Comparison of hysterosalpingo-foam sonography vs. hysterosalpingography: a prospective observational study.
Comparison of hysterosalpingo-foam sonography vs. hysterosalpingography: a prospective observational study.
- Research Article
2
- 10.1111/bju.16714
- Mar 26, 2025
- BJU international
To evaluate the impact of discordant histological diagnoses between transurethral resection of bladder tumour (TURBT) and radical cystectomy (RC) on cancer-specific mortality (CSM) in patients with bladder cancer (BCa). We relied on a multi-institutional database collecting data of patients with BCa who underwent TURBT and subsequent RC from nine centres between 2000 and 2023. We tested concordance rates between TURBT and RC in detecting urothelial carcinoma of the urinary bladder (UCUB) as well as non-UCUB hystological subtypes, using RC as the reference standard. Concordance was defined as the agreement between a specific histological subtype identified both at TURBT and RC and evaluated according to Cohen's kappa coefficient. Subsequently, survival analyses consisted of Kaplan-Meier plots and multivariable Cox regression (MCR) models addressing CSM according to concordance between TURBT and RC (namely, concordant vs discordant). Overall, 3160 patients were identified. Of these, 2762 (87%) harboured UCUB and 398 (13%) non-UCUB at TURBT vs 2481 (79%) UCUB and 679 (21%) non-UCUB at RC. There were 683 (21.6%) patients with a discordant diagnosis between TURBT and RC. The overall concordance in detecting non-UCUB subtypes was defined as fair concordance (Cohen's kappa coefficient: 0.32). In MCR models, a discordant diagnosis exhibited higher CSM relative to those with a concordant diagnosis (hazard ratio [HR] 1.3, 95% confidence interval [CI] 1.1-1.6; P = 0.002). In a sensitivity analysis including patients with UCUB not exposed to neoadjuvant chemotherapy, this survival disadvantage was even higher (HR 1.5, 95% CI 1.1-1.7; P = 0.04). A discordant histopathological diagnosis between TURBT and RC is associated with higher CSM rates, particularly in cases initially misdiagnosed as UCUB. However, we also observed a moderate concordance between TURBT and RC in identifying non-UCUB subtypes.
- Research Article
- 10.7759/cureus.108517
- May 1, 2026
- Cureus
Background Hysteroscopy is widely regarded as the gold standard for the evaluation of intrauterine pathology due to its ability to provide direct visualization of the endometrium. In patients with suspected endometrial disease, the primary clinical objective is to exclude malignancy and identify premalignant precursor lesions such as endometrial intraepithelial neoplasia (EIN). However, the diagnostic performance of visual hysteroscopic impression compared to histopathology remains variable. This study aimed to assess the diagnostic accuracy and concordance between hysteroscopic findings and histopathological results in a tertiary care center in Mexico. Methods An observational, cross-sectional, retrospective analytical study was conducted, including 397 patients who underwent hysteroscopy between January 2024 and December 2025. The surgeon's visual impression (index test) was compared with the histopathological diagnosis obtained from directed biopsy (reference standard). Diagnostic performance was evaluated through sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Concordance between both methods was assessed using Cohen's kappa coefficient. Results The mean age of the study population was 48.8 years, and 36.3% were postmenopausal. Hysteroscopic findings suggested malignancy in 9.8% of cases. A total of 41 patients were identified with high-risk endometrial pathology, including endometrial hyperplasia and EIN/atypical endometrial hyperplasia (AEH). Hysteroscopy demonstrated a sensitivity of 60.97% and a specificity of 96.06%. The PPV was 64.1%, while the NPV reached 95.53%. The Cohen's kappa coefficient was 0.541, indicating moderate agreement between hysteroscopic impression and histopathological findings. Conclusions Hysteroscopy is a valuable diagnostic tool for excluding high-risk endometrial pathology, given its high specificity and NPV. However, its moderate sensitivity limits its reliability for definitive diagnosis of premalignant and malignant lesions. These findings highlight the necessity of performing directed biopsies for histopathological confirmation, particularly in cases with suspicious visual findings.
