We thank Seegene Technologies for providing Novaplex SARS-CoV-2 Variants I, II, and IV assay kits used in this study. However, a summary table (Supplemental Table S3) shows the potential capabilities of different assays developed by Seegene Technologies. Predominant variants need to be well characterized and expeditiously tracked to facilitate vaccine and therapeutic development and help protect public health by establishing appropriate control and mitigation measures. Some variants have also been shown to decrease the efficacy of available therapeutics, such as monoclonal antibodies, as most recently witnessed with the Omicron variant surge. Since the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in early 2020, new variants of interest and concern have emerged throughout the world.1,2 There was 100% (109/109) overall agreement (95% CI, 96.7%–100%) between the spike gene sequencing and the I,II&IV results using extracted RNA for the variants included in the Novaplex assay menus. Tracking new and emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants has become increasingly important for public health responses, primarily because of variant-dependent transmission, disease severity, and treatment decisions. Improve efficiency and create consistent professional on brand documents every time with this easy to use software. “Docs and the other software we use from Novaplex are high-quality products that don’t cost a lot of money considering how much we use them and the volume of documents people are generating,” he says. Docs integrates with the firm’s document management system (DMS) iManage10, which improves the process for fee earners by reducing potentially billable time wasted completing routine tasks. Knowing that there was an in-house developer, Robertson adds, meant lawyers frequently asked for changes to be made to their documents, which was an ineffective use of his time. Our software removed the risk of users sending out old and incorrect document content.” adds Michelle Langton, Managing Director, Novaplex. “Novaplex’s value to clients is more than providing intuitive document template software to improve productivity; we also provide expertise to businesses during significant changes such as these. Of the 156 samples, only 17 were identified as wild type by S gene sequencing (Table 2). WT indicates samples selected with no spike gene mutations other than D614G, which was detected by S gene sequencing. Of the other two samples, only the RdRp gene was detected in one, and only the H69/V70 deletion was detected in the other. In two of the samples, only the N501Y mutation and RdRp gene were detected. South Korea's Seegene Develops Advanced Multiplex PCR Assays for Mpox and Other Viruses Taken together, our data demonstrated that NovaplexTM assay yields superior malaria diagnostic outcome compared to conventional diagnostic methods such as RDT and microscopy. A more sensitive PCR leads to the detection of more low-density infections, resulting in lower sensitivity for microscopy, RDT, and even alternative qPCR methods like the Novaplex TM assay. In this study, compared to qPCR, mRDTs did not detect 36.6%52/142 of PCR-positive malaria infections while microscopy did not detect 34.5%49/142 of PCR-positive malaria cases. DRAWBACK OF SLOW DOCUMENTS CREATION Each reaction mixture contained 8 µL of extracted nucleic acid and 17 µL of one-step RT-PCR master mix (5× RP MOM, 5 µL of RNase-free water, 5 µL of 5× real-time one-step buffer, and 2 µL of real-time one-step enzyme) at a final volume of 25 µL. This study was conducted at Kangdong Sacred Heart Hospital, Seoul, Korea, during the non-influenza season (August 2019 to December 2019). The viral targets detected by BioFire FilmArray RP include AdV, human coronavirus (HCoV 229E, NL63, OC43, and HKU1), MPV, FluA, FluA-H1, FluA-H3, FluA-H1-2009, FluB, PIV-1, PIV-2, PIV-3, PIV-4, HEV/HRV, and RSV-A/B. Publication types The main purpose of this research study was to perform immunosurveillance and evaluate performance rapid diagnosis test for malaria parasites in Meru South Sub-County, Tharaka-Nithi County. The use of antigen-detecting rapid diagnostic tests (RDTs) is a vital part of this strategy, forming the basis for extending access to malaria diagnosis by providing parasite-based diagnosis in areas where good-quality microscopy cannot be maintained. The diagnostic methods used to diagnose malaria include microscopy, rapid diagnostic test and molecular techniques. The performance of these malaria kits was compared to microscopy, the gold standard, for the detection of malaria parasites. The Clade 1b variant, more transmissible and deadly, has been reported outside Africa, including in Sweden, Pakistan, the Philippines, and Thailand. The WHO declared mpox a PHEIC in July 2022 due to its international spread, though the status was lifted in May 2023 as cases declined. In 2022, Seegene developed the Novaplex MPXV (RUO) assay using its advanced Seegene Digitalized Development System (SGDDS). The Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO) is particularly notable for its ability to detect mpox alongside other major pathogens causing sexually transmitted infections (STIs). Assuming that the sensitivity of Anyplex in the study population is transferable to a screening population, and that HPV prevalence detected by Cobas 4800 is comparable to that detected by Anyplex set A, the PPV of medium and high viral load in Anyplex set A would be 20%, and NPV would be expected to reach 100%. In a small study of 94 samples from routine screening, clinical performance of Anyplex set A was compared with that of the Cobas 4800 Test. Such a diagnostic artifact was found in a study regarding HPV16 and 52 and must be considered in a post-vaccination population . Most HPV DNA genotyping tests have consensus primer PCR assays in the conserved parts of the L1 viral region, where the most prevalent HPV types, especially HPV16, might mask other HPV types present and lead to false-negative tests for these HPV types. Anyplex is one of very few commercial tests that can genotype more than HPV16 and 18 in a simple, PCR-based, real-time assay, and can be used in measuring vaccine impact among women attending cervical cancer screening and to stratify the