NanotheranosticsPub Date : 2025-03-03eCollection Date: 2025-01-01DOI: 10.7150/ntno.105433
Jae-Yong Lee, Jaehyoung Kim, Kyuheum Na, Hee-Jin Ahn
{"title":"GMP manufacturing of umbilical cord blood mesenchymal stem cell-released exosomes and verification of wound healing efficacy.","authors":"Jae-Yong Lee, Jaehyoung Kim, Kyuheum Na, Hee-Jin Ahn","doi":"10.7150/ntno.105433","DOIUrl":"10.7150/ntno.105433","url":null,"abstract":"<p><p><b>Rationale:</b> Drug development research using exosomes is being actively conducted worldwide. However, clear management standards and verification systems for the use of exosomes as drugs are still being developed. In this study, the effectiveness of exosomes as drug candidates was verified after production in accordance with the guidelines for donor suitability, cell bank construction of cell therapy drugs, and quality control of extracellular vesicles published by the Korean Ministry of Food and Drug Safety (KMFDS). <b>Methods:</b> Basic characteristics were identified using umbilical cord blood mesenchymal stem cells (UCBMSCs)-released exosomes produced in accordance with the three guidelines, and internal component analysis of proteins, lipids, and nucleic acids was performed. In addition, various types of <i>in vitro</i> and <i>in vivo</i> experiments confirmed the skin tissue regeneration efficacy of exosomes. <b>Results:</b> In addition, treatment of two types of skin cells (dermal fibroblast and keratinocyte) with exosomes resulted in a statistically significant increase in the proliferation and migration of skin cells and inhibition of the secretion of pro-inflammatory substances in an inflammatory environment. In an animal model of wound injury, exosome treatment accelerated the wound healing process. These <i>in vitro</i> and <i>in vivo</i> experiments confirm that UCBMSCs-released exosomes have tissue regeneration and inflammation suppression properties. <b>Conclusions:</b> This study presents the processes and quality control items that can produce exosomes as drugs in good manufacturing practice facilities and shows the possibility of developing drugs for various diseases based on the inherent efficacy of UCBMSCs-released exosomes. This study is the first to show how exosomes can be produced and quality-validated in a GMP facility for use as drugs, which will accelerate the time to market for future exosomes base bio-new drug.</p>","PeriodicalId":36934,"journal":{"name":"Nanotheranostics","volume":"9 2","pages":"95-109"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11980038/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144051763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NanotheranosticsPub Date : 2025-03-03eCollection Date: 2025-01-01DOI: 10.7150/ntno.98946
Almina I Polinova, Anna V Serkina, Marina V Volkova, Aleksandr A Gorbunov, Evgeniia P Sannikova, Irek I Gubaidullin, Aleksandr S Komolov, Anna V Rybakova, Marina Yu Kopaeva, Konstantin S Plokhikh, Georgy S Peters, Artem A Shatilov, Alexander A Shtil, Galina A Posypanova, Alexander P Trashkov, Natalia V Bulushova, Dmitry G Kozlov
{"title":"A miniature low-immunogenic platform for the biosynthesis of self-assembling protein nanoparticles.","authors":"Almina I Polinova, Anna V Serkina, Marina V Volkova, Aleksandr A Gorbunov, Evgeniia P Sannikova, Irek I Gubaidullin, Aleksandr S Komolov, Anna V Rybakova, Marina Yu Kopaeva, Konstantin S Plokhikh, Georgy S Peters, Artem A Shatilov, Alexander A Shtil, Galina A Posypanova, Alexander P Trashkov, Natalia V Bulushova, Dmitry G Kozlov","doi":"10.7150/ntno.98946","DOIUrl":"10.7150/ntno.98946","url":null,"abstract":"<p><p><b>Aims:</b> Previously, to obtain antigen-presenting self-assembling protein nanoparticles (SAPN), we developed a biosynthetic platform combining the self-associating peptide L<sub>6</sub>KD and the SUMO protein. In the current work, the immunogenic SUMO was replaced with an artificial 30 amino acid long peptide pepA1. <b>Methods:</b> The immunogenic properties of the pepA1-SAPN were tested in mice using the pneumococcal PhtD19 and ovalbumin OVA<sub>257-280</sub> antigens in the absence of adjuvants. <b>Results and Conclusions:</b> The updated SAPN showed a 100% seroconversion rate and low immunogenicity of the platform. Given the effective synthesis and improved purification procedure, the pepA1-based miniature platform looks promising for development of vaccines and vehicles for targeted delivery.