scholarly journals Feasibility and Field Performance of a Simultaneous Syphilis and HIV Point-of-Care Test Based Screening Strategy in at Risk Populations in Edmonton, Canada

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Joshua Bergman ◽  
Jennifer Gratrix ◽  
Sabrina Plitt ◽  
Jayne Fenton ◽  
Chris Archibald ◽  
...  

Few studies have evaluated the feasibility of delivering syphilis point-of-care (POC) testing in outreach (nonclinical) settings in resource rich countries. The objectives of the study were to evaluate the feasibility and diagnostic performance of performing both HIV and syphilis POC testing in outreach settings and to document new cases identified in the study population. 1,265 outreach testing visits were offered syphilis and HIV POC testing and 81.5% (n=1,031) consented to testing. In our population, the SD Bioline 3.0 Syphilis Test had a sensitivity of 85.3% [CI (68.9–95.0)], specificity of 100.0% [CI (99.6–100.0)], positive predictive value (PPV) of 100.0% [CI (88.1–100.0)], and negative predictive value (NPV) of 99.5% [CI (98.9–99.8)]. Test characteristics for the INSTI HIV-1/HIV-2 Antibody Test had a 100.0% sensitivity [CI (39.8–100.00], 99.8 specificity [CI (99.3–100)], 66.7% PPV [CI (22.3–95.7)], and 100.0% NPV [CI (99.6–100.0)]. Four new cases of syphilis and four new HIV cases were diagnosed. In summary, at risk population seeking STI testing found POC tests to be acceptable, the POC tests performed well in outreach settings, and new cases of syphilis and HIV were identified and linked to treatment and care.

Author(s):  
Mehal Churiwal ◽  
Kelly D. Lin ◽  
Salman Khan ◽  
Srijana Chhetri ◽  
Meredith S. Muller ◽  
...  

Point-of-care (POC) tests to detect SARS-CoV-2 antibodies offer quick assessment of serostatus after natural infection or vaccination. We compared the field performance of the BioMedomics COVID-19 IgM/IgG Rapid Antibody Test against an ELISA in 303 participants enrolled in a SARS-CoV-2 household cohort study. The rapid antibody test was easily implemented with consistent interpretation across 14 users in a variety of field settings. Compared with ELISA, detection of seroconversion lagged by 5 to 10 days. However, it retained a sensitivity of 90% (160/177, 95% confidence interval [CI] 85–94%) and specificity of 100% (43/43, 95% CI 92–100%) for those tested 3 to 5 weeks after symptom onset. Sensitivity was diminished among those with asymptomatic infection (74% [14/19], 95% CI 49–91%) and early in infection (45% [29/64], 95% CI 33–58%). When used appropriately, rapid antibody tests offer a convenient way to detect symptomatic infections during convalescence.


2021 ◽  
Vol 7 (3) ◽  
pp. 233
Author(s):  
Philipp Foessleitner ◽  
Herbert Kiss ◽  
Julia Deinsberger ◽  
Julia Ott ◽  
Lorenz Zierhut ◽  
...  

Pregnant women have an increased risk of vulvovaginal candidosis. Recurrent candidosis is under debate as a contributor to preterm birth, and vertical transmission may cause diaper dermatitis and oral thrush in the newborn. Apart from cultural methods, the gold standard for diagnosing candidosis is Gram staining, which is time-consuming and requires laboratory facilities. The objective of this prospective study was to validate a point-of-care vaginal yeast detection assay (SavvyCheckÔ Vaginal Yeast Test) and to evaluate it in asymptomatic pregnant women. We enrolled 200 participants, 100 of whom had vulvovaginal candidosis according to Gram stain (study group) and 100 were healthy pregnant controls (control group). Of these, 22 participants (11%) had invalid test results. The point-of-care test of the remaining 85 and 93 study participants in the study and control groups, respectively, showed a sensitivity of 94.1%, specificity of 98.9%, positive predictive value of 90.3%, and negative predictive value of 99.4% when compared with Gram stain. In conclusion, we found a high correlation between the SavvyCheckÔ Vaginal Yeast Test and Gram-stained smears during pregnancy. This suggests a potential role of this point-of-care test as a screening tool for asymptomatic pregnant women in early gestation.


2020 ◽  
Author(s):  
Rama Vancheeswaran ◽  
Merlin L Willcox ◽  
Beth Stuart ◽  
Matthew Knight ◽  
Hala Kandil ◽  
...  