impact of other genotypes by risk of cervical disease in the absence of the seven most oncogenic types. The sensitivity of Proofer in previous studies was 70.6–78.1%, and specificity was 70.8–75.5%, which is comparable to our findings 15, 16, 20. We found a slightly higher inter-rater agreement, which might be explained by the higher prevalence of HPV and dysplasia in our study population, with a viral load that was detectable by both tests. The observed specificity for Anyplex set A and HC2 in our study was higher than earlier reports 15, 20. When we restricted to medium and high viral loads of the hrHPV types in Anyplex set A, the specificity increased, without loss of sensitivity. The Allplex RP operates on the Seegene workflow, consisting of a module for nucleic acid extraction and PCR setup, a 96-well PCR thermocycler, and a computer for data analysis and interpretation of results. For adenoviruses, Allplex RP 1 detected 31 specimens, compared to 34 by the BioFire FilmArray. Co-infection with two or more viruses was detected in 41 and 17 NPS specimens by Allplex RP and the BioFire FilmArray RP, respectively. We evaluated Allplex Respiratory Panel (RP) 1, 2, 3, and the BioFire FilmArray RP assay for detecting respiratory pathogens from NPS specimens. The quality of the documents your firm sends to clients and prospects is a key element of the service provided. Seegene Develops New PCR Tests Amid Global Resurgence of Mpox “I would argue that these two particular areas are vital for law firms — not only giving the clients a professional-looking document but also making sure what they receive is safe and secure, uncompromised in any way,” explains Bennett. “Your reputation is only as good as your last document or email,” notes Bennett. “The Novaplex team is very easy to talk to, if you want to ask about a specific document production issue, they will have advice and guide you.” In the initial phase of rolling out these products, Novaplex worked closely with Birkett Long to understand its house style and document management needs, Bennett explains. As samples with MPXV Cq values greater than 31 contain diluted genetic material, their respective RNase P target (assay internal control) values were high, leading to a larger standard deviation (STDEV). Using a PCR product corresponding to the TNF-α receptor gene region (also designated MPX gp180 or J2R CDS), the assay sensitivity was evaluated. Since we combined 3 reactions, we sought to ensure that the sensitivity of the multiplex assay was retained. The RF signal of the in-house and Bio-Speedy assays ranged between 5,000 and 10,000 RFU, while the signal in the Novaplex assay was less than 600 RFU. While the 2 commercial kits were able to detect specimens with low viral loads similarly to the in-house assay, significant differences were observed, in the Cq values and relative fluorescence (RF), between the assays. Furthermore, of the 55 HRV-positive NPS specimens on the Allplex RP 3 assay, 26 were HEV/HRV-negative by the BioFire FilmArray RP assay. Compared with the Allplex RP 1, 2, and 3 assays, the BioFire FilmArray RP assay contains an additional respiratory target, that is, M. For HEV/HRV detection, the best performance was achieved by the Allplex RP 2 and 3 (35.3%) compared to the BioFire FilmArray RP assay (21.5%). However, 12 HEV and 26 HRV-positive NPS specimens on the Allplex RP 2 and 3 were not detected by the BioFire FilmArray RP assay. Finally, the diagnostic specificity was tested on only 10 samples and was 100% for all MPXV RUO assays. Likewise, antigen and antibody assays may not be useful as laboratory procedures for mpox because orthopoxviruses are serologically cross-reactive . Assays based on TMA potentially increase sensitivity of detection compared to assays based on RT-PCR targeting single-copy genes 10–15. Trachomatis (37 samples; 5.9% using TMA assays) and the anatomical site with the highest prevalence of microorganisms was a non-urogenital site, the pharynx (27 positive samples; 4.3%). A total of 88 (14.1%) and 66 (10.6%) positive samples were found for any of the TMA assays used and for the RT-PCR assay, respectively. Associate News is provided by Legal Futures Associates. Once you use it a couple of times, it's really easy to do the necessary tasks, ie - signing documents, combining multiple files into one pdf...Reduce the time taken to produce and edit business documents, ensuring reliability of numbering, styles and formatting.Only 60.6%86/142 were diagnosed with clinical malaria at the health centers, which is highly contrasted with a positivity of 90.8%129/142 by Novaplex® assay, and 95.1%135/142 by qPCR.As this study was not designed to assess the sensitivity and specificity of RP assays, no conclusions have been drawn.This discordant sample was not repeated due to lack of eluates, so we were unable to assess if there was a sampling error or if the assay was not able to correctly identify this variant.SARS-CoV-2, like all viruses, generates random mutations during viral replication, resulting in genetic variation among circulating viral populations.Here, we evaluated the diagnostic performance of four real-time qualitative PCR assays for the laboratory diagnosis of mpox (monkeypox) monkeypox disease. All individuals presenting with suspected malaria infections (febrile illness) were screened using microscopy and RDTs as potential participants in the study. The Novaplex™ malaria assay is a qPCR-based kit that seeks to narrow this gap by providing an optimized diagnostic solution capable of species-specific diagnosis by distinguishing the plasmodium species present in malaria infection. There is also variance in the analytical sensitivity of different hrp2-based and Pan LDH- based RDT with limit-of-detection for pLDH based RDTs being significantly higher than those of hrp-2 based RDTs . We visually checked the Allplex RP assay results for the Ct value and amplification curve; however, we could not determine the low amplification curve and positivity for the NPS specimens. This suggests that despite the low Ct values of HRV in the Allplex RP 3 assay, the BioFire FilmArray RP could not detect HEV/HRV in the five NPS specimens. For example, five NPS specimens (no. 24, 38, 44, 78, and 88) were found HEV/HRV-negative