</p>","PeriodicalId":36934,"journal":{"name":"Nanotheranostics","volume":"9 1","pages":"67-81"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11898719/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NanotheranosticsPub Date : 2025-03-03eCollection Date: 2025-01-01DOI: 10.7150/ntno.101699
Ahmad Kurniawan, Isa Mahendra, Asep Rizaludin, Marhendra Satria Utama, Ronny Lesmana, Fitria Dwi Ayuningtyas, Maria Rosa Dewanti, Dani Gustaman Syarif, Muhamad Basit Febrian
{"title":"Dual Potential of Cetuximab Conjugated Hydroxyapatite Zirconium Nanoparticle as Nanocarrier for Radioenhancer in X-Ray Dynamic Therapy and <sup>177</sup>Lu-based Radioimmunotherapy of Lung Cancer.","authors":"Ahmad Kurniawan, Isa Mahendra, Asep Rizaludin, Marhendra Satria Utama, Ronny Lesmana, Fitria Dwi Ayuningtyas, Maria Rosa Dewanti, Dani Gustaman Syarif, Muhamad Basit Febrian","doi":"10.7150/ntno.101699","DOIUrl":"10.7150/ntno.101699","url":null,"abstract":"<p><p>This study aimed to synthesize cetuximab (CTX) conjugated hydroxyapatite zirconium (HApZr-CTX) as a nanocarrier for active delivery of photosensitizer and therapeutic radionuclide. The system enabled targeted radioenhancer in X-ray dynamic therapy and radioimmunotherapy for lung cancer. The results showed that HApZr-CTX had the main characteristics of hydroxyapatite crystal in X-ray powder diffraction (XRD), with particle size twice bigger, according to DLS-PSA and TEM measurements. Cellular ROS generation was elevated almost three times in A549 cells after being treated using 125 µg/mL HApZr-CTX and irradiated with 5 Gy of X-ray photon compared to untreated cells. The viability of the treated lung cancer cell line decreased after exposure to external radiation. Moreover, as a radioimmunotherapy candidate, <sup>177</sup>Lu was successfully loaded into HApZr-CTX nanocarrier and internalized in A549 more than half of the given dose after 0.5 h incubation. [<sup>177</sup>Lu]Lu-HApZr-CTX was primarily accumulated in the lung organs of healthy mice one-hour post-injection. In conclusion, HApZr-CTX nanoparticles have the potential to be used as a radioenhancer in X-ray dynamic therapy and radioimmunotherapy for lung cancer therapy.</p>","PeriodicalId":36934,"journal":{"name":"Nanotheranostics","volume":"9 1","pages":"82-94"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11898717/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NanotheranosticsPub Date : 2025-02-27eCollection Date: 2025-01-01DOI: 10.7150/ntno.106495
Pranjal Chandra
{"title":"Affordable and Sustainable Biosensing Technology.","authors":"Pranjal Chandra","doi":"10.7150/ntno.106495","DOIUrl":"10.7150/ntno.106495","url":null,"abstract":"<p><p>A growing need for rapid disease detection worldwide highlights the importance of innovative approaches to ensure prompt diagnosis and more effective patient care. As of now, various nanobioengineered systems have been developed and applied for disease diagnosis at an early stage, and a few are in clinical trials currently. However, the affordability and sustainability of diagnostic systems \"Biosensors\" are still being questioned in the translational research. To overcome these impediments and accelerate translational research, my laboratory is trying to develop sustainable, clinically relevant, nanobioengineered platforms for the detection of disease biomarkers at minimum cost.