioline HIV/Syphilis Duo, DPP HIV-Syphilis Assay, Multiplo Rapid TP/HIV Antibody Test and Insti Multiplex HIV-1/HIV-2/Syphilis Antibody Test) was assessed using a well characterized multiregional panel of stored sera specimens.ResultsIn total 400 specimens were tested with each assay, resulting in excellent sensitivities and specificities for HIV, ranging from 99.5 to 100% and from 93.5 to 99.5%, respectively. Results obtained for the Treponema pallidum antibodies were lower, with the lowest sensitivity of 73.5% for Multiplo and the highest of 87% for SD Bioline. Specificities ranged from 99.0 to 100%.ConclusionAlthough these results suggest that the tests could further improve in accuracy in detection of treponemal antibodies, their introduction into screening programmes to increase the accessibility of HIV/Syphilis diagnosis and treatment for difficult to reach populations in the world is promising.

A review of the atomoRapid HIV self-testing device: an acceptable and easy alternative to facilitate HIV testing

ABSTRACT Introduction:HIV testing is the gateway to both HIV prevention and treatment, and increased HIV testing and linkage to services is vital for an effective HIV response. HIV testing has progressed significantly from a lengthy laboratory process conducted by specialist medical staff to rapid point of care testing performed by trained lay staff. Despite HIV testing services being widely available, testing rates remain suboptimal among young people and men. Alternative delivery strategies that complement conventional testing services are needed to reach these priority groups. Areas covered:This article reviewed the AtomoRapid HIV self-testing (HIVST) device as an innovative alternative to conventional testing. Expert commentary:HIVST complements traditional HIV testing options and can be used to overcome major barriers to testing by catering for testing outside of conventional settings and by allowing individuals to test themselves privately, and at their own discretion and frequency. We conclude that the high sensitivity, specificity, acceptability, usability, and fidelity of this device makes it an appropriate option for the enhancement of HIV testing strategies for harder to reach populations, such as young people and men.

A retrospective data analysis of Legionella pneumophila diagnostic procedures and their impact on patients' management: the experience of a rapid point-of-care test

We compare a conventional and a rapid point of care test (POCT) for the diagnosis of Legionella pneumophila, considering various performance criteria. We used data of patients with positive test for L. pneumophila (confirmed cases), registered by the microbiology laboratories of two hospitals in Crete, Greece. Hospital A adopts a conventional, indirect fluorescent-antibody technique and Hospital B uses a urinary antigen POCT. The mean laboratory turnaround time was 4.45 days for the conventional test and 0.11 days for POCT. A total of 24 laboratory positive cases (11 inpatients, 13 outpatients) were identified out of 905 samples taken from 751 people. The mean daily hospitalisation cost per inpatient was €79.86 for Hospital B and €127.45 for Hospital A; for the latter a much higher antibiotic treatment cost/patient was recorded. The analysis suggests that a rapid POCT for L. pneumophila could significantly decrease time to diagnosis, improve treatment and reduce hospitalisation charges.

A retrospective data analysis of Legionella pneumophila diagnostic procedures and their impact on patients' management: the experience of a rapid point-of-care test

We compare a conventional and a rapid point of care test (POCT) for the diagnosis of Legionella pneumophila, considering various performance criteria. We used data of patients with positive test for L. pneumophila (confirmed cases), registered by the microbiology laboratories of two hospitals in Crete, Greece. Hospital A adopts a conventional, indirect fluorescent-antibody technique and Hospital B uses a urinary antigen POCT. The mean laboratory turnaround time was 4.45 days for the conventional test and 0.11 days for POCT. A total of 24 laboratory positive cases (11 inpatients, 13 outpatients) were identified out of 905 samples taken from 751 people. The mean daily hospitalisation cost per inpatient was €79.86 for Hospital B and €127.45 for Hospital A; for the latter a much higher antibiotic treatment cost/patient was recorded. The analysis suggests that a rapid POCT for L. pneumophila could significantly decrease time to diagnosis, improve treatment and reduce hospitalisation charges.

PO645 Use of Rapid Point of Care Testing For Diagnosis of Group A Strep Throat In Western Tanzania

It is unclear how guidelines panelists discuss and consider factors (criteria) that are formally and not formally included in the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. To describe the use of decision criteria, we explored how panelists adhered to GRADE criteria and sought to identify any emerging non-GRADE criteria when the panelists used the Evidence to Decision (EtD) framework as part of GRADE application.We used conventional and summative qualitative analyses to identify themes emerging from face-to-face, panel meeting discussions. Forty-eight members from 12 countries participated in the development of five guidelines for the management of venous thromboembolism by the American Society of Hematology.Ten themes corresponded to the GRADE approach and represented all panel discussions. Over half (53%) of the total panel discussions concerned the use of research evidence. When evidence was considered sufficient and clear, the decision-making process proved rapid.The GRADE EtD framework provides structure to guidelines panel meetings, and ensures that the panelists consider all established formal GRADE criteria as they decide on the recommendation text, strength, and direction (for or against an intervention). This is the first study assessing the use of GRADE's EtD framework during real-time guidelines development using panel discussions. Given the widespread use of GRADE, this study provides important information for practice recommendations generated when guidelines panels explicitly follow, in a transparent and systematic manner, the structured GRADE EtD framework. By recognizing the extent to which panels discuss and consider GRADE and other (non-GRADE) criteria for producing guideline recommendations, we are one step closer to understanding the decision-making process in panels that use a structured framework such as the GRADE EtD framework.