in the BioFire FilmArray RP assay with Ct values Figure 3). Backed by over 20 years of experience in native cloud innovation, NetDocuments offers a complete end-to-end platform for document and email organisation and management, including award-winning security and research capabilities; robust automation, collaboration and search technologies; and seamless integrations with other tools professionals use daily.The WHO declared mpox a PHEIC in July 2022 due to its international spread, though the status was lifted in May 2023 as cases declined.As the results of samples with similar or lower DNA concentrations were not as variable, this cannot be explained by differences in the kit quality.This somewhat limits the ability to assess the robustness of the assays, as different samples may contain different compositions of inhibitors that can affect the test results.Recently, some of these assays received the CE-IVD certification (i.e., RealCycler MONK-UX/MONK-GX v.2; Bio-Speedy Monkeypox Virus qPCR kits and BGI Genomics Monkeypox Virus Nucleic Acid Detection Kit).We are grateful to the South African National Health Laboratory Services (NHLS) and Inqaba Biotech (South Africa) for their generous provision of Illumina-sequence-confirmed COVID-19 clinical samples and Allplex Variant Typing kits, respectively.Birkett Long also uses two other Novaplex solutions, Metaminder and Threadprint, to enhance document security and compliance and operate sustainably.In addition, the surveillance samples originate from 5 areas of the U.S., each including multiple submitting pathology laboratories allowing our results to be more generalizable, as variations in tissue processing that could impact fixation and assay sensitivity, are included. Seegene’s Executive Vice-President and Chief Global Sales and Marketing Officer, Daniel Shin, emphasized the company’s commitment to collaborating with global governments to meet market needs for effective assays. The newly introduced assays, Novaplex™ MPXV/OPXV Assay (RUO) and Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO), are designed for research use only. Tiger Eye, the full-service iManage Partner, has today 25th July announced a strategic partnership with Novaplex, a UK-based provider of software solutions for document creation and automation. IManage integration is included in all our solutions, and that combination means Tiger Eye can now offer all the software firms need throughout the document lifecycle, from creation, through drafting and onto final disposition.” Novaplex’s Template Studio suite includes software for managing documents, presentations, Excel workbooks and document printing. SEOUL, South Korea, June 28, 2022 /PRNewswire/ -- Seegene, Inc. (KQ965390), South Korea's leading molecular diagnostics (MDx) company has developed a PCR test to detect the monkeypox virus. Transform software is document fixing and styling software and has become an essential tool for lawyers who are having to be self-sufficient styling their own documents, without the usual secretarial and expert user help available. Global world class document solutions and presentation & pitch software that help law firms win big business and more – all with a service you would expect from only the best in class. Novaplex is the UK's top independent software brand supplying legal professionals with the most up to date solutions for all document creation and data security needs. These Terms and Conditions, together with any other documents referred to herein, set out the terms of use governing your use of this website, (“Our Site”). Assuming that the sensitivity of Anyplex in the study population is transferable to a screening population, and that HPV prevalence detected by Cobas 4800 is comparable to that detected by Anyplex set A, the PPV of medium and high viral load in Anyplex set A would be 20%, and NPV would be expected to reach 100%.The assay was validated using variable nucleic acid of COVID-19 samples including Alpha, Beta, Gamma, Delta, and Omicron cases.DENV-1 RNA preparations were made by the Italian Institute of Health within a national quality control program for DENV diagnostics.Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants have received increasing attention globally because of their increased transmissibility and potential to escape immunity.Table 1 shows a detailed description of the anatomical location of the collected samples.The MPOX outbreak in the USA during 2003 prompted the development of several molecular assays, using somewhat different technologies with varying specificities toward orthopox species and monkeypox in particular (10–14).Considering only the HPV tests that included genotyping (Anyplex and Proofer), there were some discrepancies in the detection of HPV16, 18, 31, 33, and 45. Seegene's assay development is aimed at controlling the mpox outbreak and supporting the company's. Head-to-head comparison between qPCR assays False positive or false negative results with either assay cannot be excluded, however the reference assay has been extensively used in surveillance studies. This may impact HPV typing results particularly for assays relying on large amplicons, such as LA (450 bp amplicon). A goal of this validation study was to determine the effect that shifting to a new typing assay would have on efforts to monitor impact of the HPV vaccination program. The software was also written in a foreign language and lacked a support agreement, making its maintenance complex and frustrating, says Bennett. This led to compatibility issues and data corruptions when sending documents, hampering the productivity of lawyers and the firm as a whole. The previous software, created by a third-party company several years ago, began to show its age as it struggled to keep pace with newer versions of Word. Novaplex and NetDocuments will both be integrated with this, which will enable easy access to templates and documents both within and outside the new CMS, enhancing workflow efficiency. Negative tests with a positive internal control were not re-analyzed, neither were samples with negative HC2 results, since this test has no internal control. The test is a multiplex real-time PCR assay utilizing dual priming oligonucleotide and tagging oligonucleotide cleavage