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FIND and Unitaid invest to support technology transfer and boost local production of COVID-19 Rapid
GENEVA, SWITZERLAND – 15 July 2021. Local manufacturing of COVID-19 rapid tests in Africa and Latin America will be dramatically expanded, thanks to investment from FIND, the global alliance for diagnostics, and Unitaid. Following a call for Expressions of Interest launched under the Access to COVID-19 Tools (ACT)-Accelerator Diagnostics Pillar, contracts have now been finalized to drive equitable access to fit-for-purpose antigen rapid diagnostic tests (Ag RDTs) for COVID-19. The pandemic has exposed how fragile health structures and an exclusive reliance on global supply chains leave many countries without access to the tests they need to control COVID-19. Today, high-income countries are testing people for COVID-19 over 60 times more than low-income countries. Expanded production capacity in local and regional hubs is critical to ensuring that healthcare providers in low- and middle-income countries (LMICs) can implement effective testing strategies to contain the spread of the virus. Agreements have been signed to support collaborations between Xixia Pharmaceuticals (a subsidiary of Viatris) and Guangzhou Wondfo Biotech (Wondfo), DCN Dx and WAMA Diagnóstica, and DIATROPIX of the Institut Pasteur de Dakar, Bionote and Mologic. FIND and Unitaid are supporting the creation of a Centre of Excellence at DCN Dx to facilitate RDT technology transfer to LMIC manufacturers. WAMA Diagnóstica, based in Brazil, is the first of these, and will supply the Latin America and Caribbean region. Test volumes are expected to reach 2 million tests per month, with a ceiling price of US$2.00 (ex-works). To serve the African continent, DIATROPIX of the Institut Pasteur de Dakar in Senegal is being supported to scale up manufacturing of Ag RDTs transferred from Mologic and Bionote. Through this support, diaTROPIX will seek regulatory authorization for the transferred tests and commercialize them under its own brand, with the aim of reaching 2.5 million tests per month by 2022, at prices ranging from US$2.50 to US$2.00 (ex-works) with a view to further reductions in the near future. In a further boost to testing capacity in LMICs, FIND and Unitaid announce that Wondfo, based in Guangzhou, China, is teaming up with Viatris (operating through its subsidiary Xixia Pharmaceuticals based in Gauteng, South Africa) to bring its low-cost Ag RDTs to market in LMICs. This partnership between a high-volume manufacturer and a distributor with global reach has the potential to produce 144 million tests per year, at a ceiling price of US$2.50 (ex-works). Recently released WHO guidance on national SARS-CoV-2 testing strategies emphasises the important role of high-quality Ag RDTs. They remain the primary diagnostic test for detection of active SARS-CoV-2 infection in decentralized settings where timely molecular testing is not available. Marta Fernández Suárez, Senior Director of R&D at FIND, said: “Scaling up testing capacity in LMICs is one of our highest priorities. The EOI process has enabled us to identify partnerships that we believe can have a great impact in key regions that are of critical importance to the pandemic and potentially beyond, to help ensure that everyone who needs a test can get one.” Vincent Bretin, Director of Results at Unitaid, said: “Increasing the capacity of local and regional hubs to produce COVID-19 tests will be vital if we are to ensure truly equitable access to this crucial tool. Currently the vast majority of rapid tests being used in low- and middle-income countries are manufactured in just two countries in one region, so these agreements are an important step in ensuring that countries are equipped to detect cases of COVID-19, helping contain outbreaks and bringing a swifter end to the pandemic.” Announcement of these agreements follows a technical workshop on local production of diagnostics in LMICs, hosted by the World Health Organization, UNDP and FIND, to contribute to the ongoing development of comprehensive and practical measures to catalyse and sustain production of diagnostics in these countries. More details and a recording of the meeting are available here. Original News Link: https://www.finddx.org/newsroom/pr-15jul21/
- 2021.07.19
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Clinical utility of Vcheck CRP in canine filariasis (International journal)
