scholarly journals Diagnostic performance of the noninvasive prenatal FetoGnost RhD assay for the prediction of the fetal RhD blood group status

Author(s):  
Tobias J. Legler ◽  
Sandra Lührig ◽  
Irina Korschineck ◽  
Dieter Schwartz

Abstract Purpose To evaluate the diagnostic accuracy of a commercially available test kit for noninvasive prenatal determination of the fetal RhD status (NIPT-RhD) with a focus on early gestation and multiple pregnancies. Methods The FetoGnost RhD assay (Ingenetix, Vienna, Austria) is routinely applied for clinical decision making either in woman with anti-D alloimmunization or to target the application of routine antenatal anti-D prophylaxis (RAADP) to women with a RhD positive fetus. Based on existing data in the laboratory information system the newborn’s serological RhD status was compared with NIPT RhD results. Results Since 2009 NIPT RhD was performed in 2968 pregnant women between weeks 5 + 6 and 40 + 0 of gestation (median 12 + 6) and conclusive results were obtained in 2888 (97.30%) cases. Diagnostic accuracy was calculated from those 2244 (77.70%) cases with the newborn’s serological RhD status reported. The sensitivity of the FetoGnost RhD assay was 99.93% (95% CI 99.61–99.99%) and the specificity was 99.61% (95% CI 98.86–99.87%). No false-positive or false-negative NIPT RhD result was observed in 203 multiple pregnancies. Conclusion NIPT RhD results are reliable when obtained with FetoGnost RhD assay. Targeted routine anti-D-prophylaxis can start as early as 11 + 0 weeks of gestation in singleton and multiple pregnancies.

2021 ◽  
Author(s):  
Tobias J. Legler ◽  
Sandra Lührig ◽  
Irina Korschineck ◽  
Dieter Schwartz

Abstract Purpose: To evaluate the diagnostic accuracy of a commercially available test kit for noninvasive prenatal determination of the fetal RhD status (NIPT-RhD) with a focus on early gestation and multiple pregnancies. Methods: The FetoGnost RhD assay (Ingenetix, Vienna, Austria) is routinely applied for clinical decision making either in woman with anti-D alloimmunization or in order to target the application of routine antenatal anti-D prophylaxis (RAADP) to women with a RhD positive fetus. Based on existing data in the laboratory information system the newborn’s serological RhD status was compared with NIPT RhD results. Results: Since 2009 NIPT RhD was performed in 2,968 pregnant women between week 5+6 and 40+0 of gestation (median 12+6) and conclusive results were obtained in 2,888 (97.30%) cases. Diagnostic accuracy was calculated from those 2244 (77.70%) cases with the newborn’s serological RhD status reported. The sensitivity of the FetoGnost RhD assay was 99.93% (95% CI 99.61% - 99.99%) and the specificity was 99.61% (95% CI 98.86% - 99.87%). No false positive or false negative NIPT RhD result was observed in 203 multiple pregnancies. Conclusion: NIPT RhD results are reliable when obtained with FetoGnost RhD assay. Targeted routine anti-D-prophylaxis can start as early as 11+0 weeks of gestation in singleton and multiple pregnancies.


2020 ◽  
Vol 59 (06) ◽  
pp. 445-453
Author(s):  
Jens Kurth ◽  
Johannes Uhländer ◽  
Hamzeh Aladwan ◽  
Anna Göhrendt ◽  
Henriette Baier ◽  
...  

Abstract Aim Diagnosis of pulmonary embolism using V/P-SPECT may include the application of advanced image-processing techniques to identify V/P-mismatches. Aim of this study was to evaluate the benefit in clinical decision making in the diagnosis of pulmonary embolism.by whether adding to conventional reading a software that automatically calculates and visualizes the ventilation/perfusion-quotient pixel by pixel. Methods 63 consecutive patients with a clinical suspicion of PE who underwent V/P-SPECT were included in this retrospective study. Images were randomly ordered both for standard as well as for software-assisted reading using V/P-quotients. Studies were read independently by 2 experienced and 2 inexperienced raters. Diagnostic performance and observer agreement of all readers and both reading methods were determined. Results Expert observers consistently achieved a high diagnostic accuracy both in conventional as well as in software-assisted reporting (sensitivity: 0.94 vs. 0.94, specificity: 0.96 vs. 0.97, LR+: 17.32 vs. 28.86, LR– stayed constant at 0.06). For inexperienced readers, diagnostic performance improved: sensitivity raised from 0.74 to 0.85 and specificity from 0.86 to 0.95, LR+ raised from 5.20 to 15.69, LR– decreased from 0.31 to 0.16. Inter-rater reliability (Fleiss’ κ) improved from 0.63 to 0.86 by using V/P quotient. Conclusion Benefit from a software-tool that calculates V/P-ratio automatically is only small when used by experienced physicians If inexperienced readers use the software, the diagnostic accuracy increases. Images generated by automated calculation of V/P-mismatches are easy to read and their use might help to standardize and objectify interpretation of V/P-SPECT in the diagnosis of PE.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Carlos Alfonso Romero-Gameros ◽  
Tania Colin-Martínez ◽  
Salomón Waizel-Haiat ◽  
Guadalupe Vargas-Ortega ◽  
Eduardo Ferat-Osorio ◽  
...  

