Bengul Durmaz, Tuba Dal, Hande Toptan, Mehmet Koroglu, Rıza Durmaz
{"title":"Analytical and clinical performance of a novel DiaRD CMV qPCR assay for cytomegalovirus DNA quantification: a comparative study with the artus CMV RG PCR kit.","authors":"Bengul Durmaz, Tuba Dal, Hande Toptan, Mehmet Koroglu, Rıza Durmaz","doi":"10.1080/14737159.2026.2721430","DOIUrl":"10.1080/14737159.2026.2721430","url":null,"abstract":"<p><strong>Background: </strong>Cytomegalovirus (CMV) remains a major cause of morbidity in transplant recipients and patients with hematological malignancies, requiring accurate viral load monitoring for clinical management. This study evaluated the performance of the novel DiaRD CMV qPCR assay compared with the reference artus CMV RG PCR Kit.</p><p><strong>Research design and methods: </strong>A total of 180 anonymized plasma samples, including 47 CMV-positive and 133 CMV-negative specimens, were retrospectively analyzed. Diagnostic accuracy, quantitative agreement, analytical specificity, and precision were assessed.</p><p><strong>Results: </strong>The DiaRD assay correctly identified 45 of 47 positive samples, yielding a sensitivity of 95.7% and specificity of 96.2%, with an overall accuracy of 96.1%. Positive and negative predictive values were 90.0% and 98.5%, respectively. Quantitative analysis demonstrated strong correlation between assays (R<sup>2</sup> = 0.880, <i>r</i> = 0.938, <i>p</i> < 0.0001). Bland-Altman analysis showed good agreement, with a mean difference of -0.009 log<sub>10</sub> IU/mL (SD: 0.272). Among concordant positive samples, 40 showed differences of <0.5 log<sub>10</sub> IU/mL. No cross-reactivity was detected with other tested pathogens. Precision studies demonstrated coefficients of variation below 2% for Ct values and ≤6.81% for viral loads.</p><p><strong>Conclusion: </strong>Overall, the DiaRD CMV qPCR assay demonstrated reliable analytical and diagnostic performance, supporting its suitability for routine CMV DNA quantification in clinical laboratories.</p>","PeriodicalId":12113,"journal":{"name":"Expert Review of Molecular Diagnostics","volume":" ","pages":"851-861"},"PeriodicalIF":4.3,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148790072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aleksandra Wiśniewska, Paweł Sobczuk, Piotr Rutkowski
{"title":"Molecular events underlying sarcoma development and progression: the diagnostic relevance.","authors":"Aleksandra Wiśniewska, Paweł Sobczuk, Piotr Rutkowski","doi":"10.1080/14737159.2026.2733191","DOIUrl":"10.1080/14737159.2026.2733191","url":null,"abstract":"<p><strong>Introduction: </strong>Sarcomas are a very rare (<1% solid tumors) and highly heterogeneous group of malignant neoplasms with over 100 subtypes. The complexity and rarity of this disease pose serious troubles with differential diagnosis with the use of traditional methods (histology and immunohistochemistry); hence, there is more and more interest in the genetic background of sarcoma development and prognosis in search for genetic markers that might allow the improvement of the diagnostic process, disease prognosis, and monitoring.</p><p><strong>Areas covered: </strong>This review provides a brief summary of current knowledge of the diagnostic relevance of the molecular background of sarcoma. It includes descriptions of traditional and novel methods for genetic alteration assessments, as well as perspectives on the diagnostic or prognostic use of certain genetic markers.</p><p><strong>Expert opinion: </strong>The origin of most sarcomas remains not fully understood, even with rapid advances in high-precision molecular techniques. There is an ongoing need for further studies aimed to uncover the complete mechanisms behind the development and progression of these rare yet dangerous tumors, especially in light of improved differential diagnosis and targeted treatment options, including early phase clinical trials.</p>","PeriodicalId":12113,"journal":{"name":"Expert Review of Molecular Diagnostics","volume":" ","pages":"829-850"},"PeriodicalIF":4.3,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Qamar Abuhassan, Husni Farah, M M Rekha, Aniruddh Dash, M Bavanilatha, Gurjant Singh, Aashna Sinha, Ravshan Sultanov
{"title":"Nanotheranostics in orthopedic diseases: a critical review of molecular diagnostic-driven targeted therapeutics for personalized patient care.","authors":"Qamar Abuhassan, Husni Farah, M M Rekha, Aniruddh Dash, M Bavanilatha, Gurjant Singh, Aashna Sinha, Ravshan Sultanov","doi":"10.1080/14737159.2026.2733189","DOIUrl":"10.1080/14737159.2026.2733189","url":null,"abstract":"<p><strong>Introduction: </strong>Orthopedics could greatly benefit from nanotechnology, especially in drug delivery, bone tissue engineering, and implant design. Nanotheranostics represents a major step toward individualized treatment by combining diagnosis and treatment into a single nanoplatform. For orthopedic applications, nanocarriers such as carbon nanotubes, dendrimers, liposomes, and metallic or polymeric nanoparticles offer distinct advantages. Significant clinical challenges still exist, such as unresolved long-term toxicity, lack of knowledge about nanoparticle-bone interactions, manufacturing scale-up challenges, and regulatory barriers.