scholarly journals Point-of-care tests for sexually transmissible infections: what do ‘end users' want?

Sexual Health ◽  
2013 ◽  
Vol 10 (6) ◽  
pp. 541 ◽  
Author(s):  
Anne M. Rompalo ◽  
Yu-Hsiang Hsieh ◽  
Terry Hogan ◽  
Mathilda Barnes ◽  
Mary Jett-Goheen ◽  
...  

Background Clinicians and developers identify sensitivity as an important quality in a point-of-care test (POCT) for sexually transmissible infections (STIs). Little information exists regarding what patients want for STI POCTs. Methods: A qualitative study, encompassing five focus groups among attendees of STI and adolescent health centres in Baltimore, Maryland, and Cincinnati, Ohio, were conducted between March 2008 and April 2009. Discussion topics included advantages and disadvantages of having a POCT, perceived barriers to using POCTs in the clinic setting and at home, priorities for the development of new POCTs for STIs, and envisioned characteristics of an ideal POCT. All discussions were recorded and transcribed. A qualitative content analysis was performed to examine frequencies or patterns of recurring codes, which were regrouped and indexed to identify salient themes. Results: Patients attending STI and adolescent outpatient clinics are in favour of diagnostic tests that are rapid, easy to read and simple to use. Home testing options for POCTs were acceptable and provided better confidentiality, privacy and convenience, but clinic-based POCTs were also acceptable because they offer definitive results and ensure immediate treatment. Barriers to home POCTs centred on cost and the ability to read and perform the test correctly at home. Opinions did not differ by patient ethnicity, except that Hispanic participants questioned the reliability of home test results, wanted high sensitivity and desired bilingual instructions. Conclusions: Patients attending STI and adolescent medical centres are in favour of STI POCTs if they are affordable, rapid, easy to read and simple to use.

Author(s):  
Tobias Broger ◽  
Bianca Sossen ◽  
Elloise du Toit ◽  
Andrew D. Kerkhoff ◽  
Charlotte Schutz ◽  
...  

2019 ◽  
Vol 26 (11) ◽  
pp. 1946-1959 ◽  
Author(s):  
Le Minh Tu Phan ◽  
Lemma Teshome Tufa ◽  
Hwa-Jung Kim ◽  
Jaebeom Lee ◽  
Tae Jung Park

Background:Tuberculosis (TB), one of the leading causes of death worldwide, is difficult to diagnose based only on signs and symptoms. Methods for TB detection are continuously being researched to design novel effective clinical tools for the diagnosis of TB.Objective:This article reviews the methods to diagnose TB at the latent and active stages and to recognize prospective TB diagnostic methods based on nanomaterials.Methods:The current methods for TB diagnosis were reviewed by evaluating their advantages and disadvantages. Furthermore, the trends in TB detection using nanomaterials were discussed regarding their performance capacity for clinical diagnostic applications.Results:Current methods such as microscopy, culture, and tuberculin skin test are still being employed to diagnose TB, however, a highly sensitive point of care tool without false results is still needed. The utilization of nanomaterials to detect the specific TB biomarkers with high sensitivity and specificity can provide a possible strategy to rapidly diagnose TB. Although it is challenging for nanodiagnostic platforms to be assessed in clinical trials, active TB diagnosis using nanomaterials is highly expected to achieve clinical significance for regular application. In addition, aspects and future directions in developing the high-efficiency tools to diagnose active TB using advanced nanomaterials are expounded.Conclusion:This review suggests that nanomaterials have high potential as rapid, costeffective tools to enhance the diagnostic sensitivity and specificity for the accurate diagnosis, treatment, and prevention of TB. Hence, portable nanobiosensors can be alternative effective tests to be exploited globally after clinical trial execution.


Author(s):  
Paul C. Adamson ◽  
Jeffrey D. Klausner

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.


