scholarly journals Diagnostic accuracy of the Cepheid 3-gene host response fingerstick blood test in a prospective, multi-site study: interim results

Author(s):  
Jayne S Sutherland ◽  
Gian van der Spuy ◽  
Awa Gindeh ◽  
Nguyen Thuy Thuong ◽  
Ann Ritah Namuganga ◽  
...  

Abstract Background The development of a fast and accurate, non-sputum-based point-of-care triage test for tuberculosis (TB) would have a major impact on combating the TB burden worldwide. A new fingerstick blood test has been developed by Cepheid (the Xpert-MTB-Host Response (HR)-Prototype), which generates a ‘TB score’ based on mRNA expression of 3 genes. Here we describe the first prospective findings of the MTB-HR prototype. Methods Fingerstick blood from adults presenting with symptoms compatible with TB in South Africa, The Gambia, Uganda and Vietnam was analysed using the Cepheid GeneXpert MTB-HR prototype. Accuracy of the Xpert MTB-HR cartridge was determined in relation to GeneXpert Ultra results and a composite microbiological score (GeneXpert Ultra and liquid culture) with patients classified as having TB or other respiratory diseases (ORD). Results When data from all sites (n=75 TB, 120 ORD) were analysed, the TB score discriminated between TB and ORD with an AUC of 0·94 (CI, 0·91-0·97), sensitivity of 87% (CI, 77-93%) and specificity of 94% (88-97%). When sensitivity was set at 90% for a triage test, specificity was 86% (CI, 75-97%). These results were not influenced by HIV status or geographical location. When evaluated against a composite microbiological score (n=80 TB, 111 ORD), the TB score was able to discriminate between TB and ORD with an AUC of 0·88 (CI, 0·83-0·94), 80% sensitivity (CI, 76-85%) and 94% specificity (CI, 91-96%). Conclusions Our interim data indicate the Cepheid MTB-HR cartridge reaches the minimal target product profile for a point of care triage test for TB using fingerstick blood, regardless of geographic area or HIV infection status.

Author(s):  
Giuseppe Vetrugno ◽  
Daniele Ignazio La Milia ◽  
Floriana D’Ambrosio ◽  
Marcello Di Pumpo ◽  
Roberta Pastorino ◽  
...  

Healthcare workers are at the forefront against COVID-19, worldwide. Since Fondazione Policlinico Universitario A. Gemelli (FPG) IRCCS was enlisted as a COVID-19 hospital, the healthcare workers deployed to COVID-19 wards were separated from those with limited/no exposure, whereas the administrative staff were designated to work from home. Between 4 June and 3 July 2020, an investigation was conducted to evaluate the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin (IgG) antibodies among the employees of the FPG using point-of-care (POC) and venous blood tests. Sensitivity, specificity, and predictive values were determined with reverse-transcription polymerase chain reaction on nasal/oropharyngeal swabs as the diagnostic gold standard. The participants enrolled amounted to 4777. Seroprevalence was 3.66% using the POC test and 1.19% using the venous blood test, with a significant difference (p < 0.05). The POC test sensitivity and specificity were, respectively, 63.64% (95% confidence interval (CI): 62.20% to 65.04%) and 96.64% (95% CI: 96.05% to 97.13%), while those of the venous blood test were, respectively, 78.79% (95% CI: 77.58% to 79.94%) and 99.36% (95% CI: 99.07% to 99.55%). Among the low-risk populations, the POC test’s predictive values were 58.33% (positive) and 98.23% (negative), whereas those of the venous blood test were 92.86% (positive) and 98.53% (negative). According to our study, these serological tests cannot be a valid alternative to diagnose COVID-19 infection in progress.