AbstractObjectivesTo assess the real-world diagnostic accuracy of the Livzon point-of-care rapid test for antibodies to SARS-COV-2DesignProspective cohort studySettingDistrict general hospital in EnglandParticipants173 Patients and 224 hospital staff with a history of COVID-19 symptoms, and who underwent PCR and/or reference antibody testing for COVID-19.InterventionsThe Livzon point-of-care (POC) lateral flow immunoassay rapid antibody test (IgM and IgG) was conducted at least 7 days after onset of symptoms and compared to the composite reference standard of PCR for SARS-COV-2 plus reference laboratory testing for antibodies to SARS-COV-2. The SARS-CoV-2 RT-PCR was tested using the available molecular technology during the study time (PHE laboratories, GeneXpert® system Xpert, Xpress SARS-CoV-2 and Source bioscience laboratory). All molecular platforms/assays were PHE/NHSE approved. The reference antibody test was the Elecsys Anti-SARS-CoV-2 assay (Roche diagnostics GmBH).Main outcome measuresSensitivity and specificity of the rapid antibody testResultsThe reference antibody test was positive in 190/268 (70.9%) of participants with a history of symptoms suggestive of COVID-19; in the majority (n=312) the POC test was taken 35 days or more after onset of symptoms. The POC antibody test had an overall sensitivity of 90.1% (292/328, 95% CI 86.3 – 93.1) and specificity of 100% (68/68, 95% CI 94.7 - 100) for confirming prior SARS-CoV-2 infection when compared to the composite reference standard. Sensitivity was 97.8% (89/92, 95% CI 92.3% to 99.7%) in participants who had been admitted to hospital and 84.4% (124/147, 95% CI 77.5% to 89.8%) in those with milder illness who had never been seen in hospital.ConclusionsThe Livzon point-of-care antibody test had comparable sensitivity and specificity to the reference laboratory antibody test, so could be used in clinical settings to support decision-making about patients presenting with more than 10 days of symptoms of COVID-19.What is already known on this topic-Presence of IgG and IgM antibodies to SARS-COV-2 indicates that the person was infected at least 7 days previously and is usually no longer infectious.-Rapid point-of-care tests for antibodies to SARS-COV-2 are widely available, cheap and easy to use-Preliminary evaluations suggested that rapid antibody tests may have insufficient accuracy to be useful for testing individual patients.What this study adds-The rapid point-of-care test for antibodies to SARS-COV-2 was 90.1% sensitive and 100% specific compared to reference standards for prior infection with COVID-19.-This is comparable to reference antibody tests-The point-of-care test evaluated in this study could be used to support clinical decision-making in real time, for patients presenting with symptoms of possible COVID-19 with at least 10 days of symptoms.


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.


2020 ◽  
pp. medethics-2020-107048
Author(s):  
Anneke M Lucassen ◽  
John Henry McDermott ◽  
William Newman

We thank Parker and Wright for engaging in this roundtable debate in such a spirited way. The ‘Pharmacogenetic [test] to Avoid Loss of Hearing’ (PALOH) Trial is the first time a genetic point of care test has been applied in the acute neonatal setting; therefore, it is not surprising that questions have been raised which require debate, discussion and clarification. Parker and Wright misattribute several assumptions to the roundtable authors, which we would like to clarify here. Since they raise wider questions about the PALOH trial itself, several of the roundtable discussants have made a joint response.


2019 ◽  
Vol 5 (1) ◽  
pp. e000605 ◽  
Author(s):  
Manon Breukers ◽  
Dorieke Haase ◽  
Stephan Konijnenberg ◽  
Tiburtius V S Klos ◽  
Geert-Jan Dinant ◽  
...  

ObjectivesDynamic ultrasound (US) imaging shows promising possibilities for accurate imaging in diagnosing anterior cruciate ligament (ACL) tears and can be used as a point-of-care test. The aim of this study is to determine the diagnostic accuracy of dynamic US imaging for detecting partial and complete ACL tears.Methods247 patients presenting with knee complaints, who underwent dynamic US imaging as well as arthroscopy for any intra-articular knee pathology, were retrospectively evaluated. We differentiated between partial and complete ACL tears.ResultsDynamic US imaging revealed 95 of 108 arthroscopically confirmed ACL tears (sensitivity 88%, specificity 82%, positive predictive value (PPV) 79%, negative predictive value (NPV) 90%, and diagnostic OR (DOR) of 33.3). Sensitivity of US in the detection of partial ACL tears was 52%, specificity 85%, PPV 52%, NPV 84% and DOR 5.8. Complete ACL tears were depicted with a sensitivity of 79%, specificity of 89%, PPV of 63%, NPV of 95% and DOR 29.8. Multivariate regression analysis adjusting for age (dichotomised per 5 years) and previous knee surgery showed similar DOR.ConclusionThe excellent NPV for complete ACL tears indicates that dynamic US imaging can be used as an initial imaging point-of-care test. However, the clinical presentation should be taken into account, especially in case of subtotal tears. Whereas it seems relatively easy to differentiate between (small) partial ACL tears, complete ACL tears and no tears, it seems to be difficult to differentiate subtotal tears from complete tears.


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.


Viruses ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 183
Author(s):  
Michèle Bergmann ◽  
Mike Holzheu ◽  
Yury Zablotski ◽  
Stephanie Speck ◽  
Uwe Truyen ◽  
...  

(1) Background: Antibody testing is commonly used to assess a dog’s immune status. For detection of antibodies against canine adenoviruses (CAVs), one point-of-care (POC) test is available. This study assessed the POC test´s performance. (2) Methods: Sera of 198 privately owned dogs and 40 specific pathogen-free (SPF) dogs were included. The reference standard for detection of anti-CAV antibodies was virus neutralization (VN) using CAV-1 and CAV-2 antigens. Specificity, sensitivity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy (OA) of the POC test were assessed. Specificity was considered most important. (3) Results: Prevalence of CAV-1 neutralizing antibodies (≥10) was 76% (182/238) in all dogs, 92% (182/198) in the subgroup of privately owned dogs, and 0% (0/40) in SPF dogs. Prevalence of CAV-2 neutralizing antibodies (≥10) was 76% (181/238) in all dogs, 91% (181/198) in privately owned dogs, and 0% (0/40) in SPF dogs. Specificity for detection of CAV-1 antibodies was lower (overall dogs, 88%; privately owned dogs, 56%; SPF dogs, 100%) compared with specificity for detection of CAV-2 antibodies (overall dogs, 90%; privately owned dogs, 65%; SPF dogs, 100%). (4) Conclusions: Since false positive results will lead to potentially unprotected dogs not being vaccinated, specificity should be improved to reliably detect anti-CAV antibodies that prevent infectious canine hepatitis in dogs.


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