and extension technology. The test does not include genotyping, thus a positive test refers to detection of one or more of the included HPV types. Recently, a semi-quantitative, real-time multiplex PCR assay called Anyplex II HPV28 (hereafter referred to as Anyplex; Seegene, Seoul, South Korea) became available. Greatly decrease the time taken to produce and edit presentations in the correct styles and formats. “Content” means any and all text, images, audio, video, scripts, code, software, databases, and any other form of information capable of being stored on a computer that appears on, or forms part of, Our Site; and We would also like to thank all staff of Ndlovu Research Centre and Laboratories for assisting on the study. Comparative evaluation of the Novaplex kit. Samples from consenting participants that tested positive using both RDT and microscopy were enrolled as positive study samples while those that tested RDT negative and showed no malaria parasites on slide microscopy were enrolled as negatives pending PCR confirmation. Seegene Inc., a leading provider of total solution for PCR molecular diagnostics based in South Korea, announced today that it will introduce a new type of research-use-only (RUO) PCR assay to address the spread of the mpox virus variant, Clade Ib, which is currently prevalent in Africa. Whole blood samples were collected, Plasmodium parasite positivity and species identification were performed using microscopy, rapid diagnostic kits, the NovaplexTM malaria diagnostic assay, and qPCR. This study, which was carried out in the context of the internal optimization of the diagnostics of arboviruses, aimed to evaluate performance of five RT2-PCR kits for the detection of DENV in sera samples. These products also comply with TPPs issued by the WHO.'As the spread of mpox continues unabated, we have developed new RUO assays for detection of viruses causing the mpox to meet the increasing research demand from affected countries. Due to constrains in workflow, the reference assay was always performed before the Novaplex assay. Interpretation of certain LiPA probes is ambiguous for determination of a specific HPV type without additional probes to resolve ambiguity. To monitor for DNA contamination, four nuclease-free water aliquots were processed in parallel with FFPE samples in 96-well plates. The tissues were further lysed by adding 20 μL of Proteinase K solution (16 μg/μL), samples vortexed for 3-5 seconds and then incubated overnight at 65°C for 16 hours. After 5 minutes of incubation, paraffin was melted from FFPE samples, and the contents of the tube were mixed by finger-flicking to ensure the tissues are submerged in the Lysis Buffer Tissue. Accuracy, sensitivity and specificity of the RT2-PCR kits for the detection of dengue virus in clinical samples, by diagnostic accuracy parameter and assay. The Novaplex™ assay exhibited a sensitivity of 95.5%, specificity of 87.5%, and an accuracy of 95.1%, surpassing microscopy and RDT's detections significantly. This monitoring has enabled the company to create tests that screen the majority of virus variants that have been discovered globally, using Seegene's existing COVID-19 assays. Cross-reactivity specificity testing of the Variants II assay with 20 non- Beta and Delta SARS-CoV-2 positive samples obtained in 2020, before emergence of those variants. Twenty-five clinical samples were tested in five RT2-PCR assays, of which fifteen (60%) were known to be positive. The goal of this study was to assess the diagnostic accuracy of five different RT2-PCR kits for the detection of DENV in a historically processed set of sera samples. This system leverages Seegene's expertise in rapidly developing and deploying new diagnostic assays.The global spread of mpox, which was once limited to Africa, has led to increasing demands for accessible treatments, particularly in developing countries. The HPV typing results from Novaplex were interpreted following manufacturer’s recommendation with the exception that detection of any of the 28 HPV types was sufficient to consider the samples HPV-positive regardless of the detection status of internal control. Based on Anyplex results, HPV16 was the most common type, being present in -28.7% of women, followed by HPV31, 52, 18, 33, and 45 in 17.2%, 12.8%, 11.8%, 8.8%, and 7.1%, of the study sample, respectively.Accuracy, diagnostic sensitivity and specificity were 100% for the Novaplex MPXV Assay and RealStar Orthopoxvirus PCR Kit 1.0.In Kenya, microscopy and RDTs are the most commonly used diagnostic tools for routine care in health centers.A. Cross-reactivity specificity testing of the Variants II assay with 48 non-SARS-CoV-2 respiratory pathogens.NovaplexTM MPXV/OPXV Assay (RUO) is designed to detect pathogens caused by Orthopox-viruses, including Clades 1 and 2 of the mpox virus.The observed specificity for Anyplex set A and HC2 in our study was higher than earlier reports 15, 20.The production of documents can be time consuming if you don't have the right document templates, with styling and branding to support your business.Tracking new and emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants has become increasingly important for public health responses, primarily because of variant-dependent transmission, disease severity, and treatment decisions.A document template, automation or content solution should not limit the functionality of MS Word or any other core business system. Tiger Eye, the full-service iManage Partner, has today, 25 July, announced a strategic partnership with Novaplex, a UK-based provider of software solutions for document creation and automation. For more information on Novaplex software products; Template Studio, Template Studio Print and Threadprint please contact Michelle Langton, Managing Director of Novaplex Ultimately these solutions have provided an inflexible working model not suited to the changing needs of a law firm environment which, ironically, results in a worse situation where fee earners find workarounds such as copying old non-standard documents to save time. The study was supported by the Liaison Committee between the Central Norway Regional health Authority (RHA) and the Norwegian University of Science and Technology (NTNU). Our findings