2017 ◽  
Vol 94 (3) ◽  
pp. 194-199 ◽  
Author(s):  
James Blain Johnston ◽  
Joss N Reimer ◽  
John L Wylie ◽  
Jared Bullard

ObjectivesHIV point-of-care testing (POCT) has been available in Manitoba since 2008. This study evaluated the effectiveness of POCT at identifying individuals with previously unknown HIV status, its effects on clinical outcomes and the characteristics of the populations reached.MethodsA retrospective database review was conducted for individuals who received HIV POCT from 2011 to 2014. Time to linkage to care and viral load suppression were compared between individuals who tested positive for HIV using POCT and controls identified as positive through standard screening. Testing outcomes for labouring women with undocumented HIV status accessing POCT during labour were also assessed.Results3204 individuals received POCT (1055 females (32.9%) and 2149 males (67.1%)), being the first recorded HIV test for 2205 (68.8%). Males were more likely to be targeted with POCT as their first recorded HIV test (adjusted OR (AOR) 1.40). Between the two main test sites (Main Street Project (MSP) and Nine Circles Community Health Centre), MSP tested relatively fewer males (AOR 0.79) but a higher proportion of members of all age groups over 30 years old (AOR 1.83, 2.51 and 3.64 for age groups 30–39, 40–49 and >50, respectively). There was no difference in time to linkage to care (p=0.345) or viral load suppression (p=0.405) between the POCT and standard screening cohorts. Of 215 women presenting in labour with unknown HIV status, one was identified as HIV positive.ConclusionsPOCT in Manitoba has been successful at identifying individuals with previously unknown HIV-positive status. Demographic differences between the two main testing sites support that this intervention is reaching unique populations. Given that we observed no significant difference in time to clinical outcomes, it is reasonable to continue using POCT as a targeted intervention.MeSH termsHIV infection; rapid HIV testing; vertical infectious disease transmission; community outreach; service delivery; marginalised populations.


2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Carlo Cafiero ◽  
Marco Matarasso ◽  
Gaetano Marenzi ◽  
Vincenzo Iorio Siciliano ◽  
Loredana Bellia ◽  
...  

In the industrialized part of the world, an increasing number of people live the old age without too many restrictions due to illness or physiological impairment. This group is known asthe young elderly. On the contrary, a consistent part of seniors develops a greater number of medical conditions and become more and more dependent, these arethe old elderly. The first cause of tooth lost in industrialized word is periodontitis that generally strikes people older than 40 years and determines serious detriment of the stomatognatic organ. Smoking and stress are risk factors for periodontitis that are common and shared between young, adult, and older age. Diabetes mellitus, obesity, and osteoporosis are very frequent pathological situations in older age. They have been identified as cofactors in the progression of periodontitis. Many dental associations recognize the importance of continued research on oral fluids diagnostics and welcome the development of rapid point-of-care tests providing accurate measurements of clinically validated biomarkers. At present, well-studied molecules associated with host response factors and with derived tissue destruction mediators have been proposed as diagnostic biomarkers for periodontitis detected in the oral fluids.


BJPsych Open ◽  
2020 ◽  
Vol 6 (6) ◽  
Author(s):  
Joseph Butler ◽  
Simone de Cassan ◽  
Margaret Glogowska ◽  
Thomas R. Fanshawe ◽  
Phil Turner ◽  
...  

Background Physical health outcomes in severe mental illness are worse than in the general population. Routine physical health check completion in this group is poor. Aims To quantitatively and qualitatively evaluate the impact of point of care (POC) blood testing on physical health check completion in community mental health services. Method In a prospective cohort design, we equipped an early intervention service (EIS) and a community mental health team (CMHT) with a POC blood testing device for 6 months. We compared rates of blood test and full physical health check completion in the intervention teams with a matched EIS and CMHT, historically and during the intervention. We explored attitudes to POC testing using thematic analysis of semi-structured interviews with patients and clinicians. Results Although the CMHT scarcely used the POC device and saw no change in outcomes, direct comparison of testing rates in the intervention period showed increased physical health check completion in the EIS with the device (rate ratio RR = 5.18; 95% CI 2.54–12.44; P < 0.001) compared with usual care. The rate was consistent with the EIS's increasing rate of testing over time (RR = 0.45; 95% 0.09–2.08; P = 0.32). Similar trends were seen in blood test completion. POC testing was acceptable to patients but clinicians reported usability, provision and impact on the therapeutic relationship as barriers to uptake. Conclusions POC testing was beneficial and acceptable to patients and may increase physical health check uptake. Further research, accounting for clinician barriers, is needed to evaluate its clinical and cost-effectiveness.


