Search Results (32)

Background/Objectives: Digital mammography is widely used for breast cancer screening; however, variations in system design and automatic exposure control (AEC) strategies can lead to significant differences in radiation dose, potentially affecting the diagnostic quality and patient safety. In this study, we aimed to determine the effect of various mammographic technologies on the in vivo mean glandular doses (MGDs) that are received in clinical settings. Methods: The MGDs and applied acquisition parameters from 194,608 mammograms, acquired employing AEC using different digital mammography systems (GE, Siemens, and two different models of Hologic), were retrospectively collected. The potential variation in MGD resulting from different technologies (system and target/filter combination) was assessed employing the Kruskal–Wallis test, followed by Dunn’s post hoc. The AEC optimization of acquisition parameters (kVp, mAs) within each system was investigated through a multi-regression analysis as a function of the compressed breast thickness (CBT). The trend line of these parameters in addition to the MGD and source-to-breast distance were also plotted and compared. Results: There were significant variations in delivered doses per CBT based on which technology was used (p < 0.001). The regression analyses revealed system-specific differences in AEC adjustments of mAs and kVp in response to CBT changes. As the CBT increases, the MGD increases with different degrees, rates, and patterns across systems due to differences in AEC strategies. Conclusions: The MGD is affected by the applied technology, which is different between systems. Clinicians need to be aware of these variations and how they affect the MGD. Additionally, manufacturers may need to consider standardizing the implemented technology effects on the MGDs. Full article

Background: The increasing detection of non-palpable breast lesions necessitates accurate preoperative localization to ensure complete excision while preserving healthy tissue and optimizing cosmetic outcomes. Traditional wire-guided localization (WL) has been the gold standard; however, it has several drawbacks, including patient discomfort and scheduling challenges. This study evaluates the accuracy and feasibility of radiofrequency identification (RFID) tag localization using the Hologic LOCalizer™ system as an alternative technique. Methods: This retrospective study included 258 consecutive patients who underwent image-guided RFID tag localization from March 2021 to February 2023 from a single-center London breast unit. The primary outcome measured was the accuracy of RFID tag placement, defined as within 10 mm of the target lesion on post-clip mammograms. Secondary outcomes included type and size of lesions, re-excision rates, review of post-operative specimen radiographs, and patient demographics. Results: A total of 297 RFID tags were placed, with 95.6% accurately positioned within the target range. The median target size was 29 mm, with the most common abnormalities being mass lesions (64%). Among the 13 inaccurately placed RFID tags (4.4%), all were identified preoperatively, with two requiring additional wire placements. RFID tags were successfully identified in 92% of specimen radiographs, and 8% of patients required re-excision due to positive or close margins. Notably, patients with multiple RFID tags showed a higher incidence of re-excision. Conclusions: The LOCalizer™ RFID system demonstrated a high accuracy rate for preoperative localization of breast lesions, presenting a viable alternative to WL. This technique improves surgical scheduling flexibility and enhances patient comfort. Comparative studies with other wire-free localization technologies, such as magnetic seeds and radar reflectors, are needed to determine the optimal approach for clinical practice. Full article

The aim of this study was to identify single-nucleotide polymorphisms (SNPs) in bone remodeling-related genes associated with disease severity and bone mineral density (BMD) in early arthritis (EA) patients. For this purpose, the genotyping of 552 SNPs located in gene regions of semaphorins 4b, 4d, 4f, DKK1, 2 and 3, sclerostin, OPG, RANK and RANKL was performed using Immunochip from Illumina Inc. in 268 patients from the Princesa Early Arthritis Register Longitudinal (PEARL) study. Measurements of BMD and disease activity were chosen as outcome variables to select SNPs of interest. The relationships of SNPs with the BMD of the forearm, lumbar spine and hip (Hologic-4500 QDR) were analyzed by linear regression adjusted for age, sex, body mass index and presence of anti-citrullinated peptide antibodies (ACPAs). The association of each SNP with activity variables was analyzed by linear regression, logistic regression or ordered logistic regression according to the variable, and multivariate models were adjusted for potentially confounding variables, such as age, sex and presence of ACPAs. These analyses showed that four SNPs located in the genes coding for RANK (TNFRSF11A) and OPG (TNFRSF11B) were significantly associated with clinical variables of severity. SNP rs1805034 located in exon 6 of TNFRSF11A, which causes a non-synonymous (A/V) mutation, showed significant association with BMD and therefore may be considered as a possible biomarker of severity in RA patients. SNPs in the OPG gene showed an association with serum OPG levels and predicted disease activity after two years of follow-up. Full article

