Novel High Sensitivity Tuberculosis Point-of-Care Test for People Living with HIV

2018 ◽  
Author(s):  
Tobias Broger ◽  
Bianca Sossen ◽  
Elloise du Toit ◽  
Andrew D. Kerkhoff ◽  
Charlotte Schutz ◽  
...  
Keyword(s):  
Point Of Care ◽  
High Sensitivity ◽  
People Living With Hiv ◽  
Point Of Care Test ◽  
Living With Hiv

Diagnostic tests for detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and pharyngeal specimens

2021 ◽  
Author(s):  
Paul C. Adamson ◽  
Jeffrey D. Klausner
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Bacterial Infections ◽  
Point Of Care ◽  
High Sensitivity ◽  
Population Level ◽  
The United States ◽  
Nucleic Acid Amplification ◽  
Point Of Care Test ◽  
Control And Prevention

Chlamydia trachomatis and Neisseria gonorrhoeae are two of the most often reported bacterial infections in the United States. The rectum and oropharynx are important anatomic sites of infection and can contribute to ongoing transmission. Nucleic acid amplification tests (NAATs) are the mainstays for the detection of C. trachomatis and N. gonorrhoeae infections owing to their high sensitivity and specificity. Several NAATs have been evaluated for testing in rectal and pharyngeal infections. A few assays recently received clearance by the Food and Drug Administration, including one point-of-care test. Those assays can be used for testing in symptomatic individuals, as well as for asymptomatic screening in certain patient populations. Routine screening for C. trachomatis in pharyngeal specimens is not recommended by the Centers for Disease Control and Prevention, though is often performed due to the use of multiplex assays. While expanding the types of settings for screening and using self-collected rectal and pharyngeal specimens can help to increase access and uptake of testing, additional research is needed to determine the potential benefits and costs associated with increased screening for rectal and pharyngeal C. trachomatis and N. gonorrhoeae infections on a population level.

Distinct Lipidomic Signatures in People Living With HIV: Combined Analysis of ACTG 5260s and MACS/WIHS

2021 ◽  
Author(s):  
Jennifer Jao ◽  
Lauren C Balmert ◽  
Shan Sun ◽  
Grace A McComsey ◽  
Todd T Brown ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
High Sensitivity ◽  
People Living With Hiv ◽  
Model Assessment ◽  
Metabolic Complications ◽  
Persons Living With Hiv ◽  
Before And After ◽  
Homeostatic Model Assessment ◽  
Positive Correlations ◽  
Living With Hiv

Abstract Context Disentangling contributions of HIV from antiretroviral therapy (ART) and understanding the effects of different ART on metabolic complications in persons living with HIV (PLHIV) has been challenging. Objective We assessed the effect of untreated HIV infection as well as different antiretroviral therapy (ART) on the metabolome/lipidome. Methods Widely targeted plasma metabolomic and lipidomic profiling was performed on HIV-seronegative individuals and people living with HIV (PLHIV) before and after initiating ART (tenofovir/emtricitabine plus atazanavir/ritonavir [ATV/r] or darunavir/ritonavir [DRV/r] or raltegravir [RAL]). Orthogonal partial least squares discriminant analysis was used to assess metabolites/lipid subspecies that discriminated between groups. Graphical lasso estimated group-specific metabolite/lipid subspecies networks associated with the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Correlations between inflammatory markers and metabolites/lipid subspecies were visualized using heat maps. Results Of 435 participants, 218 were PLHIV. Compared to HIV-seronegative individuals, ART-naive PLHIV exhibited higher levels of saturated triacylglycerols/triglycerides (TAGs) and 3-hydroxy-kynurenine, lower levels of unsaturated TAGs and N-acetyl-tryptophan, and a sparser and less heterogeneous network of metabolites/lipid subspecies associated with HOMA-IR. PLHIV on RAL vs ATV/r or DRV/r had lower saturated and unsaturated TAGs. Positive correlations were found between medium-long chain acylcarnitines (C14-C6 ACs), palmitate, and HOMA-IR for RAL but not ATV/r or DRV/r. Stronger correlations were seen for TAGs with interleukin 6 and high-sensitivity C-reactive protein after RAL vs ATV/r or DRV/r initiation; these correlations were absent in ART-naive PLHIV. Conclusion Alterations in the metabolome/lipidome suggest increased lipogenesis for ART-naive PLHIV vs HIV-seronegative individuals, increased TAG turnover for RAL vs ATV/r or DRV/r, and increased inflammation associated with this altered metabolome/lipidome after initiating ART. Future studies are needed to understand cardiometabolic consequences of lipogenesis and inflammation in PLHIV.