indicate that extended genotyping beyond HPV16 and 18 will lead to a more precise risk stratification for CIN2+ and CIN3+ and a more precise risk based follow-up of HPV positive women. Restricting Anyplex to the 7 hrHPV-types 16, 18, 31, 33, 45, 52 and 58, satisfy the international criteria for the sensitivity of HPV tests in primary screening for CIN2+. Our findings confirm the clinical sensitivity of Anyplex, as non-inferior to HC2, and thus indicate that the storage did not influence the performance of Anyplex. Comparison of the results showed high intra-assay agreement between laboratories, with small variations for most samples.The Novaplex assay detected more HPV types than the reference assay regardless of the HPV groups analyzed; McNemar’s p-value was less than 0.05 for all foure HPV groups.In summary, among the 181 NPS specimens tested, the Allplex RP 1, 2, and 3 assays detected 154 samples positive for respiratory viruses, whereas the BioFire FilmArray RP detected viruses in 98 samples.An intuitive template solution from Novaplex significantly reduces the time BDB Pitmans lawyers spend creating and formatting documents.This assay provides reliable test results with broad coverage, detecting type 1 and type 2 of herpes simplex virus (HSV), as well as varicella-zoster virus (VZV) that exhibit symptoms similar to the mpox virus using the multiplex PCR testing.Oliver Schofield, Head of Technology for Lubbock Fine commented “Despite the additional challenges of the past year, not only did we complete a major upgrade to iManage 10 but also converted the business to an LLP which involved a considerable update of our existing business documentation.”At Relativity, we make software to help users organize data, discover the truth, and act on it.The main limitation of the Allplex RP assay is the absence of M.Type-specific concordance and sample concordance between reference assays and Novaplex were determined for four groups (HPV 16/18, 9v, 14HR and 21HPV). Productivity & Efficiency There was 100% (109/109) overall agreement (95% CI, 96.7%-100%) between the spike gene sequencing and the I,II&IV results using extracted RNA for the variants included in the Novaplex assay menus. While sensitivity of the Novpalex assay was 100% the sensitivity of the other assays was lower; 94% for the Bio-speedy assay and G2R assay and 88% for the genericWA assay. The transition to Novaplex’s Template Studio software significantly modernised the firm’s document production, reducing the time spent on document creation and enhancing overall document quality, aligning it with the Birkett Long brand. With MS Office now being nearly thirty years old, clients now fully expect their fee earners to be able to produce professional looking documents at all times. Experience the ease of accelerated document generation and discover how you can reclaim your time and reduce complexity. Novaplex transforms document generation by prioritising speed, saving valuable time, and simplifying your workday. Today, Seegene is able to rapidly develop new tests ahead of emerging variants using the company's big data auto-surveillance in silico system. However, you can only use it on one machine at a time. To get a future upgrade, you will need to purchase the software again. This means you own the specific version of software you bought on your date of purchase. Power PDF, PaperPort and OmniPage desktop products are perpetual licenses and not subscriptions. With tools to build, deploy, and manage AI solutions at scale, Airia helps legal and corporate teams improve efficiency while meeting strict regulatory and ethical standards. Backed by over 20 years of experience in native cloud innovation, NetDocuments offers a complete end-to-end platform for document and email organisation and management, including award-winning security and research capabilities; robust automation, collaboration and search technologies; and seamless integrations with other tools professionals use daily. For 30 years, Litera has partnered with the world’s most innovative law firms to transform the attorney workflow experience with market-leading software and cutting-edge AI solutions. Another potential limitation is that Anyplex was performed retrospectively on DNA samples kept frozen up to 3 years at -80°C. A limitation of the study is the small number of women without CIN2+, so caution should be taken in drawing conclusions about the specificity of Anyplex in a screening population. As the prevalence of hrHPV will fall due to HPV vaccination and women repeatedly screened with HPV tests, the PPV of a positive HPV test will be even further reduced. If a firm wants to add new or change existing templates this should only take the time it takes to create the new template layout and upload into the existing environment. For a solution to provide true business benefits it must accommodate for change without the need for excessive additional project time or services costs. A document template, automation or content solution should not limit the functionality of MS Word or any other core business system. Previous document template and production solutions have demonstrated that simplicity and autonomy are essential. In such areas RDTs provide an alternative diagnostic method since they do not require highly trained personnel and can be perform... To mitigate against the emergence of resistance and improve patient care, the World Health Organization (WHO) recommends parasitological confirmation by microscopy or Rapid Diagnostic Tests (RDTs) before treatment. The emergence and rapid spread of parasite resistance to affordable, easy to use and widely available anti-malarial drugs such as chloroquine and sulfadoxine-pyrimethamine (SP) has prompted many countries in endemic areas to switch to the more effective artemisinin-based combination therapies (ACTs). Like other biological tests, malaria RDT is prone to deterioration through exposure to heat and humidity, and through manufacturing faults. SEOUL, South Korea, Sept. 9, 2024 /CNW/ -- Seegene Inc., a leading provider of total solution for PCR molecular diagnostics based in South Korea, announced today that it will introduce a new type of research-use-only (RUO) PCR assay to address the spread of the mpox virus variant, Clade