- Research Article
35
- 10.1093/humrep/deac034
- Feb 27, 2022
- Human Reproduction (Oxford, England)
STUDY QUESTIONDoes hysterosalpingo-foam sonography (HyFoSy) lead to similar pregnancy outcomes, compared with hysterosalpingography (HSG), as first-choice tubal patency test in infertile couples?SUMMARY ANSWERHyFoSy and HSG produce similar findings in a majority of patients and clinical management based on the results of either HyFoSy or HSG, leads to comparable pregnancy outcomes. HyFoSy is experienced as significantly less painful.WHAT IS KNOWN ALREADYTraditionally, tubal patency testing during fertility work-up is performed by HSG. HyFoSy is an alternative imaging technique lacking ionizing radiation and iodinated contrast medium exposure which is less expensive than HSG. Globally, there is a shift towards the use of office-based diagnostic methods, such as HyFoSy.STUDY DESIGN, SIZE, DURATIONThis multicentre, prospective, comparative study with a randomized design was conducted in 26 hospitals in The Netherlands. Participating women underwent both HyFoSy and HSG in randomized order. In case of discordant results, women were randomly allocated to either a management strategy based on HyFoSy or one based on HSG.PARTICIPANTS/MATERIALS, SETTING, METHODSWe included infertile women between 18 and 41 years old who were scheduled for tubal patency testing during their fertility work-up. Women with anovulatory cycles not responding to ovulation induction, endometriosis, severe male infertility or a known iodine contrast allergy were excluded. The primary outcome for the comparison of the HyFoSy- and HSG-based strategies was ongoing pregnancy leading to live birth within 12 months after inclusion in an intention-to-treat analysis.MAIN RESULTS AND THE ROLE OF CHANCEBetween May 2015 and January 2019, 1026 women underwent HyFoSy and HSG. HyFoSy was inconclusive in 97 of them (9.5%), HSG was inconclusive in 30 (2.9%) and both were inconclusive in 9 (0.9%). In 747 women (73%) conclusive tests results were concordant. Of the 143/1026 (14%) with discordant results, 105 were randomized to clinical management based on the results of either HyFoSy or HSG. In this group, 22 of the 54 women (41%) allocated to management based on HyFoSy and 25 of 51 women (49%) allocated to management based on HSG had an ongoing pregnancy leading to live birth (Difference −8%; 95% CI: −27% to 10%). In total, clinical management based on the results of HyFoSy was estimated to lead to a live birth in 474 of 1026 women (46%) versus 486 of 1026 (47%) for management based on HSG (Difference −1.2%; 95% CI: −3.4% to 1.5%). Given the pre-defined margin of −2%, statistically significant non-inferiority of HyFoSy relative to HSG could not be demonstrated (P = 0.27). The mean pain score for HyFoSy on the 1–10 Visual Analogue Scale (VAS) was 3.1 (SD 2.2) and the mean VAS pain score for HSG was 5.4 (SD 2.5; P for difference < 0.001).LIMITATIONS, REASONS FOR CAUTIONSince all women underwent both tubal patency tests, no conclusions on a direct therapeutic effect of tubal flushing could be drawn.WIDER IMPLICATIONS OF THE FINDINGSHyFoSy or HSG produce similar tubal pathology findings in a majority of infertile couples and, where they differ, a difference in findings does not lead to substantial difference in pregnancy outcome, while HyFoSy is associated with significantly less pain.STUDY FUNDING/COMPETING INTEREST(S)The FOAM study was an investigator-initiated study funded by ZonMw, The Netherlands organization for Health Research and Development (project number 837001504). ZonMw funded the whole project. IQ Medical Ventures