Abstract Background The SARS-CoV-2 pandemic continues to be a priority health problem; According to the World Health Organization data from October 13, 2020, 37,704,153 confirmed COVID-19 cases have been reported, including 1,079,029 deaths, since the outbreak. The identification of potential symptoms has been reported to be a useful tool for clinical decision-making in emergency departments to avoid overload and improve the quality of care. The aim of this study was to evaluate the performances of symptoms as a diagnostic tool for SARS -CoV-2 infection. Methods An observational, cross-sectional, prospective and analytical study was carried out, during the period of time from April 14 to July 21, 2020. Data (demographic variables, medical history, respiratory and non-respiratory symptoms) were collected by emergency physicians. The diagnosis of COVID-19 was made using SARS-CoV-2 RT-PCR. The diagnostic accuracy of these characteristics for COVID-19 was evaluated by calculating the positive and negative likelihood ratios. A Mantel-Haenszel and multivariate logistic regression analysis was performed to assess the association of symptoms with COVID-19. Results A prevalence of 53.72% of SARS-CoV-2 infection was observed. The symptom with the highest sensitivity was cough 71%, and a specificity of 52.68%. The symptomatological scale, constructed from 6 symptoms, obtained a sensitivity of 83.45% and a specificity of 32.86%, taking ≥2 symptoms as a cut-off point. The symptoms with the greatest association with SARS-CoV-2 were: anosmia odds ratio (OR) 3.2 (95% CI; 2.52–4.17), fever OR 2.98 (95% CI; 2.47–3.58), dyspnea OR 2.9 (95% CI; 2.39–3.51]) and cough OR 2.73 (95% CI: 2.27–3.28). Conclusion The combination of ≥2 symptoms / signs (fever, cough, anosmia, dyspnea and oxygen saturation < 93%, and headache) results in a highly sensitivity model for a quick and accurate diagnosis of COVID-19, and should be used in the absence of ancillary diagnostic studies. Symptomatology, alone and in combination, may be an appropriate strategy to use in the emergency department to guide the behaviors to respond to the disease. Trial registration Institutional registration R-2020-3601-145, Federal Commission for the Protection against Sanitary Risks 17 CI-09-015-034, National Bioethics Commission: 09 CEI-023-2017082.


2018 ◽  
Vol 11 (5) ◽  
pp. 321-331
Author(s):  
Cody Davis ◽  
Jenna Immormino ◽  
Brendan M Higgins ◽  
Kyle Clark ◽  
Samuel Engebose ◽  
...  

Background The Active Compression Test has been proposed to have high diagnostic accuracy for superior labrum anterior to posterior tears. The aim of this systematic review was to compile the available evidence for this test and evaluate its diagnostic accuracy. Methods The databases PubMed, Embase, Cochrane, CINAHL, and SCOPUS were searched for case control, diagnostic studies that evaluated the Active Compression Test between 1999 (date of test introduction) and February 2018. Two independent review authors screened the search results, assessed the risk of bias using QUADAS-2, and extracted the data. Results Eighteen studies (pooled sample = 3091) were included in this review. Twelve out of 18 studies either had high or unclear risk of bias (66.6%). Results from the pooled analysis of all 18 studies provided that the Active Compression Test is more sensitive (71.5: 95% CI = 68.8, 74.0) than specific (51.9: 95% CI = 50.7, 53.1) and only marginally influenced posttest probability from a pretest probability of 31.7–40.72% with a positive finding and a pretest probability of 31.7–20.33% with a negative finding. Discussion The Active Compression Test has both limited screening and confirmation ability; therefore, we do not advocate for its use in clinical decision making.


2019 ◽  
Vol 41 (03) ◽  
pp. 308-316 ◽  
Author(s):  
Eckhart Fröhlich ◽  
Katharina Beller ◽  
Reinhold Muller ◽  
Maria Herrmann ◽  
Ines Debove ◽  
...  

Abstract Purpose The aim of the current study was to evaluate point of care ultrasound (POCUS) in geriatric patients by echoscopy using a handheld ultrasound device (HHUSD, VScan) at bedside in comparison to a high-end ultrasound system (HEUS) as the gold standard. Materials and Methods Prospective observational study with a total of 112 geriatric patients. The ultrasound examinations were independently performed by two experienced blinded examiners with a portable handheld device and a high-end ultrasound device. The findings were compared with respect to diagnostic findings and therapeutic implications. Results The main indications for the ultrasound examinations were dyspnea (44.6 %), fall (frailty) (24.1 %) and fever (21.4 %). The most frequently found diagnoses were cystic lesions 32.1 % (35/109), hepatic vein congestion 19.3 % (21/109) and ascites 13.6 % (15/110). HHUSD delivered 13 false-negative findings in the abdomen resulting in an “overall sensitivity” of 89.5 %. The respective “overall specificity” was 99.6 % (7 false-positive diagnoses). HHUSD (versus HEUS data) resulted in 13.6 % (17.3 %) diagnostically relevant procedures in the abdomen and 0.9 % (0.9 %) in the thorax. Without HHUSD (HEUS) 95.7 % (100 %) of important pathological findings would have been missed. Conclusion The small HHUSD tool improves clinical decision-making in immobile geriatric patients at the point of care (geriatric ward). In most cases, HHUSD allows sufficiently accurate yes/no diagnoses already at the bedside, thereby clarifying the leading symptoms for early clinical decision-making.