Ib, which is currently prevalent in Africa. Furthermore, considering that this study included symptomatic subjects with and without mpox, our findings demonstrate a real-world diagnostic application of these assays . In order to evaluate the diagnostic application of these above-described RUO assays for mpox diagnosis, 27 positive and 10 negative human skin lesions were examined. Here, we evaluated the diagnostic performance of four real-time qualitative PCR assays for the laboratory diagnosis of mpox (monkeypox) monkeypox disease. Reduce the time taken to produce and edit business documents, ensuring reliability of numbering, styles and formatting. Both assays feature dual internal controls (Endogenous Internal Control, Exogenous Internal Control) within the same tube. NovaplexTM HSV-1&2/VZV/MPXV Assay (RUO) is designed to detect Clade 1 and Clade 2 of the mpox virus, while also distinguishing between Clade 2 of the mpox virus. NovaplexTM MPXV/OPXV Assay (RUO) is designed to detect pathogens caused by Orthopox-viruses, including Clades 1 and 2 of the mpox virus. "We will closely collaborate with governments around the world that need assays and plan to supply them with products meeting the needs of their respective markets." said Daniel Shin, Executive Vice-President and Chief Global Sales and Marketing Officer at Seegene. Seegene previously developed Novaplex MPXV (RUO) in 2022 using its advanced Seegene Digitalized Development System (SGDDS), which was developed based on Seegene's expertise to rapidly create and deploy new assays.A generalized linear mixed model was applied to investigate the association between the assay and cycle threshold (Ct) values.The Novaplex SARS-CoV-2 Variants VII Assay (Novaplex) (Seegene, Seoul, Republic of Korea) was carried out according to the manufacturer’s instructions using the CFX96 Real Time PCR Detection System and the BioRad CFX96 Manager software (Bio-Rad, Hercules, CA, USA).A critical aspect in the fight against malaria is accurate diagnosis followed by timely treatment with effective antimalarial drugs .This evaluation compared Seegene Technologies Novaplex SARS-CoV-2 Variants I, II, and IV (I,II&IV) assays to detect known SARS-CoV-2 variants using traditional spike gene Sanger sequencing results as the gold standard reference.The failure of microscopy to detect such a substantial proportion of positive infections alludes to submicroscopic parasitemia most probably due to low parasite densities and/or operational shortcomings by the laboratory technicians.Because of the increase in SARS-CoV-2 variants globally, and the resulting decrease in vaccine efficacy for some,1 it may be necessary to reformulate vaccines in the future. An additional advantage of this commercial kit is that it can be used with conventional real-time thermal cyclers. This variant has been named R.1 and categorized as a VOI in Japan as of April 7, 2021; however, this variant could bypass the screening stage in our country. This limitation can be overcome by the Novaplex™ SARS-CoV-2 Variants I Assay kit that can substantially shorten the turnaround time. The test results were automatically displayed on the monitor via the software's interface (Seegene Viewer). PCR mixture was prepared using the extracted RNA and Novaplex™ SARS-CoV-2 Variants I Assay kit reagents; real-time reverse transcription-PCR was performed using the CFX96 Touch Real-Time PCR Detection System. There are growing calls to ensure access to medicines for developing countries as mpox, once an endemic disease in Africa, poses a global threat. The results show that Novaplex is a suitable method for detection of HPV in FFPE tissues. The rate of inadequate samples was low in both approaches (reference, 3.4%; Novaplex, 1.7%). Several RT-PCR assays for VOC identification rely on the detection of specific SNPs 27,28,29, but few data are available regarding their ability to recognize SARS-CoV-2 variants in samples that are classed as undetermined with different assays. This comparative evaluation of the Seegene Technologies Novaplex I, II, & IV assays demonstrated excellent analytical sensitivity and specificity for the detection and differentiation of known SARS-CoV-2 variants when compared with S gene sequencing. In this study, Seegene Technologies Novaplex SARS-CoV-2 Variants I, II, and IV (I,II&IV) assays (Seegene Technologies, Walnut Creek, CA) were compared with S gene sequencing for the detection of known SARS-CoV-2 variants. In the current study, the results show that the routine diagnostic tools used for malaria detection have a lower sensitivity (63.7% and 61.5%, for microscopy and RDT respectively) compared to the WHO recommendation of at least 95% for an effective diagnostic tool . We describe here, for the first time, a national scale methodical evaluation of 2 such MPXV PCR commercial kits. However, due to the fact that the disease was geographically limited until the present outbreak, availability of commercial MPXV detection kits was very limited, until recently. Although serological MPOX-specific tests were reported (5), they could not be readily implemented in most of the relevant diagnostic laboratories. The global smallpox vaccination campaign MPOX rendered serological diagnostics very challenging (5). On the contrary, the Cq values of the Novaplex kit were significantly higher than those of the in-house assay, with differences of 3 to 5 cycles per sample. Type-specific concordance and sample concordance between reference assays and Novaplex were determined for four groups (HPV 16/18, 9v, 14HR and 21HPV). A positive for internal control was required to report HPV negative results and samples negative for both HPV and internal controls were designated inadequate. The Novaplex (Seegene Technologies, Walnut Creek, California) is a multiplex fluorescent-based PCR assay that allows for simultaneous amplification, detection, and differentiation of 28 HPV types (HPV6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 66, 68, 69, 70, 73, and 82). The typing results from reference assay (LA with reflex to LiPA) were interpretated using LA & LiPA Testing Algorithm shown in Table S1. Seegene's development of assays aims to curb the global outbreak of mpox and advance its vision of a "world free from