provided the ExEm-foam® kits free of charge. The funders had no role in study design, collection, analysis and interpretation of the data. K.D. reports travel and speaker fees from Guerbet. F.J.M.B. reports personal fees as a member of the external advisory board for Merck Serono, The Netherlands, and a research support grant from Merck Serono, outside the submitted work. C.B.L. reports speakers’ fee from Ferring in the past, and his department receives research grants from Ferring, Merck and Guerbet. J.S. reports a research agreement with Takeda on MR of motility outside the submitted work. M.V.W. reports leading The Netherlands Satellite of the Cochrane Gynaecology and Fertility Group. B.W.J.M. is supported by an NHMRC Investigator grant (GNT1176437). B.W.J.M. reports consultancy for Guerbet and research funding from Merck and Guerbet. V.M. reports non-financial support from IQ medicals ventures, during the conduct of the study; grants and personal fees from Guerbet, outside the submitted work. The other authors do not report conflicts of interest.TRIAL REGISTRATION NUMBERNTR4746/NL4587 (https://www.trialregister.nl)TRIAL REGISTRATION DATE19 August 2014DATE OF FIRST PATIENT’S ENROLMENT7 May 2015
- Research Article
43
- 10.3389/fimmu.2019.00376
- Mar 5, 2019
- Frontiers in Immunology
Background: Is it well-known that one of the major drawbacks of Lupus Anticoagulant (LA) test is their sensitivity to anticoagulant therapy, due to the coagulation based principle. In this study we aimed to assess the reproducibility of LA testing and to evaluate the performance of solid assay phosphatidylserine/prothrombin (aPS/PT) antibodies.Methods: We included 60 patients that fulfilled the following inclusion criteria: (I) diagnosis of thrombotic antiphospholipid syndrome (APS); (II) patients with thrombosis and (a) inconstant previous LA positivity and/or (b) positivity for antiphospholipid antibodies (aPL) at low-medium titers [defined as levels of anti-β2Glycoprotein-I or anticardiolipin (IgG/IgM) 10–30 GPL/MPL] with no previous evidence of LA positivity. aPL testing was performed blindly in 4 centers undertaking periodic external quality assessment.Results: The 60 patients enrolled were distributed as follows: 43 (71.7%) with thrombotic APS, 7 (11.7%) with thrombosis and inconstant LA positivity and 10 (16.7%) with low-medium aPL titers. Categorical agreement for LA among the centers ranged from 0.41 to 0.60 (Cohen's kappa coefficient; moderate agreement). The correlation determined at the 4 sites for aPS/PT was strong, both quantitatively (Spearman rho 0.84) and when dichotomized (Cohen's kappa coefficients = 0.81 to 1.0). Discordant (as defined by lack of agreement in ≥3 laboratories) or inconclusive LA results were observed in 27/60 (45%) cases; when limiting the analysis to those receiving vitamin K antagonist (VKA), the level of discordant LA results was as high as 75%(15/20). Conversely, aPS/PT testing showed an overall agreement of 83% (up to 90% in patients receiving VKA), providing an overall increase in test reproducibility of +28% when compared to LA, becoming even more evident (+65%) when analyzing patients on VKA. In patients treated with VKA, we observed a good correlation for aPS/PT IgG testing (Cohen's kappa coefficients = 0.81–1; Spearman rho 0.86).Conclusion: Despite the progress in the standardization of aPL testing, we observed up to 45% of overall discrepant results for LA, even higher in patients on VKA. The introduction of aPS/PT testing might represent a further diagnostic tool, especially when LA testing is not available or the results are uncertain.