2020 ◽  
Vol 29 (11) ◽  
pp. 649-657
Author(s):  
Leon Jonker ◽  
Danielle Smith ◽  
Emma Mark ◽  
Jose Schutter ◽  
Sarah Thornthwaite ◽  
...  

Objective: To appraise the performance of a new point-of-care wound infection detection kit in diabetic foot ulcers (DFUs), using clinician opinion as the primary comparator. The proprietary swab-based chromatic Glycologic (Glycologic Ltd., UK) detection kit used in this study is designed to detect host response to pathogenic levels of bacteria in wounds. Method: In high-risk podiatry clinics, patients with DFUs were recruited and infection detection kit test results compared with initial clinician opinion. Chi-squared tests, principal component analysis (PCA) and multiple regression analysis were performed to determine which variables were possibly associated with infection. The variables considered were patients' wound parameters, wider vascular comorbidity and demographics. Results: A total of 136 patients, providing 383 wound swabs, were included in the study. Total agreement in terms of DFU wound assessment for infection—between podiatrists' clinical opinion and Glycologic kit test result—was observed in 79% of cases (301/383). For 56 of the 349 negative infection detection kit test results (16%), podiatrists identified a ‘possible’ or ‘definite’ infection. Conversely, in 14 of the 307 cases (4.6%) where podiatrists deemed the wound ‘not infected’, the infection detection kit test showed a colour change. Regression analysis and PCA showed that clinical signs of wound infection, namely erythema, purulence and odour, were all significantly associated with both a positive clinical opinion and infection detection kit test result. However, in the case of the infection detection kit, a patient's number of lesions and vascular comorbidities were also significantly correlated with a positive test result. Conclusion: A host response to critical pathological levels of bioburden in a wound—as detected with the infection detection kit—may partly be determined by an individual patient's (vascular) health and therefore be person-specific. Further research is indicated to determine the relationship between an infection detection kit test result and the microbiological status of the wound.


2019 ◽  
Vol 11 (515) ◽  
pp. eaaw8287 ◽  
Author(s):  
Rushdy Ahmad ◽  
Liangxia Xie ◽  
Margaret Pyle ◽  
Marta F. Suarez ◽  
Tobias Broger ◽  
...  

Improved tuberculosis (TB) prevention and control depend critically on the development of a simple, readily accessible rapid triage test to stratify TB risk. We hypothesized that a blood protein-based host response signature for active TB (ATB) could distinguish it from other TB-like disease (OTD) in adult patients with persistent cough, thereby providing a foundation for a point-of-care (POC) triage test for ATB. Three adult cohorts consisting of ATB suspects were recruited. A bead-based immunoassay and machine learning algorithms identified a panel of four host blood proteins, interleukin-6 (IL-6), IL-8, IL-18, and vascular endothelial growth factor (VEGF), that distinguished ATB from OTD. An ultrasensitive POC-amenable single-molecule array (Simoa) panel was configured, and the ATB diagnostic algorithm underwent blind validation in an independent, multinational cohort in which ATB was distinguished from OTD with receiver operator characteristic–area under the curve (ROC-AUC) of 0.80 [95% confidence interval (CI), 0.75 to 0.85], 80% sensitivity (95% CI, 73 to 85%), and 65% specificity (95% CI, 57 to 71%). When host antibodies against TB antigen Ag85B were added to the panel, performance improved to 86% sensitivity and 69% specificity. A blood-based host response panel consisting of four proteins and antibodies to one TB antigen can help to differentiate ATB from other causes of persistent cough in patients with and without HIV infection from Africa, Asia, and South America. Performance characteristics approach World Health Organization (WHO) target product profile accuracy requirements and may provide the foundation for an urgently needed blood-based POC TB triage test.


