scholarly journals Evaluation of a Point-of-Care Test for Pre-Vaccination Testing to Detect Antibodies against Canine Adenoviruses in Dogs

Viruses ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 183
Author(s):  
Michèle Bergmann ◽  
Mike Holzheu ◽  
Yury Zablotski ◽  
Stephanie Speck ◽  
Uwe Truyen ◽  
...  
Keyword(s):  
Predictive Value ◽  
Neutralizing Antibodies ◽  
Immune Status ◽  
Point Of Care ◽  
Reference Standard ◽  
Antibody Testing ◽  
Point Of Care Test ◽  
Specific Pathogen ◽  
Privately Owned ◽  
Positive Results

(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.

scholarly journals Validation of the SavvyCheckTM Vaginal Yeast Test for Screening Pregnant Women for Vulvovaginal Candidosis: A Prospective, Cross-Sectional Study

2021 ◽  
Vol 7 (3) ◽  
pp. 233
Author(s):  
Philipp Foessleitner ◽  
Herbert Kiss ◽  
Julia Deinsberger ◽  
Julia Ott ◽  
Lorenz Zierhut ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Predictive Value ◽  
Point Of Care ◽  
Cross Sectional Study ◽  
Control Group ◽  
Gram Stain ◽  
Cross Sectional ◽  
Point Of Care Test ◽  
Increased Risk ◽  
Vulvovaginal Candidosis

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.

scholarly journals High Percentage of False-Positive Results for Influenza B Obtained With a Rapid Influenza Point-of-Care Test

2014 ◽  
Vol 59 (4) ◽  
pp. 604-605 ◽  
Author(s):  
N. M. Iovine ◽  
T. Ison ◽  
T. Payton ◽  
J. G. Morris ◽  
K. Rand
Keyword(s):  
False Positive ◽  
Point Of Care ◽  
Influenza B ◽  
Point Of Care Test ◽  
Positive Results

scholarly journals Accuracy of Rapid Point-of-Care Antibody Test in patients with suspected or confirmed COVID-19

2020 ◽  
Author(s):  
Rama Vancheeswaran ◽  
Merlin L Willcox ◽  
Beth Stuart ◽  
Matthew Knight ◽  
Hala Kandil ◽  
...  
Keyword(s):  
Point Of Care ◽  
Antibody Test ◽  
Reference Laboratory ◽  
List Type ◽  
Reference Standard ◽  
Point Of Care Test ◽  
History Of ◽  
Antibody Tests ◽  
Composite Reference Standard ◽  
Rapid Antibody

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.

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.

scholarly journals Diagnostic accuracy of dynamic ultrasound imaging in partial and complete anterior cruciate ligament tears: a retrospective study in 247 patients

2019 ◽  
Vol 5 (1) ◽  
pp. e000605 ◽  
Author(s):  
Manon Breukers ◽  
Dorieke Haase ◽  
Stephan Konijnenberg ◽  
Tiburtius V S Klos ◽  
Geert-Jan Dinant ◽  
...  
Keyword(s):  
Anterior Cruciate Ligament ◽  
Diagnostic Accuracy ◽  
Predictive Value ◽  
Point Of Care ◽  
Cruciate Ligament ◽  
Multivariate Regression Analysis ◽  
Point Of Care Test ◽  
Dynamic Ultrasound ◽  
Anterior Cruciate ◽  
Knee Pathology

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.

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 Commercial Laboratory IgM Testing forToxoplasma gondiiin Pregnancy: A 20-Year Experience

2005 ◽  
Vol 13 (3) ◽  
pp. 151-153 ◽  
Author(s):  
David J. Garry ◽  
Andrew Elimian ◽  
Vandy Wiencek ◽  
David A. Baker
Keyword(s):  
Predictive Value ◽  
False Positive ◽  
False Positive Rate ◽  
Reference Laboratory ◽  
Antibody Testing ◽  
Commercial Laboratory ◽  
Laboratory Results ◽  
Positive Rate ◽  
Acute Toxoplasmosis ◽  
Positive Results

Objective.This study was performed to review the clinical utility of commercial laboratoryToxoplasmosis-specific IgM testing during pregnancy and outcomes of the gestation at our institution.Methods.A retrospective review of all women referred for suspected acuteToxoplasma gondiiinfection during pregnancy from 1984 through 2004 was performed. Women were diagnosed with suspected acute toxoplasmosis based on commercial laboratory serologic antibody testing. All women had blood sent to a recognized reference laboratory for antibody testing within 2 weeks of the commercial laboratory results. The study protocol was approved by the Institutional Review Board. Chi-square analysis were used with a significance ofP< .05.Results.A total of 130 women were evaluated during the study period with 116 IgM positive results from the commercial laboratories. The commercial laboratory antibodies were as follows: IgM positive with IgG negative (n= 20), IgM positive with IgG positive (n= 96), and IgM negative with IgG positive (n= 14). There was a significant reduction in the IgM positive results when comparing commercial laboratory (n= 116) with the reference laboratory results (n= 28;p< .001). Acute toxoplasmosis infection was diagnosed in 7 (5%) of the women. All cases of acute toxoplasmosis infection had a positive commercial laboratory IgM result. The false positive rate for the commercial laboratory IgM was 88.6% and the diagnostic indices were sensitivity 100%, specificity 11.4%, positive predictive value 6% and negative predictive value 100%.Conclusion.Commercial laboratoryToxoplasmosis-specific IgM is associated with a high false positive rate. The commercial and reference laboratory IgM results identified all cases of acute toxoplasmosis infection. Commercial laboratories reflexively obtaining reference laboratory confirmation of positive results could reduce costs associated with testing, referrals, retesting, and invasive procedures.