</p><p><strong>Areas covered: </strong>This review covers: (1) theranostic nanoparticles (iron oxide, gold, quantum dots, lipid-based systems); (2) therapeutic applications in osteoarthritis, rheumatoid arthritis, osteoporosis, and bone infections; (3) imaging and biomarker detection; (4) safety considerations including cytotoxicity, immunogenicity, and biocompatibility; and (5) personalized medicine advancements. Preclinical data suggest real-time therapy monitoring, tailored administration, and integrated diagnostics.</p><p><strong>Expert opinion: </strong>Despite encouraging evidence, clinical translation faces constraints including chronic toxicity concerns, inaccurate animal models, high costs, and lacking regulatory frameworks. Future progress requires biocompatible materials with predictable pharmacokinetics, standardized safety procedures, and large animal model validation. Rather than complex multipurpose systems, straightforward platforms targeting specific high-value needs will yield the greatest advances. Nanotheranostics offers a revolutionary path toward customized, minimally invasive orthopedic therapy, improving patient outcomes through interdisciplinary cooperation.</p>","PeriodicalId":12113,"journal":{"name":"Expert Review of Molecular Diagnostics","volume":" ","pages":"1-29"},"PeriodicalIF":4.3,"publicationDate":"2026-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Culture-free genomics: a shift toward genome-wide applications in Chagas disease and leishmaniasis.","authors":"Juan C Hernandez-Valencia, Juan David Ramírez","doi":"10.1080/14737159.2026.2733187","DOIUrl":"10.1080/14737159.2026.2733187","url":null,"abstract":"<p><strong>Introduction: </strong>Chagas disease and leishmaniasis remain major neglected tropical diseases, with diagnosis and surveillance constrained by low parasite burden, multiclonal infections, and complex parasite biology. Traditional culture-dependent and targeted molecular approaches fail to capture the full genomic diversity of <i>Trypanosoma cruzi</i> and <i>Leishmania</i> spp. limiting clinical and epidemiological utility.</p><p><strong>Areas covered: </strong>We review the evolution from early sequencing to second- and third-generation platforms, highlighting culture-free detection and genomic surveillance. We discuss enrichment strategies (selective whole-genome amplification (SWGA) and capture-enrichment sequencing (CES)) addressing low parasite DNA abundance in complex samples, alongside metagenomics and portable sequencing for field-based surveillance and diagnostics. We further explore how direct-from-host data can improve diagnostics, enhance transmission surveillance, support treatment monitoring, and guide control strategies.</p><p><strong>Expert opinion: </strong>Culture-free genomic approaches represent a transformative advance in kinetoplastid research, providing resolution that culture-dependent methods cannot deliver. Their diagnostic contribution is at present largely indirect, operating through the identification of improved molecular and serological targets rather than through sequencing as the assay itself. Persistent barriers of cost, infrastructure, standardization, and bioinformatics capacity, together with the absence of formal clinical validation, currently confine these methods to research and surveillance settings.</p>","PeriodicalId":12113,"journal":{"name":"Expert Review of Molecular Diagnostics","volume":" ","pages":"1-15"},"PeriodicalIF":4.3,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148944570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Innovations in the diagnosis of <i>Pythium insidiosum</i> keratitis: molecular advances and the path to point-of-care testing.","authors":"Bharat Gurnani, Kirandeep Kaur","doi":"10.1080/14737159.2026.2733166","DOIUrl":"10.1080/14737159.2026.2733166","url":null,"abstract":"<p><strong>Introduction: </strong><i>Pythium insidiosum</i> keratitis is an aggressive, vision-threatening corneal infection that closely mimics fungal keratitis clinically and on smear microscopy, frequently delaying targeted therapy and appropriate surgical intervention. Rapid and reliable molecular diagnosis is therefore critical, particularly given the small-volume, low-biomass nature of corneal specimens encountered in routine ophthalmic practice worldwide, especially in endemic regions with limited diagnostic infrastructure.</p><p><strong>Areas covered: </strong>This review summarizes advances in molecular diagnostics for <i>Pythium insidiosum</i> keratitis, including conventional and nested PCR, duplex and multiplex PCR, real-time PCR, high-resolution melt analysis, loop-mediated isothermal amplification (LAMP), colorimetric LAMP, metagenomic sequencing, and CRISPR-based platforms. Key diagnostic targets such as ITS, 18S rRNA, COX2, and PinsEXO1 are evaluated for analytical sensitivity, specificity, turnaround time, contamination control, and applicability in endemic, resource-limited settings and peripheral ophthalmic centers with limited infrastructure and limited availability of trained personnel.