</p>","PeriodicalId":36934,"journal":{"name":"Nanotheranostics","volume":"9 1","pages":"63-66"},"PeriodicalIF":0.0,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11898718/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Structural Dynamics of OATP1A2 in Mediating Paclitaxel Transport Mechanism in Breast Cancer.","authors":"Rohit Kumar, Garima Singh, Yusuf Akhter, Gaurav Kaithwas, Ashish Kumar Agrawal, Sanjay Singh","doi":"10.7150/ntno.103095","DOIUrl":"10.7150/ntno.103095","url":null,"abstract":"<p><p>Breast cancer remains a significant global health challenge, with drug resistance and poor bioavailability of chemotherapeutic agents like paclitaxel (PTX) presenting obstacles to effective treatment. This study investigates the potential role of the Solute Carrier Organic Anion Transporter Polypeptide 1A2 (OATP1A2) in PTX transport using computational approaches. We employed computational modeling, molecular docking, and molecular dynamics (MD) simulations to elucidate the structural dynamics of OATP1A2 and its interaction with PTX. The OATP1A2 structure was modeled using Phyre2, validated, and refined. Molecular docking revealed significant PTX interactions within the predicted binding site, with a binding affinity of -10.4 kcal/mol and initial hydrogen bonding with Arg<sup>656</sup> and Gly<sup>560</sup> and hydrophobic interaction with atGlu<sup>66</sup>, Phe<sup>65</sup>, Asn<sup>41</sup>, Ala<sup>203</sup>, Ile<sup>204</sup>, Phe<sup>329</sup>, Phe<sup>332</sup>, Ile<sup>336</sup>, Pro<sup>207</sup>, Ser<sup>337</sup>, Asn<sup>334</sup>. Contrary to our initial hypothesis of inward drug movement, MD simulation over 500 ns revealed an unexpected outward movement of PTX. The ligand shifted approximately 5.4 Å towards the extracellular side from its initial binding position. This observation suggests a more complex transport mechanism than initially anticipated. The protein-ligand complex exhibited stability throughout the simulation, with notable conformational changes. Our findings highlight the complex nature of OATP1A2-mediated transport and its potential limitations for PTX delivery. These results accentuate the complexity of transporter-mediated drug delivery and may inform future strategies for improving chemotherapeutic efficacy in breast cancer treatment.</p>","PeriodicalId":36934,"journal":{"name":"Nanotheranostics","volume":"9 1","pages":"52-62"},"PeriodicalIF":0.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11898720/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Preparation and Characterization of Carbon Nanodots from turmeric soot for anti-coliform and anti-oral bacterial applications and as anti-staphylococcal coatings.","authors":"Arjun Prakash, Manikandan Muthu, Gnanadeepam Raja, Judy Gopal","doi":"10.7150/ntno.99825","DOIUrl":"10.7150/ntno.99825","url":null,"abstract":"<p><p>In an era where chemical synthesis of nanomaterial is accounting for the generation of toxic wastes, leading to nanotoxicity, the present work focuses on the extraction of carbon nanodots from available natural sources such as turmeric smoke. The extracted carbon nanodots were characterized and their physical and chemical attributes were confirmed. The antibacterial property of the isolated carbon nanodots was tested against coliforms and oral bacteria. The results indicated that the carbon nanodots possessed highly versatile antibacterial activity. Carbon coatings were prepared by dip-dry method from the turmeric smoke-derived nanodots. The carbon-coated glass surfaces showed biofilm-repellant activity when exposed to pathogenic Staphylococcal cultures. The bactericidal and antibacterial activity of the in-house extracted carbon nanodots was proved. This study introduces an ecofriendly and simple rapid carbon nanomaterial synthesis process from smoke which can be extended for various other applications too.</p>","PeriodicalId":36934,"journal":{"name":"Nanotheranostics","volume":"9 1","pages":"31-37"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142915840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrea Rubini, Federica Zanotti, Danilo Licastro, Giulia Calogero, Gisella Bettini, Cristiana Piccoli, Giuseppe Rubini, Luca Lovatti, Barbara Zavan