P24 revisited: a landscape review of antigen detection for early HIV diagnosis.

: Despite major advances in HIV testing, early detection of infection at the point of care (PoC) remains a key challenge. Although rapid antibody PoC and laboratory-based nucleic acid amplification tests dominate the diagnostics market, the viral capsid protein p24 is recognized as an alternative early virological biomarker of infection. However, the detection of ultra-low levels of p24 at the PoC has proven challenging. Here we review the landscape of p24 diagnostics to identify knowledge gaps and barriers and help shape future research agendas. Five hundred and seventy-four research articles to May 2018 that propose or evaluate diagnostic assays for p24 were identified and reviewed. We give a brief history of diagnostic development, and the utility of p24 as a biomarker in different populations such as infants, the newly infected, those on preexposure prophylaxis and self-testers. We review the performance of commercial p24 assays and consider elements such as immune complex disruption, resource-poor settings, prevalence, and assay antibodies. Emerging and ultrasensitive assays are reviewed and show a number of promising approaches but further translation has been limited. We summarize studies on the health economic benefits of using antigen testing. Finally, we speculate on the future uses of high-performance p24 assays, particularly, if available in self-test format.

Diagnostic accuracy in field conditions of the sickle SCAN\xae rapid test for sickle cell disease among children and adults in two West African settings: the DREPATEST study

BackgroundSickle cell disease (SCD) accounts for 5% of mortality in African children aged < 5 years. Improving the care management and quality of life of patients with SCD requires a reliable diagnosis in resource-limited settings. We assessed the diagnostic accuracy of the rapid Sickle SCAN® point-of-care (POC) test for SCD used in field conditions in two West-African countries.MethodsWe conducted a case-control study in Bamako (Mali) and Lomé (Togo). Known cases of sickle cell disease (HbSS, HbSC), trait (HbAS), HbC heterozygotes (HbAC) and homozygous (HbCC), aged ≥6 months were compared to Controls (HbAA), recruited by convenience. All subjects received both an index rapid POC test and a gold standard (high-performance liquid chromatography in Bamako; capillary electrophoresis in Lomé). Personnel conducting tests were blinded from subjects’ SCD status. Sensitivity and specificity were calculated for each phenotype. Practicality was assessed by local healthcare professionals familiar with national diagnostic methods and their associated constraints.ResultsIn Togo, 209 Cases (45 HbAS, 39 HbAC, 41 HbSS, 44 HbSC and 40 HbCC phenotypes) were compared to 86 Controls (HbAA). 100% sensitivity and specificity were observed for AA Controls and HbCC cases. Estimated sensitivity was 97.7% [95% confidence interval: 88.0–99.9], 97.6% [87.1–99.9%], 95.6% [84.8–99.5%], and 94.9% [82.7–99.4], for HbSC, HbSS, HbAS, and HbAC, respectively. Specificity exceeded 99.2% for all phenotypes. Among 160 cases and 80 controls in Mali, rapid testing was 100% sensitive and specific. Rapid testing was well accepted by local healthcare professionals.ConclusionRapid POC testing is 100% accurate for homozygote healthy people and excellent (Togo) or perfect (Mali) for sickle cell trait and disease patients. In addition to its comparable diagnostic performance, this test is cheaper, easier to implement, and logistically more convenient than the current standard diagnostic methods in use. Its predictive value indicators and diagnostic accuracy in newborns should be further evaluated prior to implementation in large-scale screening programs in resource-limited settings where SCD is prevalent.

Clinical evaluation of rapid fluorescent diagnostic immunochromatographic test for influenza A virus (H1N1)

Rapid diagnostic tests (RDTs) have been developed to detect influenza A virus for the swift diagnosis and management of patients. However, despite the simplicity and convenience, the low sensitivity of RDTs remains a limitation for their use in point of care testing (POCT). In this study, we developed a rapid fluorescent immunochromatographic strip test (FICT) and the performance of FICT was confirmed by the real-time reverse transcription-polymerase chain reaction (rRT-PCR) of H1N1, compared with that of RDT. The limit of detection (LOD) of FICT was improved by 16-fold compared to RDT. FICT showed 85.29% sensitivity (29/34) (95% Confidence Interval [95% CI]: 68.94 to 95.05), 100% specificity (26/26) (95% CI: 86.78 to 100.00), and a strong correlation (kappa; 0. 92) compared with rRT-PCR (20 ≤ Ct ≤ 36). In contrast, RDT (Standard Diagnostics [SD] BIOLINE Influenza Ag A/ B/ A(H1N1) Pandemic) showed 55.88% sensitivity (19/34) (95% CI: 37.87 to 72.82), 100% specificity (26/26) (95% CI: 77.07 to 100), and had a fair correlation with rRT-PCR (kappa; 0. 75). FICT had better sensitivity than RDT (P < 0.01; McNemar’s test). Therefore, FICT has the potential to improve the quality of current rapid POCT for the diagnosis of influenza A/H1N1 infection.