2011 ◽  
Vol 23 (6) ◽  
pp. 1109-1113 ◽  
Author(s):  
Amrita Banerjee ◽  
Shauna L. Blois ◽  
R. Darren Wood

Thromboelastography (TEG) is a point-of-care whole blood test of hemostasis. While TEG is becoming more widely used in veterinary medicine, few studies describe the use of TEG in cats. The objectives of the current study were to: 1) document the range of TEG variables produced in healthy cats using 3 sample types (citrated native, kaolin-activated, and tissue factor–activated), and 2) determine if there was a significant difference between 2 separate samples obtained from individual healthy cats on the same day. Jugular venipuncture was performed in 20 cats, and citrated blood collected for TEG. TEG analysis was performed on citrated native, kaolin-activated, and tissue factor–activated blood for each sample. Two hours later, the procedure was repeated from the opposite jugular vein, yielding a total of 120 analyses. Reaction time ( R), alpha angle (α), kappa value (κ), and maximum amplitude (MA) were recorded from each tracing. No significant differences were found between TEG tracings from the first and second venipuncture samples. Significant differences were found between sample types for R, α, κ, and MA. Means for citrated native/kaolin-activated/tissue factor–activated methods were R = 4.1/3.7/0.6 min; κ = 2.5/1.8/2.2 min; α = 59.9/65.1/70.4 degrees; MA = 47.4/49.9/44.7 mm. A limitation of this study was the small number of cats used. Thromboelastography analysis may be a suitable method of evaluating hemostasis in cats.


2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Linda Petrone ◽  
Angela Cannas ◽  
Francesco Aloi ◽  
Martin Nsubuga ◽  
Joseph Sserumkuma ◽  
...  

Objectives. Interferon-γinducible protein 10 (IP-10), either in blood or in urine, has been proposed as a tuberculosis (TB) biomarker for adults. This study aims to evaluate the potential of IP-10 diagnostics in children from Uganda, a high TB-endemic country.Methods. IP-10 was measured in the blood and urine concomitantly taken from children who were prospectively enrolled with suspected active TB, with or without HIV infection. Clinical/microbiological parameters and commercially available TB-immune assays (tuberculin skin test (TST) and QuantiFERON TB-Gold In-Tube (QFT-IT)) were concomitantly evaluated.Results. One hundred twenty-eight children were prospectively enrolled. The analysis was performed on 111 children: 80 (72%) of them were HIV-uninfected and 31 (27.9%) were HIV-infected. Thirty-three healthy adult donors (HAD) were included as controls. The data showed that IP-10 is detectable in the urine and blood of children with active TB, independent of HIV status and age. However, although IP-10 levels were higher in active TB children compared to HAD, the accuracy of identifying “active TB” was low and similar to the TST and QFT-IT.Conclusion. IP-10 levels are higher in children with respiratory illness compared to controls, independent of “TB status” suggesting that the evaluation of this parameter can be used as an inflammatory marker more than a TB test.


2002 ◽  
Vol 5 (1) ◽  
pp. 29-35 ◽  
Author(s):  
Roberto Colom ◽  
Luis F. García ◽  
Manuel Juan-Espinosa ◽  
Francisco J. Abad

There is an increasing number of studies claiming that the sex differences in general intelligence are “real.” The empirical evidence is based on the summation of the standardized sex differences in several cognitive batteries. However, the scientific construct of general ability rests on the correlations among test scores, rather than on their summation. The latter (ability in general) is an arbitrary variable, not a scientific construct. General ability is not a function of any particular cognitive test, but a source of variance evidenced by the correlation between several diverse tests, each of which reflects general ability (g) to some extent, but also group factors and test specificity. Because there are important educational, economic, and social consequences of a group difference in general ability, it is especially germane to evaluate the possibility of an average sex difference in its proxy measures, such as IQ. The Spanish standardization of the WAIS-III is analyzed in the present study. The sample was made up of 703 females and 666 males, aged 15-94, drawn as a representative sample of the population in terms of educational level and geographical location. Although a male advantage of 3.6 IQ points is observed, the difference is in “ability in general,” not in “general ability” (g). Given that the main ingredient of the strong association between IQ and a broad range of social correlates is g, and given that there is no sex difference in g, then the average IQ sex-difference favoring males must be attributed to specific group factors and test specificity.


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