{"title":"Therapeutic Potential of Feline Adipose-Derived Stem Cell Exosomes in the Treatment of Feline Idiopathic Cystitis: A Characterization and Functional Analysis of miRNA Content.","authors":"Andrea Rubini, Federica Zanotti, Danilo Licastro, Giulia Calogero, Gisella Bettini, Cristiana Piccoli, Giuseppe Rubini, Luca Lovatti, Barbara Zavan","doi":"10.7150/ntno.99383","DOIUrl":"10.7150/ntno.99383","url":null,"abstract":"<p><p>Feline Idiopathic Cystitis (FIC), is a chronic lower urinary tract condition in cats analogous to PBS/IC in women, which presents significant treatment challenges due to its idiopathic nature. Recent advancements in regenerative medicine highlight the potential of Adipose Tissue-Derived Stem Cells (ADSCs), particularly through their secretome, which includes mediators, bioactive molecules, and extracellular vesicles (EVs). Notably, exosomes, a subset of EVs, facilitate cell-to-cell communication and, when derived from ADSCs, exhibit anti-inflammatory properties and contribute to tissue regeneration. In this work, we aim to characterize the content of exosomes derived from feline ADSCs (fADSCs) to elucidate their mechanisms of action on recipient cells and assess their therapeutic potential for FIC. Exosomes were isolated from fADSCs and their microRNA (miRNA) content sequenced using Illumina technology. Our findings demonstrate that fADSC-derived exosomes harbor miRNAs that can induce regenerative processes, such as cell proliferation, immune modulation, angiogenesis, and anti-inflammatory responses. Key miRNAs identified include fca-miR-221, fca-let-7f-5p, fca-miR-337-5p, fca-miR-542-5p, fca-miR-24-3p, fca-miR-205, and fca-miR-23a, which promote proliferative, angiogenic, differentiation, and regenerative mechanisms. Additionally, miRNAs with anti-inflammatory effects, such as fca-miR-193a-5p and fca-miR-127-3p, and those positively regulating the immune system, including fca-let-7a-5p and fca-miR-chrC1_18846-5p, were identified. Of particular interest, fca-miR-219-5p (has-miR-6766-3p) has been reported to suppress liver fibrosis.These results underline the therapeutic potential of fADSC-derived exosomes in treating FIC and suggest innovative strategies for feline veterinary medicine.</p>","PeriodicalId":36934,"journal":{"name":"Nanotheranostics","volume":"9 1","pages":"38-51"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667565/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914844","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ananda Kumar Chettupalli, Nihar Ranjan Kar, V T Iswariya, Uttam Prasad Panigrahy, Laliteshwar Pratap Singh, Harekrishna Roy, Deepadarshan Urs, Muralidharan V, Sandhya Rani Mandadi, M Akiful Haque, Ritesh Rana, Talha Bin Emran
{"title":"Development and optimization of dapagliflozin oral nano-bilosomes using response surface method: <i>in vitro</i> evaluation, <i>in vivo</i> evaluation.","authors":"Ananda Kumar Chettupalli, Nihar Ranjan Kar, V T Iswariya, Uttam Prasad Panigrahy, Laliteshwar Pratap Singh, Harekrishna Roy, Deepadarshan Urs, Muralidharan V, Sandhya Rani Mandadi, M Akiful Haque, Ritesh Rana, Talha Bin Emran","doi":"10.7150/ntno.99271","DOIUrl":"10.7150/ntno.99271","url":null,"abstract":"<p><p>In treating type 2 diabetes, avoiding glucose reabsorption (glucotoxicity) and managing hyperglycemia are also important. A metabolic condition known as diabetes (type-2) is characterized by high blood sugar levels in comparison to normal Bilosomes (BLs) containing Dapagliflozin (Dapa) were formulated, optimized, and tested for oral therapeutic efficacy in the current investigation. Used the Box Behnken design to optimize the Dapa-BLs, formulated via a thin-film hydration technique. Bile salts (X1) concentration, edge activator (X2) in mg, and non-ionic surfactant (X3) were the independent variables. The Entrapment Efficiency (Y1), Particle size (PS), polydispersity index (PDI), and zeta potential (ZP), were selected as dependent variables. To get the optimal formula, use Design-Expert® software for numerical optimization. The optimal bilosomal formula was selected by boosting %EE, ZP (absolute value), and <i>in vitro</i> drug release while also considering decreasing PS and