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IOL News
23-05-2025
- Health
- IOL News
Sahpra approves first mpox diagnostic test to enhance global health efforts
South Africa has approved the first mpox diagnostic test, bolstering efforts to improve testing access across the globe. Image: Se-Anne Rall/IOL The South African Health Products Regulatory Authority (Sahpra) has made significant strides in combating mpox (formerly known as monkeypox) by approving the Alinity m MPX assay as the first in vitro diagnostic (IVD) test for the virus. This approval, facilitated through reliance on the World Health Organization's (WHO) Prequalification (PQ) assessment and Emergency Use Listing (EUL), marks a pivotal moment in enhancing global access to mpox testing. According to Dr Boitumelo Semete-Makokotlela, Sahpra's Chief Executive Officer, the timely listing of this diagnostic assay is a considerable milestone in efforts to leverage regulatory reliance mechanisms for improved health outcomes. 'For Sahpra to have been able to list this assay timeously, post a WHO PQ EUL, this marks a significant milestone in aiding global access to mpox testing by leveraging regulatory reliance mechanisms,' she stated. In the backdrop of ongoing mpox outbreaks, the emergency use approval of the Alinity m MPX assay, developed by Abbott Molecular Inc. and licensed to Abbott Laboratories South Africa (Pty) Ltd, is paramount. The nature of mpox necessitates rapid and accurate testing for early detection, timely treatment, and overall effective containment of the virus. Currently, only nasopharyngeal RT-PCR (reverse transcription polymerase chain reaction) tests are under consideration by SAHPRA for mpox diagnostics. Video Player is loading. Play Video Play Unmute Current Time 0:00 / Duration -:- Loaded : 0% Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Background Color Black White Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Transparent Window Color Black White Red Green Blue Yellow Magenta Cyan Transparency Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Dropshadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. Advertisement Next Stay Close ✕ Healthcare agencies, including the African Centres for Disease Control and Prevention (Africa CDC) and WHO, have emphasised that there is a lack of independently validated antigen rapid diagnostic tests (RDTs) in the market with a clinical sensitivity of at least 80% for mpox testing. As a result, antigen and antibody rapid test kits, including self-test versions, are not recommended at this time. The regulatory requirements for mpox diagnostics can be found in a detailed communication to industry stakeholders, specifically under Issue No.: MD01-2024/25 v1. The document is readily available on Sahpra's official website, which provides guidance on further WHO recommendations regarding mpox diagnostics. IOL
Yahoo
19-02-2025
- Health
- Yahoo
Mass polio vaccination campaign to continue in Gaza after virus detected in wastewater samples
A mass polio vaccination campaign is set to continue in Gaza after the virus was recently detected in wastewater samples. The campaign aims to vaccinate more than 591,000 children in Gaza under 10 years old between Saturday and Feb. 26, the World Health Organization announced. Efforts will be led by the Palestinian Ministry of Health and will be supported by the WHO, United Nations Children's Fund (UNICEF), United Nations Relief and Works Agency for Palestine Refugees in the Near East (UNRWA) and other partners, the global health agency said Wednesday. Polio vaccinations wrap up in Gaza as officials try to inoculate 90% of children under age 10 Children are receiving two drops of novel oral polio vaccine type 2 (nOPV2), which has been used for outbreak response under the WHO's Emergency Use Listing Procedure (EUL) approval since March 2021. A second dose is typically given four weeks after the first. The WHO coordinated two previous mass vaccination rounds in September and October 2024, saying it reached 95% of its target population in Gaza. The current campaign will aim to reach all children under age 10, including those previously missed to help close any immunity gaps, the WHO said. At least 7,000 children were missed during the second vaccination round in October due to hostilities in the Israel-Hamas war and areas where humanitarian pauses for vaccination were not guaranteed, the WHO said. "As poliovirus is found to remain in the environment, additional vaccination efforts are needed to reach every child and strengthen population immunity," the WHO said in a press release. "The presence of the virus still poses a risk to children with low or no immunity, in Gaza and throughout the region." The WHO and its partners also plan to carry out another mass polio vaccination in April of this year, the agency said. In mid-August 2024, the Palestinian Ministry of Health reported the first case of polio in 25 years in a 10-month-old child who had not been vaccinated and became paralyzed, according to the WHO. Doctors suspected polio after symptoms resembled the virus, which was confirmed in tests conducted in Amman, the capital of Jordan, the agency said. Public health experts previously told ABC News they believe the true number of polio cases may have been higher, with many cases having gone undetected. Although no additional cases have been reported, wastewater samples collected in Deir al Balah in central Gaza and Khan Younis in southern Gaza in December 2024 and January, respectively, confirm polio transmission, according to the WHO. MORE: What to know about the polio vaccine and why most people aren't at risk of infection The polio strain detected in the recent wastewater samples is genetically linked to the sample first detected in Gaza in July 2024. The WHO estimates that in 2022, polio vaccination coverage, conducted through routine immunization, was at 99%. However, since the outbreak of the war following Hamas' terror attack on Israel on Oct. 7, 2023, this percentage has fallen. According to the latest WHO-UNICEF routine immunization report, the number is estimated to be at 89% in 2023 due to the number of newborns not vaccinated. Polio largely affects children under age 5 and can lead to paralysis or death. There are about 341,000 children under the age of five in Gaza, according to the Palestinian Central Bureau of Statistics. Mass polio vaccination campaign to continue in Gaza after virus detected in wastewater samples originally appeared on