</p><p><strong>Expert opinion: </strong>Future progress will depend on integrating robust molecular targets with closed-tube, contamination-resistant amplification platforms within tiered diagnostic systems. Colorimetric LAMP offers immediate translational potential, while PinsEXO1-based assays enhance specificity. CRISPR-based detection and microfluidic integration remain promising but require rigorous validation in ocular specimens before routine clinical adoption in diverse real-world settings globally, across varied healthcare systems and populations.</p>","PeriodicalId":12113,"journal":{"name":"Expert Review of Molecular Diagnostics","volume":" ","pages":"1-23"},"PeriodicalIF":4.3,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148944574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Luis Adrián De Jesús-González, Flor Itzel Lira-Hernández, Alan Orlando Santos-Mena, Juan Carlos Borrego-Moreno
{"title":"Respiratory viral co-detection in the multiplex era: a critical perspective on diagnostic stewardship and anti-infective decision-making.","authors":"Luis Adrián De Jesús-González, Flor Itzel Lira-Hernández, Alan Orlando Santos-Mena, Juan Carlos Borrego-Moreno","doi":"10.1080/14737159.2026.2726945","DOIUrl":"https://doi.org/10.1080/14737159.2026.2726945","url":null,"abstract":"<p><strong>Introduction: </strong>Respiratory viral co-detection has become increasingly frequent with the widespread use of multiplex molecular panels. However, detecting two or more respiratory viruses in a single sample does not necessarily indicate active coinfection, etiologic equivalence, or the need to escalate antiviral or antibacterial therapy.</p><p><strong>Areas covered: </strong>This critical perspective examines respiratory viral co-detection as a diagnostic stewardship and anti-infective decision-making challenge. It proposes an interpretive framework that distinguishes molecular co-detection from probable coinfection, sequential infection, prolonged nucleic acid shedding, and clinically actionable co-detection. The article discusses how symptom timing, syndromic compatibility, local viral circulation, host vulnerability, and therapeutic availability should guide interpretation. It also addresses the limitations of Ct values as surrogate markers of viral burden, the potential contribution of host-response biomarkers, the influence of vaccination and immunoprophylaxis, and the implications of viral interactions for clinical reasoning and antiviral trial design.</p><p><strong>Expert opinion: </strong>Multiplex panels provide the greatest value when interpreted as tools for therapeutic prioritization, antibacterial stewardship, infection control, and risk stratification rather than as flat lists of equivalent etiologies. Future antiviral studies should incorporate co-detection as a prespecified modifier of clinical and treatment outcomes.</p>","PeriodicalId":12113,"journal":{"name":"Expert Review of Molecular Diagnostics","volume":" ","pages":"1-17"},"PeriodicalIF":4.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148873054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Carlos Martínez-Pérez, Giovanni Tramonti, Charlene Kay, Karen J Taylor, Alastair Ironside, Arran K Turnbull, Peter S Hall
{"title":"The 21-gene recurrence score assay as a tool for predicting recurrence risk and guiding adjuvant treatment selection in early breast cancer.","authors":"Carlos Martínez-Pérez, Giovanni Tramonti, Charlene Kay, Karen J Taylor, Alastair Ironside, Arran K Turnbull, Peter S Hall","doi":"10.1080/14737159.2026.2709442","DOIUrl":"10.1080/14737159.2026.2709442","url":null,"abstract":"<p><strong>Introduction: </strong>Estrogen receptor-positive (ER+), HER2-negative breast cancer is the most common breast cancer subtype. While adjuvant endocrine therapy reduces recurrence risk, identifying which patients benefit from the addition of chemotherapy remains a key clinical challenge. The Oncotype DX® 21-gene Recurrence Score assay (Exact Sciences, via Genomic Health, Inc.) was developed to address this by quantifying distant recurrence risk and informing chemotherapy decisions in early-stage ER+/HER2- disease.</p><p><strong>Areas covered: </strong>This diagnostic profile reviews the development, validation, and clinical evidence for Oncotype DX, including findings from the TAILORx and RxPONDER prospective trials and the subsequent development of hybrid tools integrating genomic and clinicopathological data. Alternative multiparameter molecular tests (MammaPrint, Prosigna, EndoPredict, Breast Cancer Index) are summarized and compared. We review international guideline recommendations, decision impact studies, cost-effectiveness evidence, and ongoing trials.</p><p><strong>Expert opinion: </strong>Oncotype DX has strong prognostic evidence and has meaningfully reduced chemotherapy use, though its case as a biomarker predictive of therapeutic effect from chemotherapy rests on trial designs with important limitations. Its independent prognostic contribution beyond comprehensive clinicopathological assessment requires further clarification, and cost-effectiveness varies substantially by indication and healthcare setting.</p>","PeriodicalId":12113,"journal":{"name":"Expert Review of Molecular Diagnostics","volume":" ","pages":"723-732"},"PeriodicalIF":4.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148673121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kelechi Njoku, Molly Dore, Jean-Ellen Johnson, Jennifer C Davies, Andrew Pierce, Davide Chiasserini, Ananya Choudhury, Anthony D Whetton, Richard Unwin, Emma J Davidson