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 ◽  
...  
Keyword(s):  
At Risk ◽  
Predictive Value ◽  
Point Of Care ◽  
Field Performance ◽  
Antibody Test ◽  
Screening Strategy ◽  
Test Characteristics ◽  
Point Of Care Test ◽  
Sti Testing ◽  
At Risk Populations

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.

Diagnostic evaluation of the BD Affirm VPIII assay as a point-of-care test for the diagnosis of bacterial vaginosis, trichomoniasis and candidiasis

2020 ◽  
Vol 31 (4) ◽  
pp. 303-311
Author(s):  
Fazana Dessai ◽  
Makandwe Nyirenda ◽  
Motshedisi Sebitloane ◽  
Nathlee Abbai
Keyword(s):  
Bacterial Vaginosis ◽  
Predictive Value ◽  
Trichomonas Vaginalis ◽  
Point Of Care ◽  
Candida Spp ◽  
Vaginal Infections ◽  
Sexually Transmitted ◽  
Point Of Care Test ◽  
Mother And Child ◽  
Sensitivity Specificity

Untreated sexually transmitted infections and bacterial vaginosis (BV) pose a serious health risk to mother and child. Limited data exist on the use of the BD Affirm™ VPIII assay as a point-of-care test (POCT). The performance of the BD Affirm™ VPIII assay was compared with the BD Max™ vaginal assay for the diagnosis of BV, Trichomonas vaginalis (TV) and Candida spp. A total of 273 pregnant women were enrolled in this study and had provided two self-collected vaginal swabs. Sensitivity, specificity, positive predictive value, negative predictive value and prevalence were calculated. The prevalence of BV, candidiasis and trichomoniasis was 49.4, 57.2 and 10.3%, respectively. The BD Affirm™ VPIII assay showed a moderate sensitivity (79.8%) and a moderate specificity (80.3%) for diagnosing BV in all participants. The BD Affirm™ VPIII assay had an excellent specificity for Candida spp. and TV of 97.4 and 100%, respectively; however, the assay exhibited poor sensitivities of 52.9 and 46.4%, respectively. This study was the first to report on the performance of the BD Affirm™ VPIII assay as a POCT in an antenatal population. The assay was found to be unsuitable as a screening test for vaginal infections in pregnancy.

scholarly journals Clinical Utility of a Highly Sensitive Lateral Flow Immunoassay as determined by Titer Analysis for the Detection of anti-SARS-CoV-2 Antibodies at the Point-of-Care

2020 ◽  
Author(s):  
Amanda Haymond ◽  
Claudius Mueller ◽  
Hannah Steinberg ◽  
K. Alex Hodge ◽  
Caitlin W Lehman ◽  
...  
Keyword(s):  
Neutralizing Antibodies ◽  
Best Practice ◽  
Point Of Care ◽  
Neutralization Assay ◽  
Lateral Flow ◽  
Lateral Flow Immunoassay ◽  
Enzyme Linked Immunosorbent Assay ◽  
Antibody Testing ◽  
Roc Curve Analysis ◽  
Viral Neutralization

Coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), became a pandemic in early 2020. Lateral flow immunoassays for antibody testing have been viewed as a cheap and rapidly deployable method for determining previous infection with SARS-CoV-2; however, these assays have shown unacceptably low sensitivity. We report on nine lateral flow immunoassays currently available and compare their titer sensitivity in serum to a best-practice enzyme-linked immunosorbent assay (ELISA) and viral neutralization assay. For a small group of PCR-positive, we found two lateral flow immunoassay devices with titer sensitivity roughly equal to the ELISA; these devices were positive for all PCR-positive patients harboring SARS-CoV-2 neutralizing antibodies. One of these devices was deployed in Northern Italy to test its sensitivity and specificity in a real-world clinical setting. Using the device with fingerstick blood on a cohort of 27 hospitalized PCR-positive patients and seven hospitalized controls, ROC curve analysis gave AUC values of 0.7646 for IgG. For comparison, this assay was also tested with saliva from the same patient population and showed reduced discrimination between cases and controls with AUC values of 0.6841 for IgG. Furthermore, during viral neutralization testing, one patient was discovered to harbor autoantibodies to ACE2, with implications for how immune responses are profiled. We show here through a proof-of-concept study that these lateral flow devices can be as analytically sensitive as ELISAs and adopted into hospital protocols; however, additional improvements to these devices remain necessary before their clinical deployment.

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