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
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
IOL News
a day ago
- IOL News
South Africa rolls out emergency measures to contain foot-and-mouth disease
The government is preparing to issue new directives aimed at controlling the movement of cloven-hoofed livestock across the country Image: Ayanda Ndamane Independent Newspapers The government is preparing to issue new directives aimed at controlling the movement of cloven-hoofed livestock across the country, in response to the recent foot and mouth disease (FMD) outbreak. South Africa has been battling FMD for several months, prompting key trading partners including Zimbabwe, Namibia, Botswana, and China to suspend imports of meat and related animal products from the country. Earlier this week, one of the major feedlot groups in South Africa, Karan Beef, confirmed a case of FMD at its feedlot in Heidelberg, Gauteng, prompting a temporary halt on purchases. IOL previously reported Minister of Agriculture, John Steenhuisen, announced that the government has placed an urgent order for R72 million worth of foot-and-mouth disease (FMD) vaccines to fight the disease with the vaccine set to arrive in the country by the second week of June. I can announce, regarding the Foot-and-Mouth disease outbreak, that the Department of Agriculture has ordered vaccines to cover the KwaZulu Natal area, while assessment, as well forward and backward tracing of the outbreak in Gauteng is ongoing. — John Steenhuisen MP (@jsteenhuisen) June 5, 2025 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 ✕ According to reports, the upcoming directives will require all livestock movements to be supervised and to comply strictly with biosecurity measures. Only animals meeting these standards will be permitted to move, in a bid to contain the spread of the disease. These measures are expected to be officially gazetted soon, giving them legal force and reinforcing efforts to protect both commercial and small-scale farmers. "Foot and Mouth has been with us since 2016 and we've seen provinces come in and out of foot and mouth status. It all comes down to adhering to the biosecurity regulations that govern the movement of animals and the auctioning of animals. "It again stresses why we need a track and trace system in South Africa to govern that but we have also put aside R72 million. We've procured vaccines from the Botswana Vaccine Institute." Steenhuisen. The minister underscored the importance of multi-agency cooperation in enforcing the regulations. "We will need cooperation from other departments, Saps need to help us with the movement of vehicles, national traffic, municipal traffic and the border management agency. "All need to assist us in ensuring that we stop the unlawful movement of animals because that's how it spreads. I have now published a set of stringent regulations it's being gazetted in the next few days and we will take strong actions against those who break the law," he added. Wandile Sihlobo, Chief Economist at the Agricultural Business Chamber of South Africa (Agbiz), emphasised the growing urgency of investment in biosecurity, noting a rise in disease outbreaks across the country.
IOL News
2 days ago
- IOL News
Nearly one in five South Africans lack access to safe sanitation, KwaZulu-Natal households still struggle to fetch water
More than one-third (35,8%) of households in KwaZulu-Natal without piped water in their dwellings or on site took more than 30 minutes to fetch water. Image: Oupa Mokoena Independent Newspapers KwaZulu-Natal continues to face significant challenges in providing basic water and sanitation services to its residents, with new data revealing that many households still spend over 30 minutes fetching drinking water. In addition, nearly one in five South Africans still share sanitation facilities. This is according to the 2024 General Household Survey (GHS) released by Statistics South Africa. The survey found that 35.8% of households in KZN without piped water in their dwellings or on site took more than 30 minutes to fetch water, highlighting ongoing difficulties with access in the province. While 83.3% of households in KZN had access to at least a basic level of drinking water, this is still lower than national leaders such as the Western Cape (99.8%) and Gauteng (99.6%). The GHS also showed that provinces like KZN, Limpopo (86.4%) and the Eastern Cape (87.8%) recorded the highest reliance on surface water, a key indicator of limited or unsafe access. The report distinguishes between levels of water access using what the WHO/UNICEF Joint Monitoring Programme (JMP) calls the 'water ladder.' The highest level is 'safely managed' water available on premises, when needed, and free of harmful contamination. Basic water requires a collection time of less than 30 minutes; anything longer is considered 'limited.' Nationally, more than two-thirds (67.8%) of households that fetch their water do so in under 30 minutes, but 5% spend over an hour, underscoring the severity of the issue in specific communities, especially in rural areas. The situation is further complicated by sanitation challenges. The survey shows that only 76.3% of South Africans had access to safely managed sanitation services in 2024, those that are improved, not shared, and where waste is treated. Despite being a more urbanised province, Gauteng had the lowest access to safely managed sanitation at 66.1%, while the Eastern Cape (85.3%), Mpumalanga (84.7%), and the Northern Cape (84.4%) topped the list. Nationally, 19.9% of South Africans shared sanitation facilities, but this figure was much higher in urban areas (31.9%) compared to rural areas (13.2%). Urban informal settlements often lack the infrastructure for private toilets, and multiple households are forced to share, creating hygiene and dignity concerns. Interestingly, rural areas surpassed urban areas in access to safely managed sanitation, with 79.6% compared to 74.6%, largely due to space availability for household-level improved facilities, even if they are basic. The GHS explains that, under Sustainable Development Goal 6.2, a sanitation service is only considered safely managed if it is improved, not shared, and waste is properly treated, either on-site, via off-site treatment after collection, or through a sewer system. Only 46.2% of households nationally had sanitation facilities inside their homes, while 3.1% relied on facilities outside their yards. These figures reflect the ongoing infrastructure gaps, particularly in under-resourced or overcrowded areas. THE MERCURY
IOL News
3 days ago
- IOL News
Call for vetting of pastors, healers as ritual crimes against children shock SA