This study aimed to evaluate the impact of three two-dimensional (2D) mammographic acquisition techniques on image quality and radiation dose in the presence of silicone breast implants (BIs). Then, we propose and validate a new International Atomic Energy Agency (IAEA) phantom to reproduce these techniques. Images were acquired on a single Hologic Selenia Dimensions^® unit. The mammography of the left breast of a single clinical case was included. Three methods of image acquisition were identified. They were based on misused, recommended, and reference settings. In the clinical case, image criteria scoring and the signal-to-noise ratio on breast tissue (SNR_BT) were determined for two 2D projections and compared between the three techniques. The phantom study first compared the reference and misused settings by varying the AEC sensor position and, second, the recommended settings with a reduced current-time product (mAs) setting that was 13% lower. The signal-difference-to-noise ratio (SDNR) and detectability indexes at 0.1 mm (d’ 0.1 mm) and 0.25 mm (d’ 0.25 mm) were automatically quantified using ATIA software. Average glandular dose (AGD) values were collected for each acquisition. A statistical analysis was performed using Kruskal–Wallis and corrected Dunn tests (p < 0.05). The SNR_BT was 2.6 times lower and the AGD was −18% lower with the reference settings compared to the recommended settings. The SNR_BT values increased by +98% with the misused compared to the recommended settings. The AGD increased by +79% with the misused settings versus the recommended settings. The median values of the reference settings were 5.8 (IQR 5.7–5.9), 1.2 (IQR 0.0), 7.0 (IQR 6.8–7.2) and 1.2 (IQR 0.0) mGy and were significantly lower than those of the misused settings (p < 0.03): 7.9 (IQR 6.1–9.7), 1.6 (IQR 1.3–1.9), 9.2 (IQR 7.5–10.9) and 2.2 (IQR 1.4–3.0) mGy for the SDNR, d’ 0.1 mm, d’ 0.25 mm and the AGD, respectively. A comparison of the recommended and reduced settings showed a reduction of −6.1 ± 0.6% (p = 0.83), −7.7 ± 0.0% (p = 0.18), −6.4 ± 0.6% (p = 0.19) and −13.3 ± 1.1% (p = 0.53) for the SDNR, d’ 0.1 mm, d’ 0.25 mm and the AGD, respectively. This study showed that the IAEA phantom could be used to reproduce the three techniques for acquiring 2D mammography images in the presence of breast implants for raising awareness and for educational purposes. It could also be used to evaluate and optimize the manufacturer’s recommended settings. Full article

Quantification of Torquetenovirus (TTV) viremia is becoming important for evaluating the status of the immune system in solid organ transplant recipients, monitoring the appearance of post-transplant complications, and controlling the efficacy of maintenance immunosuppressive therapy. Thus, diagnostic approaches able to scale up TTV quantification are needed. Here, we report on the development and validation of a real-time PCR assay for TTV quantification on the Hologic Panther Fusion^® System by utilizing its open-access channel. The manual real-time PCR previously developed in our laboratories was optimized to detect TTV DNA on the Hologic Panther Fusion^® System. The assay was validated using clinical samples. The automated TTV assay has a limit of detection of 1.6 log copies per ml of serum. Using 112 samples previously tested via manual real-time PCR, the concordance in TTV detection was 93% between the assays. When the TTV levels were compared, the overall agreement between the methods, as assessed using Passing–Bablok linear regression and Bland–Altman analyses, was excellent. In summary, we validated a highly sensitive and accurate method for the diagnostic use of TTV quantification on a fully automated Hologic Panther Fusion^® System. This will greatly improve the turnaround time for TTV testing and better support the laboratory diagnosis of this new viral biomarker. Full article