PDI. <i>Ex vivo</i> skin permeation, Fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and scanning electron microscopy (SEM) were evaluate the optimized formulation. The <i>in vivo</i> pharmacodynamics activities of the optimized formula were examined on rats and compared to that of the oral Dapa solution. The optimized Dapa-BLs were shown a particle size of 155.36±2.48 nm and an entrapment efficiency of 86.37±2.6%. The SEM image showed a spherical particle with sharp boundaries. The drug release study revealed a significant enhancement in Dapa release (75.31 ± 2.68%) from Dapa -BLs as compared to drug solution (30.46 ± 3.64%). The results of the exvivo permeation and pharmacokinetic studies revealed a 4.49 times higher flux and 3.41 folds higher AUC<sub>0-t</sub> than drug solution. The antidiabetic activity results showed significant (P < 0.05) enhancement in therapeutic efficacy than drug solution. The results also showed marked improvement in biochemical parameters. Our findings suggested, the prepared Dapa loaded bilosomes was found to be an efficient delivery in the therapeutic efficacy in diabetes.</p>","PeriodicalId":36934,"journal":{"name":"Nanotheranostics","volume":"9 1","pages":"1-19"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142915836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Development and assessment of a novel magnetic nanoparticle antibody-conjugate and aptamer-based assay (MNp-Ab-Ap assay) for the rapid diagnosis of pleural tuberculosis.","authors":"Pratibha Sharma, Rakesh Kumar Gupta, Simran Aittan, Divya Anthwal, Manisha Dass, Rakesh Yadav, Ashish Behera, Abhijeet Dhiman, Sahajal Dhooria, Sunil Sethi, Ritu Singhal, Puneet Arora, Ashutosh Nath Aggarwal, Tarun Kumar Sharma, Sagarika Haldar","doi":"10.7150/ntno.95332","DOIUrl":"10.7150/ntno.95332","url":null,"abstract":"<p><p><b>Background:</b> Pleural tuberculosis (pTB) is a diagnostic challenge because of its non-specific clinical features, lack of accurate diagnostic tools and paucibacillary nature of the disease. <b>Methods:</b> We, here describe the development of a novel magnetic nanoparticle antibody-conjugate and aptamer-based assay (MNp-Ab-Ap assay) targeting 4 different <i>Mycobacterium tuberculosis</i> (<i>M</i>. <i>tb.</i>) antigens (GlcB, MPT51, MPT64 and CFP-10) for pTB diagnosis. The MNp-Ab-Ap assay was developed by conjugating polyclonal antibodies on the surface of magnetic nanoparticles (MNPs) by using EDC-NHS chemistry. These conjugated MNPs were used to capture <i>M. tb.</i> antigens present in the pleural fluid samples. The resulting antigen-antibody complex was detected by antigen-specific 5'-biotinylated aptamers. All assays were standardized using samples of the 'Development set' (n=17) and evaluated in the 'Validation set' (n=114) in a blinded manner. Patient categorization was done using a 'Composite Reference Standard'. Assay cut-offs were determined from the 'Development set' (n=17; 'Definite & Probable' pTB; n=9 and 'Non-TB'; n=8) by calculating mean+3SD of OD<sub>450</sub> values of the 'Non-TB' group and applied to 'Validation set' (n=114; 'Definite' pTB; n=8, 'Probable' pTB; n=34, 'Possible' pTB; n=28 and 'Non-TB'; n=44). <b>Results:</b> Out of the 4 assays, MPT51-based MNp-Ab-Ap assay performed the best with 66.6% (95%CI;50.4-80.4) sensitivity and 95.4% (95%CI;85.1-99.4) specificity in the combined 'Definite and Probable' pTB group. Xpert MTB/RIF assay detected only six samples in the 'Validation set'. Binary logistic regression analysis indicated that MPT51-based MNp-Ab-Ap assay provided an incremental advantage over the existing diagnostic algorithm for pTB. <b>Conclusions:</b> We conclude that MPT51-based MNp-Ab-Ap assay is a novel technique that can pave the way towards rapid and accurate diagnosis of pTB.</p>","PeriodicalId":36934,"journal":{"name":"Nanotheranostics","volume":"9 1","pages":"20-30"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667566/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142915814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}