scholarly journals Diagnostic accuracy of a host response point-of-care test in patients with suspected COVID-19

2020 ◽  
Author(s):  
Tristan W Clark ◽  
Nathan J Brendish ◽  
Stephen Poole ◽  
Vasanth V Naidu ◽  
Christopher Mansbridge ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Host Response ◽  
Clinical Symptoms ◽  
Point Of Care ◽  
Patient Flow ◽  
High Sensitivity ◽  
Likelihood Ratios ◽  
Duration Of Symptoms ◽  
Point Of Care Test ◽  
Hospitalised Patients

AbstractRationaleManagement of the COVID-19 pandemic is hampered by long delays associated with centralised laboratory PCR testing. In hospitals this leads to poor patient flow and nosocomial transmission and rapid, accurate diagnostic tests are urgently required. The FebriDx is a point-of-care test that detects an antiviral host response protein in finger prick blood within 10 minutes, but its accuracy for the detection of COVID-19 is unknown.ObjectivesTo evaluate the diagnostic accuracy of FebriDx in hospitalised patients during the first wave of the pandemicMethodsMeasures of diagnostic accuracy were calculated based on FebriDx results compared to the reference standard of PCR, and stratified by duration of symptoms. A multivariable predictive model was developed and underwent internal validation.ResultsFebriDx was performed on 251 patients and gave a valid result in 248. 118 of 248 (48%) were PCR positive for COVID-19. Sensitivity of FebriDx for the identification of COVID-19 was 93% (110/118; 95% CI 87 to 97%) and specificity was 86% (112/130; 95%CI 79 to 92%). Positive and negative likelihood ratios were 6.73 (95%CI 4.37 to 10.37) and 0.08 (95%CI 0.04 to 0.15) respectively. In the multivariate model diagnosis of COVID-19 was not significantly influenced by clinical symptoms and signs, and FebriDx accuracy was not improved by restricting testing to those with duration of symptoms of less than seven days.ConclusionsDuring the first wave of the pandemic, FebriDx had high sensitivity for the identification of COVID-19 in hospitalised adults and could be deployed as a front door triage tool.Trial registrationISRCTN14966673

scholarly journals TUBERCULOUS PERICARDITIS AND PLEURITIS;

2017 ◽  
Vol 24 (05) ◽  
pp. 656-664
Author(s):  
Hamid Mahmood ◽  
Talmeez Zaib ◽  
Zafar Hayat Maken ◽  
Ammara Waqar ◽  
Yasir Hassan ◽  
...  
Keyword(s):  
Negative Predictive Value ◽  
Predictive Value ◽  
Point Of Care ◽  
High Sensitivity ◽  
Smear Microscopy ◽  
Diagnostic Validity ◽  
Standard Material ◽  
Point Of Care Test ◽  
Resource Limited ◽  
Attractive Point

Background: Diagnosis of Tubercles Pericarditis and Pleuritis remains thegreatest challenge for clinicians. WHO has recommended GeneXpert MTB/RIF assay as ascreening test for substitution of conventional methods for the initial diagnosis and prognosisof the extra pulmonary and pulmonary tuberculosis in developing countries. Objectives: Tofind out the diagnostic validity of GeneXpert assay for detection of Myco-bacterium tuberculosisin the pericardial and pleural effusions samples, keeping MTB culture as “Gold Standard”.Material and Methods: Total number of 286 samples of effusions (pericardial 128, pleural 158)were received, and processed for Zn smear microscopy, LJ culture, GeneXpert MTB/RIF assayaccording standard protocols. Efficacy for the detection of MTB was evaluated comparatively.Results: Out of 286effusions samples AFB was detected by Zn smear in 11 (3.8%) samples whileGeneXpert detected MTB in 43 (15.0%) and LJ culture 51 (17.8%). Zn smear showed sensitivity18.2%, specificity, 98.1%, Positive predictive value 81.8%, Negative predictive value 85.4 %, incomparison GeneXpert showed high sensitivity 84.3%, specificity 100%, with Positive predictivevalue 100%, and Negative predictive value 96.7%. Conclusion: GeneXpert assay is innovativetool in resource limited settings for prompt detection of MTB along with drug résistance. It isdefinitely an attractive point of care test, with High sensitivity and specificity along with turnouttime of two hours which facilitates timely diagnoses and appropriate management of tuberclePleuritis and Pericarditis.