Bone Strain Index (BSI), based on dual-energy X-ray absorptiometry (DXA), is a densitometric index of bone strength of the femur and lumbar spine. Higher BSI values indicate a higher strain applied to bone, predisposing to higher fracture risk. This retrospective, multicentric study on Italian women reports the BSI normative age-specific reference curves. A cohort of Caucasian Italian women aged 20 to 90 years was selected from three different clinical centres. Bone mineral density (BMD) and BSI measurements were obtained for the lumbar spine vertebrae (L1–L4) and for the femur (neck, trochanter and intertrochanter) using Hologic densitometers scans. The data were compared with BMD normative values provided by the densitometer manufacturer. Then, the age-specific BSI curve for the femur and lumbar spine was generated. No significant difference was found between the BMD of the subjects in this study and BMD reference data provided by Hologic (p = 0.68 for femur and p = 0.90 for lumbar spine). Spine BSI values (L1–L4) increase by 84% between 20 and 90 years of age. The mean BSI of the total femur increases about 38% in the same age range. The BSI age-specific reference curve could help clinicians improve osteoporosis patient management, allowing an appropriate patient classification according to the bone resistance to the applied loads and fragility fracture risk assessment. Full article

Candida auris, a resilient pathogenic yeast with frequent multidrug resistance, presents a persistent challenge in healthcare settings. The timely identification of C. auris is crucial for infection control and prevention, especially in facilities facing unique hurdles, such as our institution, which serves four major hospitals and approximately 80% of the Texas inmate population. Understaffing, communal living, and financial constraints exacerbate infection control issues. To address common staff shortages, streamline testing services, and enhance testing efficiency, there was a pressing need for rapid and high-throughput detection of C. auris. This study presents the validation and utility of an assay implemented on the Hologic Fusion Open Access platform using samples collected from high-risk patients’ axilla and groin areas, as well as environmental swab samples from patient rooms. Our assay complemented efforts to control C. auris outbreaks within our healthcare system, providing valuable insights into its presence within surveillance samples. This assay demonstrated the value of high-throughput molecular detection platforms in challenging healthcare environments by aiding infection preventionists in containing the spread of C. auris and preventing nosocomial infections. Our research contributes essential data on the suitability and performance of the Hologic Fusion Open Access platform for C. auris detection. These findings hold significant implications for enhancing surveillance and control measures in high-risk settings, making a significant impact on the field of infection control and prevention. Full article

Breast conservative surgery is the primary therapeutic choice for non-aggressive early breast cancers, and a minimally-invasive approach is strongly recommended. The breast localization represents a modern challenge for surgery. Wire-guided localization is still the gold standard technique, but new wireless systems have been proposed, such as radiofrequency identification with LOCalizer^TM (Hologic, Santa Carla, CA, USA), which reports encouraging results. The current study aimed to evaluate the accuracy and efficacy of the combined use of LOCalizer^TM and ultrasound compared with the results obtained using LOCalizer^TM alone for the detection of non-palpable breast cancer. Ninety-six patients who were candidates for breast localization were enrolled. Group A received a combined localization with LOCalizer^TM and US, while group B underwent only LOCalizer^TM identification. Oncological radicality was reached in 100% of the patients in Group A and in 89.2% of the patients in Group B, with p = 0.006. The mean specimens’ volume was 13.2 ± 0.6 cm³ for Group A and 16.1 ± 1.4 cm³ for Group B, while mean specimen weights were 21.8 ± 2.2 and 24.4 ± 1.8 g, respectively (p = 0.003 and p = 0.004, respectively). LOCalizer^TM with ultrasound, in the current series, has resulted in the preferred option for the localization of non-palpable breast cancer, allowing limited resection (in weight and volume), guaranteeing excellent oncological outcomes, and great satisfaction for patients and physicians. Full article

