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Product line testing is significant because any faults in a product line platform can lead to widespread impacts on multiple products configured from that platform within a product line. Due to the shared platform, certain testing can be repeatedly performed across different products, leading to unnecessary costs. To enhance quality and reduce costs in product line testing, it is essential to minimize redundant testing of the products in a product line. Because test coverage provides a way to explicitly state the extent to which a software item has been tested, having a clear understanding of test coverage helps avoid unnecessary repetition of tests and ensures that the testing efforts are focused on areas that require attention, ultimately leading to more efficient and effective product line testing. It is necessary to define appropriate test coverage metrics of product line testing that enable testers to identify redundancies in their testing efforts. Path-based integration testing has been proven to be an effective approach to product line integration testing. This paper defines coverage metrics for path-based product line integration testing and demonstrates their effectiveness in preventing redundant testing between platform testing and testing for individual products, while also effectively detecting faults. The experiment results highlight the coverage metrics’ effectiveness in avoiding redundant testing, reducing costs, and covering interfacing across different modules.

Currently, malaria rapid diagnostic tests (RDTs) are widely used for malaria diagnosis, but test performance and the factors that lead to failure of Plasmodium ovale detection are not well understood. In this study, three pLDH-based RDTs were evaluated using cases in China that originated in Africa. The sensitivity of Wondfo Pf/Pan, CareStart pLDH PAN and SD BIOLINE Pf/Pan in P. ovale detection was 70, 55 and 18%, respectively. CareStart was worse at detecting P. o. curtisi (36.5%) than at detecting P. o. wallikeri (75.0%), and SD could not detect P. o. curtisi. The overall detection ratio of all three RDTs decreased with parasite density and pLDH concentration. Wondfo, CareStart and SD detected only 75.0, 78.1 and 46.9% of the P. ovale cases, respectively, even when the parasitemia were higher than 5000 parasites/μL. Subspecies of P. ovale should be considered while to improve RDT quality for P. ovale diagnosis to achieve the goal of malaria elimination.

BackgroundMycoplasma contamination poses a persistent challenge in biopharmaceutical production, threatening both cell viability and patient safety. Conventional detection methods, such as culture and indicator cell assays, require up to 28 days for completion, delaying product release and increasing operational risk. These methods also depend heavily on consistent laboratory conditions, reducing reliability in detecting low-level contamination. Recent advances in molecular diagnostics have provided efficient alternatives, enabling sensitive and specific detection of mycoplasma DNA within a few hours. Recognized by major pharmacopeias, qPCR is increasingly adopted in the release testing of monoclonal antibodies, cell therapies, and viral vectors. Driven by the growing need for rapid and reliable contamination control, qPCR-based methods offer several advantages: short assay time, integration with automated workflows, and compatibility with complex sample matrices. In this study, we assess a validated qPCR assay developed under GMP-like conditions for its ability to detect over 250 mycoplasma species, supporting its application in regulated environments and high-throughput manufacturing settingsMethodsTo evaluate mycoplasma contamination with high sensitivity and specificity, we utilized a streamlined workflow integrating ACROBiosystems’ Automated Nucleic Acid Extraction instrumentation and Mycoplasma Sample Preparation and qPCR Quantitative Detection Kit, as outlined in the schematic overview (figure 1). The following section details the experimental procedures and control strategies employed throughout the assay.ResultsTo validate the performance of the ACROBiosystems Mycoplasma Quantitative Detection Kit, we followed international guidelines outlined by EP <2.6.7>, USP , JP, and the Eurofins Biopharma Product Testing framework for NAT comparability studies. The evaluation covered all essential parameters, including specificity, sensitivity, positive cut-off, and robustness, in alignment with regulatory expectations for nucleic acid-based mycoplasma detection.ConclusionsThis research workflow demonstrates that the ACROBiosystems qPCR-based mycoplasma detection method is a reliable alternative to conventional compendial assays, meeting key validation criteria outlined in EP <2.6.7>, USP , and JP guidelines. The assay consistently achieved a detection limit of 10 CFU/mL across multiple mycoplasma strains, fulfilling the positive cut-off requirement of ≥95% detection in replicate testing. The method showed high specificity, with no cross-reactivity observed in unrelated cell lines or microbial strains, and demonstrated robustness against variations in reagent concentrations, extraction procedures, and qPCR instrumentation. In addition, the assay maintained performance in complex sample matrices, including those with high cell density and cryoprotectants such as DMSO.

Sport and sport equipment are permanently subject to innovation. The current research on innovation sources in sport industries has focused on user innovation and firm-internal sources of innovation. This paper uses the network approach to analyze external links as sources of product innovation in nautical sport clusters. It addresses the question: how can sport organizations effectively use interorganizational links for innovation? An empirical study identifies and compares innovation practices in the Auckland sailing cluster in New Zealand with the Victorian surfing cluster in Australia. In total 52 firms, non-profit-organizations, and governing bodies were interviewed. In spite of much existing research focusing on internal firm resources and end users as sources of innovation in the sport sector, interorganizational linkages provide rich sources of innovation for organizations located in clustered sport industries. This research identifies 11 practices that can be imitated by other organizations located in sport clusters or similar settings. Eight practices occur in both clusters while three only occur in one of both. This paper contributes to knowledge on mechanisms for information and knowledge transfer that leverage innovation via interorganizational linkages.