all diseases." However, few typing assays have been validated for testing FFPE samples. In fact, in our context, 20% of samples classed as negative or undetermined with TaqPath, among them being twelve not typed via SaS, were instead typed via Novaplex, thus highlighting the higher sensitivity of this method based on SNP multiplex real-time RT-PCR. For HEV/HRV detection, the best performance was achieved by the Allplex RP 2 and 3 (35.3%) compared to the BioFire FilmArray RP assay (21.5%).We thank Seegene Technologies for providing Novaplex SARS-CoV-2 Variants I, II, and IV assay kits used in this study.Taken together, a commercial SARS-CoV-2 variant genotyping assay detected the rapid rate at which the Delta variant displaced the Beta variant in Limpopo, an under-monitored province in South Africa.A total of 622 samples were tested using both methods.Viral load is semi-quantified in Anyplex as high (+++; positive signal before 31 PCR cycles), medium (++; positive signal between 31 and 39 PCR cycles), or low (+; positive signal after 40 PCR cycles), and has an endogen internal control. For a law firm like Devonshires, transitioning to new software is a complex undertaking. The solution must be intelligent enough to understand how each document should be treated based on the document lifecycle. Having used their software for several years, Lubbock Fine turned to Novaplex to assist with the challenges of the iManage upgrade and LLP conversion. During the kit evaluation trial, the panel samples were randomly labeled 1 to 10, without any indication of the expected result. The standard sample panel was tested 6 times on different days, and the average (mean) values and standard deviation obtained are detailed in Table 1. The analytic limit of detection that was accomplished in all repeats (100%), was 2 to 8 copies/μL for both MPXV reactions (Fig. S2). The sensitivity and the specificity of the “general” (GE) and clade 2 (formerly “West African” clade and referred to as WA hereafter) reactions were previously determined by Li et al. (2010) (7). This assay provides reliable test results with broad coverage, detecting type 1 and type 2 of herpes simplex virus (HSV), as well as varicella-zoster virus (VZV) that exhibit symptoms similar to the mpox virus using the multiplex PCR testing. Our study, carried out on samples tested with TaqPath, demonstrated the high capability of SNP-based assays to detect VOCs. These findings suggest that Novaplex and Allplex are effective diagnostic systems for identifying Omicron BA.1 and BA.2 and Delta variants using multiplex real-time RT-PCR without sequencing. 21HPV, 21 HPV types (HPV6, 11, 16, 18, 31, 33, 35, 39, 40, 42, 45, 51, 52, 53, 54, 56, 58, 59, 66, 68, 70) targeted by Novaplex and reference assays The positive concordance values ranged from 77.0% to 84.0% and were comparable among all four HPV groups analyzed in this study. The type-specific concordance between the Novaplex and reference assays, shown in Table 2, indicates excellent agreement, Cohen’s kappa for all three HPV comparison groups ranged from 0.86 to 0.89. 9v corresponds to 9 HPV types (HPV6, 11, 16, 18, 31, 33, 45, 52, and 58) targeted by the Gardasil 9 HPV vaccine, 14HR corresponds to 14 high-risk HPV types (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), and 21HPV denotes 21 HPV types (HPV6, 11, 16, 18, 31, 33, 35, 39, 40, 42, 45, 51, 52, 53, 54, 56, 58, 59, 66, 68, and 70) common among LA, LiPA and Novaplex assays. At the beginning of the study, the Delta VOC was prevalent, but the Omicron sublineage BA.1 variant became dominant in January 2021, followed by the emergence of the Omicron 2 variant thereafter. SARS-CoV2 S gene and SNP detected via Novaplex and Allplex assays. Samples showing ∆69/70 deletion (Δ69/70) and N501Y were considered positive for the Alpha variant. The set of primers can detect three SARS-CoV-2 variants of the S gene showing ∆69/70, E484A, and N501Y (Figure 1). Finally, underpinning the above elements, is the need for the law firm to access specialists in the area of document templates throughout the lifecycle of their solution to ensure that it remains optimal at all times. The assay provides a quicker, species-specific diagnosis with a high positive predictive value of 99.2%, addressing the inadequacies of microscopy and RDTs that often yield low NPVs. The software enables vital advance detection of possible pump failure, allowing planned maintenance to be scheduled and resulting in optimised uptime and protecting production capacity. The Novaplex™ SARS-CoV-2 Variants VII assay addresses Omicron and its stealth version, as well as other variants. Differently from other kits, the M10 assay is performed on a fully automated STANDARD M10 point-of-care platform, being an all-in-one cartridge-based RT2-PCR that integrates all steps in a closed system. For instance, while the RealStar kit detects only DENV, while the other four kits target also Zika (Clonit’ngo, BioPerfectus, Novaplex and M10), Chikungunya (Clonit’ngo, BioPerfectus, Novaplex and M10), West Nile (Novaplex and M10) and Yellow Fever (M10) viruses. DENV-1 RNA preparations were made by the Italian Institute of Health within a national quality control program for DENV diagnostics. RNA extraction and a confirmatory SARS-CoV-2 RT-PCR was performed on samples prior to variant typing. For samples with only two genes positive with Ct values below 35, the average of the two genes was used as the median. Asterisks indicate variants for which the indicated mutation is not present in all sub-lineages. In South Africa, the Network for Genomics Surveillance (NGS-SA) led the country’s variant monitoring efforts using whole genome sequencing based approaches to identify the Beta, Delta and Omicron variants early 12–15. Since 2010,World Health Organization (WHO) recommended that malaria case management be based on parasite diagnosis in all cases (Cunningham et al., 2019). It is the highest contributor to morbidity and mortality in developing countries, in Kenya, there are an estimated 3.5 million new clinical cases and 10,700 deaths each year, and those living in western Kenya especially have high risk of malaria (Kishoyian et al., 2021). The malaria RDTs were also compared to PCR which is a more sensitive reference