- Research Article
51
- 10.1016/j.fertnstert.2014.05.042
- Jul 1, 2014
- Fertility and Sterility
Hysterosalpingo-foam sonography, a less painful procedure for tubal patency testing during fertility workup compared with (serial) hysterosalpingography: a randomized controlled trial
- Research Article
20
- 10.1055/s-2007-1000507
- May 16, 2008
- Ultraschall in der Medizin
Evaluation of tubal patency is usually assessed with hysterosalpingography (HSG) or laparoscopy including chromopertubation. Sonographical visualisation with Echovist 200 (hysterosalpingo-contrast sonography-HyCoSy) provides a new noninvasive tool. Therefore we conducted a prospective controlled study to compare sonographic and radiological evaluation of the fallopian tube. Main test parameters were accuracy of both methods and patient discomfort. 50 patients were enrolled in this study. All patients were examined by both techniques; the sequence was randomly chosen. The results of HSG and HyCoSy were compared. Patient discomfort was assessed with a standardised questionnaire using a visual analog scale (0-10). Diagnosis of tubal patency identifying proximal or distal blockage was the primary end point using HSG as standard technique. Proximal and distal patency by HSG was sonographically confirmed in 82.9% (63/76) and 82.1% (46/56) tubes respectively. If HSG revealed proximal or distal occlusion, identical results were obtained in 91.7% (22/24) or 60% (12/20) by HyCoSy. No significant differences were found in patient discomfort. However a significant correlation was demonstrated between tubal patency and discomfort. The lowest score was obtained in patients with open tubes (4.6) increased in patients with distal occlusion (6.0) and reached a maximum with proximal pathology (8.7). Compared to conventional HSG, HyCoSy provides a highly efficient evaluation of tubal pathology and can be successfully used as a noninvasive screening method.
- Research Article
31
- 10.1046/j.1469-0705.2002.00823.x
- Oct 1, 2002
- Ultrasound in Obstetrics & Gynecology
Experimental and clinical data suggest that insonation of echo-enhancing contrast agents with high acoustic power produces disintegration of microbubbles, resulting in a phenomenon called stimulated acoustic emission (SAE). The purpose of this study was to investigate whether SAE might be detected by transvaginal sonography and whether this technique may be useful in the assessment of tubal patency by hysterosalpingo-contrast sonography (SAE-HyCoSy). Patients booked for X-ray hysterosalpingography (HSG) for infertility evaluation also received SAE-HyCoSy. The order of the two procedures was established in each patient by randomization after placement of a transcervical balloon catheter. For SAE-HyCoSy, the ultrasound contrast medium Levovist was injected, with the acoustic power set at the maximum level permitted on ultrasound machines employing dedicated algorithms. Conventional HSG was performed for comparison. Seventy-seven Fallopian tubes were examined in 41 patients. In all cases it was possible to obtain the SAE phenomenon. In 10 tubes (13%) proximal filling was not observed by both SAE-HyCoSy and HSG. In the remaining 67 tubes, free spill from the distal end of the lumen was demonstrated in 96% of cases (64/67) with SAE-HyCoSy and in 97% of cases (65/67) with HSG. Disagreement between the two techniques was observed in five tubes only, with a Cohen's kappa coefficient of 0.76 (95% confidence interval, 0.56-0.96). SAE techniques were successfully applied to HyCoSy and allowed the visualization of the free spill of contrast agent into the peritoneal cavity in the majority of cases. SAE-HyCoSy showed good agreement with HSG in this preliminary study.
- Research Article
35
- 10.1002/uog.11132
- Nov 1, 2012
- Ultrasound in Obstetrics & Gynecology
To evaluate the visibility of cesarean section (CS) scars by transvaginal sonography (TVS) in pregnant women, to apply a standardized approach for measuring CS scars and to test its reproducibility throughout the course of pregnancy. In this observational cohort study, 320 consecutive pregnant women with a previous cesarean delivery were examined to assess scar visibility by two independent examiners. TVS was carried out at 11-13, 19-21 and 34-36 weeks' gestation. A scar was defined as visible when an area of hypoechogenicity representing myometrial discontinuity at the anterior wall of the lower uterine segment was identified. In a subset of patients (n = 111), visible scars were measured by two independent examiners in three dimensions: scar width, depth and length as well as the residual myometrial thickness (RMT). Descriptive analysis was used to assess scar visibility, and the intraclass correlation coefficient (ICC) was calculated to show the strength of absolute agreement between two examiners for scar measurements. For RMT, a cut-off of 2.4 mm was used and measurement agreement was assessed using Cohen's kappa coefficient. The scar was visible in 284/320 cases (88.8%). Visible scars were significantly associated with anteverted uteri (P < 0.0001). Both examiners had 100% agreement on scar visibility at 12 and 20 weeks' gestation, while agreement was 96% at 34 weeks. The intra- and interobserver agreements for scar measurements were generally good (ICC 0.86 and 0.89, respectively). The kappa coefficient for the RMT was 0.27 in the first trimester, compared with 0.51 and 0.72 in the second and third trimesters, respectively. CS scars remain visible in the majority of women throughout pregnancy. They can be reproducibly measured in three dimensions when assessed by TVS in all trimesters of pregnancy. The agreement between two observers for CS scar measurement can be considered good for the first trimester, compared with relatively moderate agreement for the second and third trimesters.