Associations of β-hydroxybutyrate, cholesterol, triglycerides and high-density lipoproteins to non-esterified fatty acids pre- and postpartum

2016 ◽  
Vol 83 (4) ◽  
pp. 447-452
Author(s):  
Julia Ruoff ◽  
Sandra Bertulat ◽  
Onno Burfeind ◽  
Wolfgang Heuwieser
Keyword(s):  
Lipid Metabolism ◽  
Point Of Care ◽  
Characteristic Curve ◽  
High Sensitivity ◽  
Receiver Operator Characteristic Curve ◽  
Human Medicine ◽  
High Density ◽  
High Density Lipoproteins ◽  
Nefa Concentration ◽  
Point Of Care Test

While laboratory tests for measuring the concentration of NEFA in serum are well established, a point of care test to determine NEFA on farm is not available. Several hand-held measuring devices, however, have been validated for measuring β-hydroxybutyrate (BHBA) in cattle or cholesterol, triglycerides (TAG), and high-density lipoproteins (HDL) in human medicine, respectively. The objective of this study was to evaluate the association between NEFA and different parameters related to lipid metabolism. Specifically, we set out to determine if it is feasible to predict the concentration of NEFA by means of surrogate measures. The concentration of BHBA was determined by a hand-held device evaluated for use in cows, whereas the concentrations of the other parameters were determined by laboratory analysis because hand-held devices for cholesterol, TAG and HDL are only evaluated for human medicine so far. A total of 254 cows were included in the trial. One blood sample was taken from each cow between d 10 and d 1 prepartum. Second and third samples were collected on d 2 and d 10 postpartum, respectively. The coefficients of correlation between parameters were calculated and a receiver-operator characteristic curve analysis has been used. The prediction of NEFA concentrations using only one of the parameters was insufficient. However, a NEFA concentration ≥0·5 mEq/l could be predicted with a high sensitivity (i.e. Se = 0·88) and specificity (i.e. Sp = 0·93) from d 3 to d 1 prepartum and a NEFA concentration ≥0·7 mEq/l could be reliably predicted on d 2 postpartum (i.e. AUC = 0·89, Se = 0·89, Sp = 0·76) when using a combination of BHBA, cholesterol and TAG as surrogates. Overall, our results suggest that a combination of different parameters of lipid metabolism could be used as surrogates for NEFA.

Evaluation of the Alere Pima™ for CD4+ T lymphocytes counts in HIV-positive outpatients in Southern Brazil

2014 ◽  
Vol 25 (13) ◽  
pp. 956-959 ◽  
Author(s):  
L Rathunde ◽  
GMB Kussen ◽  
MP Beltrame ◽  
LM Dalla Costa ◽  
SM Raboni
Keyword(s):  
Flow Cytometry ◽  
T Lymphocytes ◽  
T Lymphocyte ◽  
Predictive Value ◽  
Opportunistic Infections ◽  
Point Of Care ◽  
High Sensitivity ◽  
Hiv Positive ◽  
Point Of Care Test ◽  
Patients At Risk

CD4 + lymphocyte counts are routinely ordered during the early phases of antiretroviral therapy and for prophylaxis of opportunistic infections in HIV-positive patients. Flow cytometry is the standard methodology for CD4 counts in Brazilian reference laboratories. However, these laboratories are located in large cities, frequently distant from patients, thus limiting patient access and delaying results. We compared a point-of-care test with flow cytometry determination of CD4+ T lymphocyte counts in HIV patients. We analysed 107 consecutive samples by both methods. Overall, the point-of-care test performed well, with excellent agreement between it and the standard method. Test results were concordant for patients with CD4+ T lymphocyte values above and below 200 cells/mm 3. The performance characteristics obtained were sensitivity 94% (95% CI 89.5–98.5%), specificity 93% (95% CI 88.2–97.8%), positive predictive value 86% (95% CI 79.4–92.6%), and negative predictive value 97% (95% CI 94–100%). The high sensitivity and specificity of the point-of-care test methodology suggest its utility as an alternative method for rapid measurement of CD4+ T lymphocytes in patients with limited access to reference laboratories, enabling prompt therapeutic intervention for patients at risk of progression to AIDS.