Malaria rapid diagnostic tests (RDTs) emerged in the early 1990s into largely unregulated markets, and uncertain field performance was a major concern for the acceptance of tests for malaria case management. This, combined with the need to guide procurement decisions of UN agencies and WHO Member States, led to the creation of an independent, internationally coordinated RDT evaluation programme aiming to provide comparative performance data of commercially available RDTs. Products were assessed against Plasmodium falciparum and Plasmodium vivax samples diluted to two densities, along with malaria-negative samples from healthy individuals, and from people with immunological abnormalities or non-malarial infections. Three measures were established as indicators of performance, (i) panel detection score (PDS) determined against low density panels prepared from P. falciparum and P. vivax wild-type samples, (ii) false positive rate, and (iii) invalid rate, and minimum criteria defined. Over eight rounds of the programme, 332 products were tested. Between Rounds 1 and 8, substantial improvements were seen in all performance measures. The number of products meeting all criteria increased from 26.8% (11/41) in Round 1, to 79.4% (27/34) in Round 8. While products submitted to further evaluation rounds under compulsory re-testing did not show improvement, those voluntarily resubmitted showed significant increases in P. falciparum (p = 0.002) and P. vivax PDS (p < 0.001), with more products meeting the criteria upon re-testing. Through this programme, the differentiation of products based on comparative performance, combined with policy changes has been influential in the acceptance of malaria RDTs as a case-management tool, enabling a policy of parasite-based diagnosis prior to treatment. Publication of product testing results has produced a transparent market allowing users and procurers to clearly identify appropriate products for their situation, and could form a model for introduction of other, broad-scale diagnostics.

Introduction: Malaria is a life-threatening disease caused by infection with Plasmodium parasites. Rapid diagnostic tests (RDTs) have been used for the diagnosis of malaria without special equipment by unskilled personnel over the last 15 years. The treatment should only be given after the clinical diagnosis confirmed by RDT or microscopy. RDTs' specificity and sensitivity have been reported as >95% by the World Health Organization - Foundation for Initiative New Diagnostics (WHO-FIND). Case Report: A 30-years-old male and a 23-years-old female presented to our emergency department with fever and history of a visit to a malaria-endemic country. Plasmodium trophozoites were seen in the blood smear samples via light microscopy. However, RDTs were negative. The patients were treated according to their pathogens. Conclusion: Rarely, RDT might result in a false negative in the diagnosis of malaria. People travelling to endemic areas should be closely monitored. Emergency department physicians should not neglect microscopy which is the gold standard for diagnosis of malaria.

The extracellular matrix (ECM) comprises a complex milieu of proteins and other growth factors that provide mechanical, biophysical, and biochemical cues to cells. The ECM is organ specific, and its detailed composition varies across organs. Bioinks are material formulations and biological molecules or cells processed during a bioprinting process. Organ-derived decellularized ECM (dECM) bioinks have emerged as arguably the most biomimetic bioinks. Here, we review bioinks derived from different decellularized organs, the techniques used to obtain these bioinks, and the characterization methods used to evaluate their quality. We emphasize that obtaining a good-quality bioink depends on the choice of organ, animal, and decellularization method. Finally, we explore potential large-scale applications of bioinks and challenges in manufacturing such bioinks. Many individual ECM components, including collagen, fibrin, gelatin, alginate, and others, have been used as bioinks, but the natural ECM offers many physical, chemical, and biological cues that are difficult to recapitulate using only a single or just a few components. dECM bioinks could be revolutionary in terms of offering a complete biomimetic ink. dECM bioinks could be used to print more functional and relevant tissues, which would have applications for drug screening, disease modeling, and regenerative medicine. A dECM bioink is a softer material with lower mechanical strength; therefore, to ensure the integrity of the bioprinted structure, it is important to fine-tune the mechanical properties of this bioink by mixing it with either natural or synthetic materials.

Effective regulation and control of tobacco products require robust laboratory testing capabilities to ensure quality, safety and compliance with relevant standards. Currently, no standardized assessment tool exists globally to evaluate the tobacco testing laboratories. This study aims to address this gap by developing the Tobacco Testing Laboratory Assessment Tool (TTLAT). This tool aligns with the WHO-FCTC on Tobacco Control's Article 9, which calls for the adoption and implementation of effective testing, measuring, and regulation measures. The TTLAT was developed through a systematic literature review and a two-round Delphi technique involving 24 experts. The tool was then validated in four National Tobacco Testing Laboratories in India. Content validity was assessed using the Item-Content Validity Index (I-CVI) and Scale-Content Validity Index (S-CVI). Construct validity was evaluated through exploratory and confirmatory factor analyses. Internal consistency reliability was measured using Cronbach's alpha. The final TTLAT comprises 213 items across 11 critical domains including General Information (17), Documents (37), Organization and Management (10), Human Resources (28), Infrastructure (7), Equipment (23), Consumables and Reagents (10), Sample Handling (17), Tobacco Product Analytes (8), Data Management (36), and Biosafety and Biosecurity (20). Content validity analysis showed excellent results. Exploratory factor analysis identified six factors accounting for 52.5% of the total variance. Confirmatory factor analysis demonstrated good model fit (CFI = 0.91; TLI = 0.90; RMSEA = 0.05; SRMR = 0.06). The tool showed high internal consistency reliability across factors (Cronbach's alpha 0.72-0.92). The TTLAT demonstrates strong psychometric properties and provides a comprehensive, standardised approach for assessing tobacco testing laboratory capacity.