The estimation of viscosity by measuring the shear-wave dispersion (SWD) using ultrasound 2D shear-wave elastography (SWE) is becoming more and more popular. Recent research suggests that SWD can be used in addition to 2D-SWE (shear-wave speed) to diagnose diffuse liver disease. Viscosity was studied for the assessment of normal thyroid tissue. This study aims to evaluate the use of viscosity measurements in patients with chronic autoimmune thyroiditis using the SuperSonic MACH^®30 ultrasound machine (Hologic SuperSonic Imagine, Aix-en-Provence, France) which provides the Vi PLUS mode for viscosity and the 2D SWE PLUS mode for shear-wave speed measurements. Valid measurements were obtained in 308 cases, 153 with chronic autoimmune thyroiditis (CAT) and 155 with no thyroid pathology (95.95% feasibility of the methods). The differences between the healthy group and the CAT group were statistically significant both for Vi PLUS (2.5 ± 0.4 vs. 2.8 ± 0.5, p < 0.0001) and for 2D-SWE PLUS (13.5 ± 3.3 vs. 23.1 ± 8.3, p < 0.0001). The diagnostic performance was poor for Vi PLUS alone (AUC = 0.69; cut-off > 2.5 Pa·s, se = 68.6%; sp = 64.52%) and good for 2D-SWE PLUS alone (AUC = 0.861; cut-off > 18.4 kPa, se = 69.9%; sp = 92.2%). Vi PLUS correlated with 2D-SWE PLUS, with the presence of CAT, the thyroid volume, levothyroxine replacement therapy and age. Statistically significant differences were found between the CAT subgroup receiving thyroid replacement therapy and the subgroup without therapy: 24.74 ± 8.33 vs. 21.93 ± 8.12 kPa for 2D-SWE (p = 0.0380) and 3 ± 0.5 vs. 2.7 ± 0.4 Pa·s for Vi PLUS (p = 0.0193). Elastography-based methods improve the classic ultrasound evaluation: 2D-SWE PLUS performed somewhat better in distinguishing CAT from normal thyroid tissue, while Vi PLUS made a slightly better assessment regarding the functional status. Full article

Introduction: A renal biopsy represents the gold standard in the diagnosis, prognosis, and management of patients with glomerulonephritis. So far, non-invasive elastographic techniques have not confirmed their utility in replacing a biopsy; however, the new and improved software from Hologic Supersonic Mach 30 is a promising method for assessing the renal tissue’s stiffness and viscosity. We investigated whether this elastography technique could reveal renal tissue fibrosis in patients with chronic glomerulonephritis. Materials and methods: Two-dimensional-shear wave elastography (SWE) PLUS and viscosity plane-wave ultrasound (Vi PLUS) assessments were performed in 40 patients with chronic glomerulopathies before being referred for a renal biopsy. For each kidney, the mean values of five stiffness and viscosity measures were compared with the demographic, biological, and histopathological parameters of the patients. Results: In total, 26 men and 14 women with a mean age of 52.35 ± 15.54 years, a mean estimated glomerular filtration rate (eGFR) of 53.8 ± 35.49 mL/min/1.73m², and a mean proteinuria of 6.39 ± 7.42 g/24 h were included after providing their informed consent. Out of 40 kidney biopsies, 2 were uninterpretable with inappropriate material and were divided into four subgroups based on their fibrosis percentage. Even though these elastography techniques were unable to differentiate between separate fibrosis stages, when predicting between the fibrosis and no-fibrosis group, we found a cut-off value of <20.77 kPa with the area under the curve (AUC) of 0.860, a p < 0.001 with 88.89% sensitivity, and a 75% specificity for the 2D SWE PLUS measures and a cut-off value of <2.8 Pa.s with an AUC of 0.792, a p < 0.001 with 94% sensitivity, and a 60% specificity for the Vi PLUS measures. We also found a cut-off value of <19.75 kPa for the 2D SWE PLUS measures (with an AUC of 0.789, p = 0.0001 with 100% sensitivity, and a 74.29% specificity) and a cut-off value of <1.28 Pa.s for the Vi PLUS measures (with an AUC 0.829, p = 0.0019 with 60% sensitivity, and a 94.29% specificity) differentiating between patients with over 40% fibrosis and those with under 40%. We also discovered a positive correlation between the glomerular filtration rate (eGFR) and 2D-SWE PLUS values (r = 0.7065, p < 0.0001) and Vi PLUS values (r = 0.3637, p < 0.0211). C reactive protein (CRP) correlates with the Vi PLUS measures (r = −0.3695, p = 0.0189) but not with the 2D SWE PLUS measures (r = −0.2431, p = 0.1306). Conclusion: Our findings indicate that this novel elastography method can distinguish between individuals with different stages of renal fibrosis, correlate with the renal function and inflammation, and are easy to use and reproducible, but further research is needed for them to be employed routinely in clinical practice. Full article