scholarly journals Costs of Point-of-Care Viral Load Testing for Adults and Children Living with HIV in Kenya

Diagnostics ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. 140
Author(s):  
Michelle Ann Bulterys ◽  
Patrick Oyaro ◽  
Evelyn Brown ◽  
Nashon Yongo ◽  
Enericah Karauki ◽  
...  
Keyword(s):  
Viral Load ◽  
Laboratory Testing ◽  
Point Of Care ◽  
Treatment Monitoring ◽  
Hiv Care ◽  
People Living With Hiv ◽  
Capital Costs ◽  
Adults And Children ◽  
Living With Hiv ◽  
Equipment Costs

Background: The number of people living with HIV (PLHIV) in need of treatment monitoring in low-and-middle-income countries is rapidly expanding, straining existing laboratory capacity. Point-of-care viral load (POC VL) testing can alleviate the burden on centralized laboratories and enable faster delivery of results, improving clinical outcomes. However, implementation costs are uncertain and will depend on clinic testing volume. We sought to estimate the costs of decentralized POC VL testing compared to centralized laboratory testing for adults and children receiving HIV care in Kenya. Methods: We conducted microcosting to estimate the per-patient costs of POC VL testing compared to known costs of centralized laboratory testing. We completed time-and-motion observations and stakeholder interviews to assess personnel structures, staff time, equipment costs, and laboratory processes associated with POC VL administration. Capital costs were estimated using a 5 year lifespan and a 3% annual discount rate. Results: We estimated that POC VL testing cost USD $24.25 per test, assuming a clinic is conducting 100 VL tests per month. Test cartridge and laboratory equipment costs accounted for most of the cost (62% and 28%, respectively). Costs varied by number of VL tests conducted at the clinic, ranging from $54.93 to $18.12 per test assuming 20 to 500 VL tests per month, respectively. A VL test processed at a centralized laboratory was estimated to cost USD $25.65. Conclusion: POC VL testing for HIV treatment monitoring can be feasibly implemented in clinics within Kenya and costs declined with higher testing volumes. Our cost estimates are useful to policymakers in planning resource allocation and can inform cost-effectiveness analyses evaluating POC VL testing.

scholarly journals Multiplexed, quantitative serological profiling of COVID-19 from blood by a point-of-care test

2021 ◽  
Vol 7 (26) ◽  
pp. eabg4901
Author(s):  
Jacob T. Heggestad ◽  
David S. Kinnamon ◽  
Lyra B. Olson ◽  
Jason Liu ◽  
Garrett Kelly ◽  
...  
Keyword(s):  
Prognostic Biomarker ◽  
Point Of Care ◽  
High Sensitivity ◽  
Interferon Γ ◽  
Live Virus ◽  
Point Of Care Test ◽  
Highly Sensitive ◽  
Good Concordance ◽  
Longitudinal Sampling ◽  
User Intervention

Highly sensitive, specific, and point-of-care (POC) serological assays are an essential tool to manage coronavirus disease 2019 (COVID-19). Here, we report on a microfluidic POC test that can profile the antibody response against multiple severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigens—spike S1 (S1), nucleocapsid (N), and the receptor binding domain (RBD)—simultaneously from 60 μl of blood, plasma, or serum. We assessed the levels of antibodies in plasma samples from 31 individuals (with longitudinal sampling) with severe COVID-19, 41 healthy individuals, and 18 individuals with seasonal coronavirus infections. This POC assay achieved high sensitivity and specificity, tracked seroconversion, and showed good concordance with a live virus microneutralization assay. We can also detect a prognostic biomarker of severity, IP-10 (interferon-γ–induced protein 10), on the same chip. Because our test requires minimal user intervention and is read by a handheld detector, it can be globally deployed to combat COVID-19.

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