2016 ◽  
Vol 28 (7) ◽  
pp. 702-707 ◽  
Author(s):  
Stephen C Davies ◽  
Andrew Koh ◽  
Heather E Lindsay ◽  
Richard B Fulton ◽  
Suran L Fernando

An inner Sydney sexual health service introduced the option to gay and bisexual men of receiving a negative HIV result by SMS to mobile phone one business day after venipuncture (rapid SMS). Men could also choose one of the other options: a point-of-care-test (POCT), by phone, or in-person (clinicians could also require in-person). We followed-up patients choosing the rapid SMS method to ascertain their satisfaction. During 12 months, 473 men had 591 HIV tests. Of these tests, 5.4% were POCTs, 9.1% were in-person, 24% were by phone, and 62% were rapid SMS. HIV POCTs declined from being 22% of result methods in the pre-study period to 5.4% during the rapid SMS intervention period (odds ratio 0.20, 95% CI 0.13–0.32, P < 0.0001). Phone/in-person results declined from 78% to 33% (odds ratio 0.14, 95% CI 0.10–0.20, P < 0.0001). SMS was sent by the next business day in 95% of cases; 96% of men were satisfied; and 95% would choose this method for their next test. Of 77 men who previously had an HIV POCT, 56 (73%) elected a rapid SMS result rather than having another POCT. The higher accuracy of conventional serology was commonly expressed as the reason for choosing rapid SMS for results.


Sexual Health ◽  
2013 ◽  
Vol 10 (4) ◽  
pp. 348 ◽  
Author(s):  
Ben B. Hui ◽  
David P. Wilson ◽  
James S. Ward ◽  
Rebecca J. Guy ◽  
John M. Kaldor ◽  
...  

Background Despite the availability of testing and treatment, bacterial sexually transmissible infections (STIs) continue to occur at endemic levels in many remote Indigenous communities in Australia. New generation molecular point-of-care (POC) tests have high sensitivity, comparable with conventional diagnostic tests, and have the potential to increase the impact of STI screening. Methods: We developed mathematical models of gonorrhoea (Neisseria gonorrhoeae) and chlamydia (Chlamydia trachomatis) transmission in remote Indigenous communities in Australia to evaluate screening and treatment strategies that utilise POC tests. Results: The introduction of POC testing with 95% sensitivity could reduce the prevalence of gonorrhoea and chlamydia from 7.1% and 11.9% to 5.7% and 8.9%, respectively, under baseline screening coverage of 44% per year. If screening coverage is increased to 60% per year, prevalence is predicted to be reduced to 3.6% and 6.7%, respectively, under conventional testing, and further reduced to 1.8% and 3.1% with the introduction of POC testing. Increasing screening coverage to 80% per year will result in a reduction in the prevalence of gonorrhoea and chlamydia to 0.6% and 1.5%, respectively, and the virtual elimination of both STIs if POC testing is introduced. Conclusions: Modelling suggests that molecular POC tests of high sensitivity have great promise as a public health strategy for controlling chlamydia and gonorrhoea. However, evaluation of the cost-effectiveness of POC testing needs to be made before widespread implementation of this technology can be considered.


2020 ◽  
Author(s):  
Tristan W Clark ◽  
Nathan J Brendish ◽  
Stephen Poole ◽  
Vasanth V Naidu ◽  
Christopher Mansbridge ◽  
...  

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


2017 ◽  
Vol 24 (05) ◽  
pp. 656-664
Author(s):  
Hamid Mahmood ◽  
Talmeez Zaib ◽  
Zafar Hayat Maken ◽  
Ammara Waqar ◽  
Yasir Hassan ◽  
...  

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.


2016 ◽  
Vol 83 (4) ◽  
pp. 447-452
Author(s):  
Julia Ruoff ◽  
Sandra Bertulat ◽  
Onno Burfeind ◽  
Wolfgang Heuwieser

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.


2014 ◽  
Vol 25 (13) ◽  
pp. 956-959 ◽  
Author(s):  
L Rathunde ◽  
GMB Kussen ◽  
MP Beltrame ◽  
LM Dalla Costa ◽  
SM Raboni

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.


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