- Research Article
34
- 10.1186/s12905-018-0556-6
- May 9, 2018
- BMC Women's Health
BackgroundTubal pathology is a causative factor in 20% of subfertile couples. Traditionally, tubal testing during fertility work-up is performed by hysterosalpingography (HSG). Hysterosalpingo-foam sonography (HyFoSy) is a new technique that is thought to have comparable accuracy as HSG, while it is less expensive and more patient friendly. HyFoSy would be an acceptable alternative for HSG, provided it has similar effectiveness in terms of patient outcomes.Methods/designWe aim to compare the effectiveness and costs of management guided by HyFoSy or by HSG. Consenting women will undergo tubal testing by both HyFoSy and HSG in a randomized order during fertility work-up. The study group will consist of 1163 subfertile women between 18 and 41 years old who are scheduled for tubal patency testing during their fertility work-up. Women with anovulatory cycles not responding to ovulation induction, endometriosis, severe male subfertility or a known contrast (iodine) allergy will be excluded. We anticipate that 7 % (N = 82) of the participants will have discordant test results for HyFoSy and HSG. These participants will be randomly allocated to either a management strategy based on HyFoSy or a management strategy based on HSG, resulting in either a diagnostic laparoscopy with chromopertubation or a strategy that assumes tubal patency (intrauterine insemination or expectant management). The primary outcome is ongoing pregnancy leading to live birth within 12 months after randomization. Secondary outcomes are patient pain scores, time to pregnancy, clinical pregnancy, miscarriage rate, multiple pregnancy rate, preterm birth rate and number of additional treatments. Costs will be estimated by counting resource use and calculating unit prices.DiscussionThis trial will compare the effectiveness and costs of HyFoSy versus HSG in assessing tubal patency in subfertile women.Trial registrationDutch Trial Register (NTR 4746, http://www.trialregister.nl). Date of registration: 19 August 2014.
- Research Article
1
- 10.1093/humrep/deae194
- Aug 27, 2024
- Human Reproduction (Oxford, England)
STUDY QUESTIONDoes hysterosalpingo-foam sonography (HyFoSy) prior to hysterosalpingography (HSG) or HSG prior to HyFoSy affect visible tubal patency when compared HSG or HyFoSy alone?SUMMARY ANSWERUndergoing either HyFoSy or HSG prior to tubal patency testing by the alternative method does not demonstrate a significant difference in visible tubal patency when compared to HyFoSy or HSG alone.WHAT IS KNOWN ALREADYHyFoSy and HSG are two commonly used visual tubal patency tests with a high and comparable diagnostic accuracy for evaluating tubal patency. These tests may also improve fertility, although the underlying mechanism is still not fully understood. One of the hypotheses points to a dislodgment of mucus plugs that may have disrupted the patency of the Fallopian tubes.STUDY DESIGN, SIZE, DURATIONThis is a secondary analysis of the randomized controlled FOAM study, in which women underwent tubal patency testing by HyFoSy and HSG, randomized for order of the procedure. Participants either had HyFoSy first and then HSG, or vice versa. Here, we evaluate the relative effectiveness of tubal patency testing by HyFoSy or HSG prior to the alternative tubal patency testing method on visible tubal patency, compared to each method alone.PARTICIPANTS/MATERIALS, SETTING, METHODSInfertile women aged between 18 and 41 years scheduled for tubal patency testing were eligible for participating in the FOAM study. Women with anovulatory cycles, endometriosis, or with a partner with male infertility were excluded. To evaluate the effect HyFoSy on tubal patency, we relied on HSG results by comparing the proportion of women with bilateral tubal patency visible on HSG in those who underwent and who did not undergo HyFoSy prior to their HSG (HyFoSy prior to HSG versus HSG alone). To evaluate the effect of HSG on tubal patency, we relied on HyFoSy results by comparing the proportion of women with bilateral tubal patency visible on HyFoSy in those who underwent and who did not undergo