2013 ◽  
Vol 04 (02) ◽  
pp. 212-224 ◽  
Author(s):  
M. Kashiouris ◽  
J.C. O’Horo ◽  
B.W. Pickering ◽  
V. Herasevich

SummaryContext: Healthcare Electronic Syndromic Surveillance (ESS) is the systematic collection, analysis and interpretation of ongoing clinical data with subsequent dissemination of results, which aid clinical decision-making.Objective: To evaluate, classify and analyze the diagnostic performance, strengths and limitations of existing acute care ESS systems.Data Sources: All available to us studies in Ovid MEDLINE, Ovid EMBASE, CINAHL and Scopus databases, from as early as January 1972 through the first week of September 2012.Study Selection: Prospective and retrospective trials, examining the diagnostic performance of inpatient ESS and providing objective diagnostic data including sensitivity, specificity, positive and negative predictive values.Data Extraction: Two independent reviewers extracted diagnostic performance data on ESS systems, including clinical area, number of decision points, sensitivity and specificity. Positive and negative likelihood ratios were calculated for each healthcare ESS system. A likelihood matrix summarizing the various ESS systems performance was created.Results: The described search strategy yielded 1639 articles. Of these, 1497 were excluded on abstract information. After full text review, abstraction and arbitration with a third reviewer, 33 studies met inclusion criteria, reporting 102,611 ESS decision points. The yielded I2 was high (98.8%), precluding meta-analysis. Performance was variable, with sensitivities ranging from 21% –100% and specificities ranging from 5%-100%.Conclusions: There is significant heterogeneity in the diagnostic performance of the available ESS implements in acute care, stemming from the wide spectrum of different clinical entities and ESS systems. Based on the results, we introduce a conceptual framework using a likelihood ratio matrix for evaluation and meaningful application of future, frontline clinical decision support systems.Citation: Kashiouris M, O’Horo JC, Pickering BW, Herasevich V. Diagnostic performance of electronic syndromic surveillance systems in acute care – a systematic review. Appl Clin Inf 2013; 4: 212–224http://dx.doi.org/10.4338/ACI-2012-12-RA-0053


2014 ◽  
Vol 13 (1) ◽  
pp. e392
Author(s):  
T. Kwon ◽  
I.G. Jeong ◽  
D. You ◽  
B. Lim ◽  
K-S. Han ◽  
...  

2017 ◽  
Vol 10 (3) ◽  
pp. S50
Author(s):  
Christopher Cook ◽  
Ricardo Petraco ◽  
Yousif Ahmad ◽  
Matthew Shun-Shin ◽  
Sukhjinder Nijjer ◽  
...  

Author(s):  
Matthijs Oyaert ◽  
An Boel ◽  
Julie Jacobs ◽  
Stefanie Van den Bremt ◽  
Maxime De Sloovere ◽  
...  

AbstractBackground:We evaluated the analytical performance of six different faecal calprotectin immunoassays together with their diagnostic accuracy in the discrimination between functional and organic bowel disorders.Methods:The faecal samples were obtained from inflammatory bowel disease patients (n=27) at the time of diagnosis [Crohn’s disease (n=15), colitis ulcerosa (n=12)], gastroenterologic disease control patients (n=52) and rheumatologic disease control patients (n=26). All individuals included in the study underwent a concurrent ileocolonoscopy. Analytical performance (imprecision, accuracy, carry-over, correlation and agreement) and diagnostic accuracy (sensitivity, specificity, likelihood ratios) of the different assays were evaluated.Results:All methods demonstrated good analytical performance, but within-run and total imprecision varied depending on the assay methodology used. Using Passing Bablok and Bland-Altman analyses, low quantitative agreement was observed between the assays. All assays showed excellent diagnostic accuracy, with areas under the receiver operating characteristic curves (ROC) ranging from 0.974 to 0.998. The AUCs were not significantly different between assays (p>0.05). Diagnostic sensitivity at the cut-off at a fixed specificity of 75% ranged from 95.2% to 100%. Introduction of multiple result intervals increased the clinical interpretation of all the assays.Conclusions:Analytical and diagnostic performance of the evaluated faecal calprotectin assays is good, but numerical values differ substantially between the assays necessitating the use of different clinical cut-offs. Introduction of multiple result intervals aids in clinical decision-making.


Sign in / Sign up

Export Citation Format

Share Document