test. Sensitivity, specificity, positive predictive value PPV, negative predictive value NPV, accuracy, and agreement Cohen’s kappa were calc... Comparison of Allplex RP 1, 2, 3 and BioFire FilmArray RP assays for the detection of respiratory viruses in NPS specimens. The diagnostic performance of Allplex RP 1, 2, 3, and the BioFire FilmArray RP assays for detecting respiratory viruses in NPS specimens are summarized in Table 1. The diagnostic performance of the RP assays was evaluated based on positive and negative agreement. With integrated nucleic acid extraction, nested multiplex PCR amplification, detection, automated data analysis, and interpretation of results as detected or not detected, the BioFire RP assay requires a run time of approximately 45 min. Once a new variant of concern is detected, it is important to track its spread in real-time and monitor recent genomic changes as part of public health surveillance. Template Studio's cross-referencing tool significantly reduces the time spent reviewing and managing documents. Transform is a software product that fixes formatting and numbering issues in Microsoft Word documents. The mpox variant is now spreading beyond African countries including Sweden, Pakistan, the Philippines, Jordan and Thailand. Among these, Novaplex™ MPXV/OPXV Assay (RUO) is designed to detect MPXV Clade I and Clade II as well as OPXV infections, while Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO) is designed to simultaneously detect four viruses including MPXV, herpes simplex virus (HSV) Types 1 and 2, and varicella-zoster virus (VZV). Published in The Journal of molecular diagnostics : JMD - 01 May 2022 The false negatives for microscopy and RDT were 49 and 52 which is highly contrasted to only 6 false negatives when the Novaplex® assay was used. This is highly comparable to 135 positive samples which were detected by qPCR. The percentage of every species was calculated in relation to the total positive samples in each case at a 95% Confidence Interval. Results of the diagnosis by microscopy, q-PCR, and Novaplex™ assay. Comparison of Ct values of E484A, N501Y, and RdRp for samples that were undetermined or negative with TaqPath and typed using Novaplex. To determine if Delta samples were correctly identified as Delta lineages via SaS, the samples were tested with Allplex, providing further confirmation of these data. Later, with the emergence of the Omicron sublineage BA.2 (characterized by the absence of the Δ69–70 mutation) and the progressive disappearance of Delta variant circulation, the SGTF result was applied to distinguish between Omicron BA.1 and BA.2 lineages (Figure 2) . The GraphPad v9.0 software (GraphPad, San Diego, CA, USA) was used for the statistical analysis. Results were analyzed using a dedicated software program, BioRad CFX96 Manager (Bio-Rad, Hercules, CA, USA), which indicates the Ct value for each specific mutation probe. Procedure for real-time reverse transcription-PCR using the commercial Seegene kit and system. Procedure for real-time reverse transcription-PCR… The variant with E484K substitution alone ("R.1") has been now categorized as a variant of interest in Japan. A total of 14 more samples were found positive for M. The TMA-positive samples were further analyzed according to their anatomical site. Table 2 and S1 Table show the diagnostic performance of the systems used for detection of the different pathogens. This system is a fully automated testing platform with true sample-to-result automation allowing sample testing with Aptima® assays, therefore avoiding the separate DNA extraction step. Table 3. Compare by Novaplex enables firms to meet industry and regulatory compliance requirements by providing a reliable tool for discovering, tracking, and reporting the differences in content between documents. The study protocol was approved by the SERU at Kenya Medical Research Institute study approval number KEMRI/CBRD/235/SERU4522. Patients were enrolled in the study according to the KEMRI-SERU (Scientific Ethics Review Unit) procedures which follow the Helsinki declaration and the ICH-GCP guidelines. Many thanks to the patients, the children and their guardians, for their participation in this study. Creating company branded documents offline This complete concordance is most likely due to a smaller number of positive samples (1.1%), and the study period was during the non-influenza epidemic (October and November). It was not possible to compare the performance of the Allplex RP 1 and 2 against the BioFire FilmArray RP assays for human coronavirus, FluB, and MPV, as these analytes were not detected in any NPS specimens tested. This is crucial for the detection of ARIs because the pathogens can be present at low levels in clinical samples, and their abundance quickly drops over time despite symptoms being present . Cycle threshold (Ct) values of viruses detected in NPS specimens by the Allplex RP 1, 2, 3 assays. In addition to the consistent shift in Cq values, the relative fluorescence (RFU values) varied significantly, between the in-house and Bio-Speedy assays, and the Novaplex assay, where the RFU values were between 10 and 20-fold lower. These differences suggest that direct comparison between results of different assays cannot be performed and the “Cq shift” should be taken into consideration when analyzing results obtained with different assays. Our study focused on evaluating the performance of the 2 kits by simultaneous testing in different laboratories, but also on comparing the commercial kits and the CVL in-house assay. The in-house assay had an analytical detection limit of less than 10 copies per reaction. Comparison of the results showed high intra-assay agreement between laboratories, with small variations for most samples. The objective of this study was to evaluate 2 kits by different diagnostic laboratories across Israel. The Seegene software (version 1.0) enables the identification and differentiation of multiple targets in a single channel. In addition, differences in the I,II&IV assay results using either standard chloroform-ethanol extracted RNA or extraction-free, heat-released RNA, were investigated. Firms are looking for software to help ease the burden on limited resources to be more efficient.