A paper on the clinical usefulness of Vcheck CRP in dogs infected with heartworms has been published in the international journal, Veterinary world (IF 2.11). See the attached file for full paper. Canine filariasis is a prominent mosquito-borne disease which is caused by several species of filarial worms, including Dirofilaria immitis. The pathophysiological response to infection is mainly due to the filaria lifecycle. In this study, blood samples were collected from 980 dogs who have visited animal hospitals and all samples were tested to determine the presence of microfilaria. In positive samples, the serum protein profiles and CRP concentrations using the Vcheck CRP 2.0 were examined. The average CRP concentrations of dogs infected with only D. immitis was 69.6 (13.6-116.9) mg/L. A dog infected with both D. immitis and B. pahangi had very high CRP concentrations (>200 mg/L). The total protein, β2 globulin, and γ globulin levels increased, while albumin levels and albumin-to-globulin (A/G) ratios were significantly reduced. In heartworm disease, adult worms are localized in the pulmonary arteries, which induces endothelial damage or proliferative endocarditis. Chronic inflammation leads to elevated CRP concentrations and hyperglobulinemia. According to this study, the serum protein profiles and CRP concentrations in canine filariasis can reflect the health status of infected dogs. In particular, the CRP concentrations in dogs infected with D. immitis were significantly high, proving its usefulness as a marker of inflammation. C-reactive protein (CRP), a major acute protein in dogs, is elevated in response to inflammatory stimuli, which can be useful in various inflammatory situations such as infections, tumors, acute pancreatitis, and surgery. Vcheck CRP 2.0 can be quantitatively measured using a fluorescent immunoassay analyzer, Vcheck, and can be tested using a small amount of sample (a serum or plasma 5ul). It also has a wide measurement range of 10 to 200 mg/L, making it suitable for monitoring responses during treatment. Learn more
- 2021.07.14
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High immunogenicity following WSAVA guidelines, confirmed by VcheckA paper using Vcheck CPV Ab testing has been published with results proving that regular vaccinations under the WSAVA guidelines increase the protection rate against parvovirus. - [Related document] Evaluation materials Canine parvovirosis is a systemic disease caused by CPV-2 (canine parvovirus type 2). Typical symptoms of parvovirus include lack of appetite, vomiting, and bloody diarrhea.The most effective way to prevent the parvovirus is prophylactic vaccination, and according to the WSAVA guidelines, it is recommended that booster vaccines be performed not more often than every 3 years after the initial puppy vaccination. Based on the history of the vaccination against CPV, the study population was divided into three groups: - Group I (n=59): Dogs regularly vaccinated against the disease according to WSAVA guidelines- Group II (n=77): Dogs that completed the full course of CPV immunization as puppies but have not received a booster dose in the past three years- Group III (n=64): Dogs that have not received vaccination against parvovirus in their lifetime Statistical analysis showed a significantly greater number of dogs with high titers of antibodies against CPV of HI ≥ 80 in Group I (86%) compared to Group II (73%), and Group III (72%). Table 1. Values of antibody titers in HI test for CPV in dogs in each group Gender and race were not found to have an influence over the value of antibody titers against CPV. Regular vaccinations by WSAVA recommendations increase protection against CPV, as evidenced by the lowest percentage of dogs with HI < 80 in Group I, which were regularly vaccinated at least every 3 years. Additionally, the presence of dogs with high antibody titers against CPV in Group III indicates widespread contamination of the pathogen within the environment. Bionote's immunofluorescence analyzer, Vcheck, is designed to generate fast and accurate diagnoses for in-clinic testing through its automative blood testing system that can run 24 quantitative and semi-qualitative tests (NT-proBNP, SDMA, D-dimer, CRP, SAA, cPL, fPL, cCortisol, T4, TSH, Progesterone, and Antibody titers).
- 2021.03.24
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