IOL spent time with chairperson of the Commission for the Promotion of the Rights of Cultural, Religious and Linguistic Communities (CRL Rights Commission), Thoko Mkhwanazi-Xaluva at her offices in Braamfontein, Johannesburg. Image: Jonisayi Maromo/IOL South African communities have experienced various heinous crimes committed by perpetrators, including leaders of faith-based organisations—particularly sangomas and pastors. Earlier this week, IOL reported that a 50-year-old sangoma, Sebokoana Khounyana, appeared before the Vanderbijlpark Magistrate's Court in Gauteng facing charges of premeditated murder and human trafficking of two-year-old baby, Kutlwano Shalaba. Gauteng spokesperson for the National Prosecuting Authority (NPA) Lumka Mahanjana said a charge of premeditated murder was also added against the baby's mother Kuneuwe Portia Shalaba. Kutlwano Shalaba was murdered allegedly by her mother and a sangoma. Image: Facebook 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 ✕ Ad Loading The 32-year-old mother was previously facing charges of human trafficking, conspiracy to commit robbery and making a false statement to the police. On Wednesday morning, IOL reported that the specialised occult unit of the South African Police Service (SAPS) has been roped in to probe the brutal murder of Roodepoort teenager Likhona Fose, whose mutilated body was discovered on Sunday. The 14-year-old Grade 8 learner at Ikusasalethu Secondary School in Braamfischerville, Joburg apparently lived with her grandmother, who could not find her on Saturday. Her butchered body was found in an open field, covered with vegetation around Durban Deep, in Roodepoort, Gauteng. Deputy Minister of Police Dr Polly Boshielo has confirmed that the genitalia of a young girl was removed by her killers. As crime experts suggest the possibility of an occult-related murder in the case of Likhona, IOL spoke with Thoko Mkhwanazi-Xaluva, chairperson of the Commission for the Promotion of the Rights of Cultural, Religious and Linguistic Communities (CRL Rights Commission), at her offices in Braamfontein, Johannesburg. 'The issue of Child Protection Week is very critical in a country like ours. Our children are not safe—even in their homes, they are not safe. Even in their communities, they are not safe. We are one of those countries which are not fit for children,' she said. 'We are a country that, if we had choices, we wouldn't have children in this country. We are a country that does not pay as much attention as it should, where children are concerned.' 'On basic things like access to education, some children still walk long distances when the transport system fails. Some schools still do not have toilets. So, even before we get to the alarmingly high levels of child abuse in this country, there are already many things that need urgent attention,' said Thoko Mkhwanazi-Xaluva. She said Child Protection Week was an opportunity for South Africans to reflect on their individual contributions to creating safer environments for children. 'As the CRL Rights Commission, we asked: How can we use the Children's Act to protect children? How do we ensure that the Act is implemented? It's an established law that can protect children. We are looking at spaces of worship and sacred spaces,' she told IOL. 'The law says anyone working with children must be vetted—not just teachers.' She emphasised that the law requires anyone working with children to be vetted, yet many religious leaders operate closely with children in their ministries without undergoing the necessary checks. 'Part of what we're asking is: in the religious sector, who is vetting pastors? If I start a church, who vets me? I'll have access to children. Suddenly, I love Sunday School and I'm always with the kids - and parents are thrilled that this nice pastor enjoys spending time with them. But has he been vetted? 'To ensure that pastors, bishops, and archbishops are properly vetted, what systems should be in place?' she said. 'Paedophilia is not something that easily leaves your system. People who prey on children deliberately seek out spaces where they can access them. If I'm a religious leader, I have access. Yet, in this country, we worry about teachers - some of whom are vetted, others not - but we ignore these unregulated spaces.' Mkhwanazi-Xaluva emphasised that the CRL Rights Commission will be tabling the issue of vetting and monitoring of religious leaders across South Africa. 'We are looking at vetting of traditional healers, because they have access to children as well. We are looking at vetting of people who do virginity testing. It is amazing that we have people who are working in a very delicate space in our children's lives and no one is monitoring them,' she said. 'When you have people who say, I want to test children below 16, and I insist on doing that, but I have not been vetted, there is a crisis there, looming. We think it is only men who can do certain things. Anyone can do whatever. This is a gender-free kind of space.' She said South Africa needs to go back to basics in terms of protecting its children. Mkhwanazi-Xaluva emphasised that not anyone with money for a tent and chairs should be allowed to open a church in South Africa. Mkhwanazi-Xaluva said in order to protect children, a regulator should receive applications from religious leaders and do proper vetting including taking fingerprints and identity documents of the applicants. 'We are not talking about new laws. These are laws that exist, implement those laws and the laws that exist take us straight to the Children's Act. So traditional healers, virginity testers, pastors, religious leaders of all kinds whether it is Islam, Jewish, or whatever - who is vetting them? It is the responsibility of the state to protect people. We are saying the state must do its job and its job is to make sure we are all safe, even if we do not see danger, we must be protected,' she said. Earlier this week, IOL spoke to renowned criminologist, Prof Kholofelo Rakubu who is the Head of Department at Tshwane University of Technology's Department of Law, Safety and Security Management, regarding the graphic nature of crime in South Africa, which often targets children. 'There are signs of an occult crime, which the occult crime investigations unit looks for. When they arrive at the scene, there are projects which tell them that this is an occult case. A body part must be missing, a particular body part is taken by the perpetrators and normally the perpetrators are not seen. 'You have not heard of a situation where perpetrators of an occult crime were seen doing it, we hear about it afterwards. That is because they are very professional. They are rational thinkers, they take time to pounce on their unsuspecting victims,' she said. 'To lure them, they take the victims to a designated place, they just do not do the killing at a tavern. They can dump the body somewhere, where it was not killed.' Rakubu, however, warned that the crime of occultic killers might get confused with psychotic killers. 'Sometimes a mentally disturbed person would do the crime in the same manner. They can kill their girlfriend, cut the body into pieces and keep them in a freezer because they are hearing voices and having psychological issues.'