{"title":"Protein signatures for the early detection of endometrial cancer in cervico-vaginal fluid.","authors":"Kelechi Njoku, Molly Dore, Jean-Ellen Johnson, Jennifer C Davies, Andrew Pierce, Davide Chiasserini, Ananya Choudhury, Anthony D Whetton, Richard Unwin, Emma J Davidson","doi":"10.1080/14737159.2026.2705465","DOIUrl":"10.1080/14737159.2026.2705465","url":null,"abstract":"<p><strong>Introduction: </strong>Endometrial cancer is the most common gynecological malignancy in high-income countries. Although postmenopausal bleeding is its cardinal presenting symptom, only 5-10% of women with postmenopausal bleeding have malignancy. There is therefore a need for accurate, minimally invasive diagnostic tests. Proteins detectable in proximal biofluids, particularly cervicovaginal fluid (CVF), represent promising biomarkers because they reflect the functional biology of the tumor and can be measured using clinically translatable immunoassays.</p><p><strong>Areas covered: </strong>This review critically evaluates the evidence for CVF protein biomarkers in the early detection of endometrial cancer. Three protein signatures show the greatest promise: a five-protein panel (HPT, LGALS3BP, FGA, LY6D, IGHM; AUC 0.95), a 12-protein inflammatory panel (AUC 0.91), and an 11-protein multivariate panel (AUC 0.92), all approaching or meeting thresholds for clinical consideration. We also discuss the biological relevance of these proteins and highlight the methodological, analytical and translational challenges that must be addressed before clinical implementation.</p><p><strong>Expert opinion: </strong>CVF provides a unique, minimally invasive sampling medium owing to the anatomical continuity between the uterine cavity and lower genital tract. While current evidence is encouraging, most candidate biomarkers remain exploratory and require rigorous validation in large, prospective multicentre studies before incorporation into routine clinical practice.</p>","PeriodicalId":12113,"journal":{"name":"Expert Review of Molecular Diagnostics","volume":" ","pages":"739-753"},"PeriodicalIF":4.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148469752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The association between normalized creatinine-to-cystatin C ratio and incident circadian syndrome in middle-aged and older adults: a national cohort study.","authors":"Zhengyi Xia, Minghui Li, Ling Li","doi":"10.1080/14737159.2026.2705464","DOIUrl":"10.1080/14737159.2026.2705464","url":null,"abstract":"<p><strong>Background: </strong>Evidence on the association between the normalized creatinine-to-cystatin C ratio (NCCR) and Circadian Syndrome (CircS) in the general population remains scarce. This study aimed to investigate this relationship using data from middle-aged and elderly participants in the China Health and Retirement Longitudinal Study (CHARLS).</p><p><strong>Methods: </strong>We conducted a cross-sectional analysis of 5,981 participants (2011 wave) and a prospective cohort analysis of 2,053 participants (2015 wave, median follow-up 4.0 years). CircS was defined as a cluster including elevated blood pressure, dyslipidemia, hyperglycemia, abdominal obesity, depression, and abnormal sleep duration.</p><p><strong>Results: </strong>During follow-up, 552 participants developed incident CircS. A significant inverse association was observed: the risk of new-onset CircS progressively decreased with higher baseline NCCR levels. After adjusting for multiple confounders, each standard deviation increase in NCCR was associated with a 40% reduced odds of CircS (adjusted odds ratio = 0.60, 95% confidence interval: 0.48 to 0.75). Subgroup and dose-response analyses confirmed the robustness of this inverse relationship.</p><p><strong>Conclusions: </strong>In conclusion, a lower NCCR is independently associated with an elevated risk of developing CircS. These findings support NCCR's role as a practical serum indicator of sarcopenia and implicate muscle loss as a potentially key underlying pathway in the pathogenesis of Circadian Syndrome.</p>","PeriodicalId":12113,"journal":{"name":"Expert Review of Molecular Diagnostics","volume":" ","pages":"775-782"},"PeriodicalIF":4.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148455210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}