HSG prior to their HyFoSy (HSG prior to HyFoSy versus HyFoSy alone).MAIN RESULTS AND THE ROLE OF CHANCEBetween May 2015 and January 2019, we randomized 1160 women (576 underwent HyFoSy first followed by HSG, and 584 underwent HSG first followed by HyFoSy). Among the women randomized to HyFoSy prior to HSG, bilateral tubal patency was visible on HSG in 467/537 (87%) women, compared with 472/544 (87%) women who underwent HSG alone (risk difference 0.2%; 95% CI: −3.8% to 4.2%). Among the women randomized to HSG prior to HyFoSy, bilateral tubal patency was visible on HyFoSy in 394/471 (84%) women, compared with 428/486 (88%) women who underwent HyFoSy alone (risk difference −4.4%; 95% CI: −8.8% to 0.0%).LIMITATIONS, REASONS FOR CAUTIONThe results of this secondary analysis should be interpreted as exploratory and cannot be regarded as definitive evidence. Furthermore, it has to be noted that pregnancy outcomes were not considered in this analysis.WIDER IMPLICATIONS OF THE FINDINGSTubal patency testing by either HyFoSy or HSG, prior to the alternative tubal patency testing method does not significantly affect visible tubal patency, when compared to alternative method alone. This suggests that both methods may have comparable abilities to dislodge mucus plugs in the Fallopian tubes.STUDY FUNDING/COMPETING INTEREST(S)The FOAM study was an investigator-initiated study, funded by ZonMw, a Dutch organization for Health Research and Development (project number 837001504). IQ Medical Ventures provided the ExEm®-FOAM kits free of charge. The funders had no role in study design, collection, analysis, or interpretation of the data. H.R.V. reports consultancy fees from Ferring. M.v.W. received a travel grant from Oxford University Press in the role of Deputy Editor for Human Reproduction and participates in a Data Safety and Monitoring Board as an independent methodologist in obstetrics studies in which she has no other role. M.v.W. is coordinating editor of Cochrane Fertility and Gynaecology. B.W.J.M. received an investigator grant from NHMRC (GNT1176437) and research funding from Merck KGaA. B.W.J.M. reports consultancy for Organon and Merck KGaA, and travel support from Merck KGaA. B.W.J.M. reports holding stocks of ObsEva. V.M. received research grants from Guerbet, Merck and Ferring and travel and speaker fees from Guerbet. The other authors do not report conflicts of interest.TRIAL REGISTRATION NUMBERInternational Clinical Trials Registry Platform No. NTR4746.
- Research Article
41
- 10.1016/j.jadohealth.2018.08.015
- Nov 3, 2018
- Journal of Adolescent Health
Parent and Adolescent Attitudes Towards Preventive Care and Confidentiality
- Research Article
1
- 10.1016/j.arcped.2005.04.004
- Apr 30, 2005
- Archives de pédiatrie
Adoption internationale : vision de deux pédiatres québécoises
- Research Article
38
- 10.2169/internalmedicine.51.6718
- Jan 1, 2012
- Internal Medicine
Anhedonia is one of the main non-motor symptoms in Parkinson's disease (PD); it is assessed using the Snaith-Hamilton pleasure scale (SHAPS). To assess anhedonia in the Japanese population, we prepared a Japanese language version of SHAPS (SHAPS-J), and evaluated its validity and reliability in 8 neurological centers. Seventy subjects (48 patients with PD and 22 healthy subjects) were enrolled in this study. The validity of the test was assessed by the correlation between SHAPS-J and the apathy scale, based on the fact that anhedonia is considered a symptom of apathy syndrome. Test-retest reliability and internal consistency were assessed by Cohen's kappa and Cronbach's alpha coefficients, respectively. In the evaluation of validity, the total scores obtained on SHAPS-J during the test and retest significantly correlated with scores on Item 4 in Part 1 of the unified Parkinson's disease rating scale (p<0.0008 and p<0.0036, respectively). Cohen's kappa coefficient was >0.3 on all items (p<0.0005 on all items). Cronbach's alpha coefficient was 0.90 at the baseline and 0.88 at the retest. These results indicate that SHAPS-J has good validity, test-retest reliability, and internal consistency, thus establishing an available measure of anhedonia in Japanese.