Background: Oropharyngeal (OP) and nasopharyngeal (NP) sampling has historically been considered the reference specimen type used for respiratory virus detection. Saliva could be a less invasive alternative for SARS-CoV-2 detection, but limited evidence is available. Methods: The technical and clinical performance of saliva was compared to OP/NP on the Hologic Panther platform with two Aptima assays, the End-Point Transcription-Mediated Amplification assay (EP-TMA) and Real-Time Transcription-Mediated Amplification assay (RT-TMA). The samples were collected at the Public Health Service Testing Site XL location in Schiphol Amsterdam Airport. At the site, the Regional Public Health Laboratory Kennemerland (RPHLK) has a fully equipped laboratory facility. Results: A total of 374 samples (187 OP/NP swabs and 187 saliva samples) were collected from 187 unique patients. The Real-Time Transcription-Mediated Amplification assay (RT-TMA) resulted in comparable sensitivities for the detection of SARS-CoV-2 in both the OP/NP swabs (88.3%; 113/128) and saliva samples (87.5%; 112/128). The End-Point Transcription-Mediated Amplification assay (EP-TMA) analyses showed a similar sensitivity (86.7%; 111/128) in the OP/NP swabs but a lower sensitivity in the saliva samples (80.5%; 103/128). Within the discordant analyses, we found no associations in the symptoms, earlier SARS-CoV-2 infections and eating, smoking, drinking and tooth brushing habits within one hour before testing. Conclusions: The Hologic Panther platform Real-Time Transcription-Mediated Amplification assay (RT-TMA) yields a sensitivity for the detection of SARS-CoV-2 in saliva that is comparable to the OP/NP swabs derived from participants presenting themselves at a public health testing facility with minimal or mild symptoms. Full article

Karate is a widely practiced combat sport. Karatekas’ body composition has typically been obtained in small groups using skinfolds or bioelectric impedance. In this work, we assessed three-compartment body composition using the accurate dual-energy X-ray absorptiometry technique (QDR Horizon, Hologic) in a large sample (n = 58; 74% males) of black belt karatekas. Stature-adjusted body composition indices (fat mass index; fat-free mass index; bone mineral apparent density) were calculated. The Student’s t-test was used for group–group analysis. Correlation was assessed using the Pearson’s r. The ability of fat-free soft tissue mass to predict bone mineral content and areal bone mineral density was assessed with linear regression. Reference mean and quartile values for whole-body and regional body composition were obtained for the male athletes. The body composition indices were generally more favorable in the male than female karatekas. The bone mineral apparent density was similar in the males and females at all sites except the right leg. The fat-free soft tissue mass predicted the bone mineral content and areal bone mineral density with good accuracy (R² = 0.542–0.827; p < 0.001 for all models). The data presented in this paper are expected to be of use for karate coaches, physical trainers, and participants interested in assessing and monitoring athletes’ body composition. Full article