- Research Article
1
- 10.5937/bezbednost2303046p
- Jan 1, 2023
- Bezbednost, Beograd
Recidivism risk assessment in the penal system has significantly advanced, and today assessment instruments are in use that should contribute to more effective treatment of convicts. However, despite the efforts invested in the development and enhancement of the instruments, there are still certain problems in their application, which researchers and practitioners strive to eliminate or minimize. In accordance with the aforementioned, the aim of this paper is to examine the interrater reliability of the Questionnaire for Assessing Risk, Capacity and Needs of convicts in the prison system of the Republic of Serbia. The study was conducted in three penitentiaries (Požarevac, Sremska Mitrovica and Niš) on a sample of 54 convicted persons who were assessed as having a high or extremely high recidivism risk in the reception department and 35 employed professional staff members. The obtained data indicate a moderate agreement (0.637) measured by Cohen's Kappa coefficient, and an absolute agreement among of the evaluators in 88.9% of cases. On the other hand, absolute agreement of the evaluators, when looking at the recidivsm risk score, exists in only 7 cases. It was found that the largest number of items have a moderate agreement, as well as that the static recidivism risk factors were most consistently evaluated. The findings of our research show that the instrument has moderate rater agreement, on a sample of a high recidivism risk offenders, but also that there are certain problems that affect interobserver reliability.
- Research Article
22
- 10.1007/s10096-017-3083-8
- Aug 22, 2017
- European Journal of Clinical Microbiology & Infectious Diseases
Dengue virus is endemic in French Guiana with occurrence of cyclical outbreaks. There is a need for rapid tests allowing dengue laboratory diagnosis in healthcare centers scattered throughout this wide Amazonian territory. Our objective was to evaluate the real-life performance of the SD BIOLINE Dengue Duo (IgG/IgM+NS1 Ag) rapid test (RDT) during the 2012-2013 dengue epidemics. The RDT was evaluated in parallel with routine laboratory tests, PlateliaTM Dengue NS1 Ag and Focus Diagnostics Dengue Fever Virus IgM Capture DxSelect. A total of 3,347 patients with suspected dengue acute infection were evaluated. The diagnostic performances of the SD BIOLINE NS1 Ag were equivalent to Platelia NS1, 471 patients (14.1%) were NS1 Ag positive with the RDT and 14.2% with Platelia. The Cohen's Kappa coefficient was 0.86 [95%CI: 0.83-0.88], indicating an almost perfect agreement. Moreover, the sensitivity of SD BIOLINE NS1 Ag relative to the RT-PCR method was 87% [95%CI: 80-93%] and the specificity was 92% [95% CI: 87-97%]. However, the SD BIOLINE IgM test was found positive in 6.3% of the samples in comparison to 10.7% with Dx Select IgM. The Cohen's Kappa coefficient was 0.53 [95%CI: 0.47-0.58] indicating a moderate agreement. This raised concern about the SD BIOLINE IgM for the diagnostic of dengue in endemic areas. When considering only NS1 Ag results and not IgM, the RDT could be a viable solution to manage dengue outbreaks in healthcare centers where no laboratory services are available, in the early phase of the disease.