Introduction: There is currently a lack of published data on kidney elasticity and viscosity. Non-invasive techniques, such as two-dimensional shear-wave elastography (2D-SWE PLUS) and viscosity plane-wave ultrasound (Vi PLUS), have surfaced as new detection methods, which, thanks to efficient processing software, are expected to improve renal stiffness and viscosity measurements. This study aims to be the first one to assess the normal range values in normal renal function subjects and to investigate the factors that impact them. Methods: We conducted a cross-sectional study employing 50 participants (29 women and 21 men) with a mean age of 42.22 ± 13.17, a mean estimated glomerular filtration rate (eGFR) of 97.12 ± 11 mL/min/1.73 m², a mean kidney length of 10.16 ± 0.66 cm, and a mean body mass index (BMI) of 24.24 ± 3.98. With a C6-1X convex transducer and the Ultra-FastTM software available on the Hologic Aixplorer Mach 30 ultrasound system, we acquired five measurements of renal cortical stiffness and viscosity (achieved from five distinct images in the middle part of the subcapsular cortex) from each kidney. The ten measurements’ median values correlated with the participant’s demographical, biological, and clinical parameters. Results: The mean kidney elasticity was 31.88 ± 2.89 kiloPascal (kPa), and the mean viscosity was 2.44 ± 0.57 Pascal.second (Pa.s) for a mean measurement depth 4.58 ± 1.02 cm. Renal stiffness seemed to be influenced by age (r = −0.7047, p < 0.0001), the measurement depth (r = −0.3776, p = 0.0075), and eGFR (r = 0.6101, p < 0.0001) but not by BMI (r = −0.2150, p = 0.1338), while viscosity appeared to be impacted by age (r = −0.4251, p = 0.0021), eGFR (r = 0.4057, p = 0.0038), the measurement depth (r = −0.4642, p = 0.0008), and BMI (r = −0.3676, p = 0.0086). The results of the one-way ANOVA used to test the differences in the variables among the three age sub-groups are statistically significant for both 2D-SWE PLUS (p < 0.001) and Vi PLUS (p = 0.015). The method found good intra-operator reproducibility for the 2D-SWE PLUS measurements, with an ICC of 0.8365 and a 95% CI of 0.7512 to 0.8990, and for the Vi PLUS measurements, with an ICC of 0.9 and a 95% CI of 0.8515 to 0.9397. Conclusions: Renal stiffness and viscosity screening may become an efficacious, low-cost way to gather supplemental diagnostic data from patients with chronic kidney disease (CKD). The findings demonstrate that these non-invasive methods are highly feasible and not influenced by gender and that their values correlate with renal function and decrease with age progression. Nevertheless, more research is required to ascertain their place in clinical practice. Full article

The most widely used method in professional sports for fat percentage assessment is the skinfold method. However, there is the chance of bias and human error. For this reason, other more precise methods are used, such as single-frequency bioelectrical impedance analysis (BIA) or dual energy X-ray absorptiometry (DEXA). However, there are limited data that demonstrate the methodological shortcomings or congruences in fat and fat-free mass estimates including gender differences and differences in athlete populations. Thus, the aim of the present study was to compare total body fat (%BF) estimated by six skinfold thickness measurement (SKF) and single-frequency bioelectrical impedance analysis (BIA) methods, using three different sets of equations, to that assessed by the dual energy X-ray absorptiometry (DEXA) method using a DEXA Hologic Serie Discovery QDR. For this aim, 76 males and 70 females belonging to the professional Spanish football federation were evaluated. We found significant differences between the three measures. BIA significantly underestimates the fat percentage, followed by skinfolds. With DEXA being the more objective or accurate method, an equation is established by means of linear regression analysis that allows the percentage of adipose tissue to be obtained either through anthropometry or electrical bioimpedance and adjusted to that which would be obtained by the DEXA system. Full article

Rapid diagnosis is key to containing viral outbreaks. However, for the current monkeypox outbreak the major deterrent to rapid testing is the requirement for higher biocontainment of potentially infectious monkeypox virus specimens. The current CDC guidelines require the DNA extraction process before PCR amplification to be performed under biosafety level 3 unless vaccinated personnel are performing assays. This increases the turn-around time and makes certain laboratories insufficiently equipped to handle specimens from patients with suspected monkeypox infection. We investigated the ability of five commercially available lysis buffers and heat for inactivation of monkeypox virus. We also optimized the use of monkeypox virus in Hologic^® Panther Specimen Lysis Buffer for detection of virus in the Panther Fusion^® Open Access System using published generic and clade specific monkeypox virus primers and probes. Full article