Researchers at Indiana University School of Medicine have discovered new information about how a dangerous parasite takes control of a patient’s cells as it spreads throughout their body, an important finding that could help in the development of new drugs to treat this infection.

The UK, US and Canada say state-backed hackers tried to steal coronavirus vaccine research.

• Lung injuries caused by vaping was big news before the new coronavirus hit the headlines
• Vaping is still happening, but medical professionals may not currently be focused on vaping as a cause of lung damage
• Vaping should be avoided as it increases the risk for Covid-19 complications

Reports of serious, even deadly, vaping-linked lung injuries dominated the headlines late last year, then Covid-19 took over the news.

But those lung injuries haven’t gone away, and signs of e-cigarette or vaping product use-associated lung injury (EVALI) can look a lot like a Covid-19 infection, federal and state health officials warn.

Eight cases of EVALI were reported in California in April, during the early days of the Covid-19 pandemic, according to a new report from the California Department of Public Health and the US Centers for Disease Control and Prevention (CDC).

“Teens didn’t stop vaping because of Covid,” said Dr Jamie Garfield, a pulmonary care doctor in Philadelphia and volunteer spokeswoman for the American Lung Association. But doctors may not be looking for EVALI much anymore, she said. Garfield was not involved with the new study.

Life-threatening lung damage

“When the prevalence of any disease is really high, everything that quacks like a duck is a duck, and in March and April, everything that sort of looked like Covid was Covid. This is where history-taking becomes very important. You have to know if a kid is vaping and what they’re vaping,” Garfield explained.

EVALI symptoms include:

• Shortness of breath
• Fever and chills
• Cough
• Vomiting
• Diarrhoea
• Headache
• Dizziness
• Rapid heart rate and chest pain

The CDC stopped tracking EVALI in mid-February, because cases appeared to be waning after a September peak. As of 18 February, more than 2 800 people nationwide had been hospitalised with life-threatening lung damage tied to e-cigarette use, the CDC said. Sixty-eight died.

Research into these cases strongly suggests that an additive called vitamin E acetate, which is sometimes used in pot-laced vapes, triggers EVALI, the CDC said.

A recent US study estimated that one in 10 middle and high school kids had vaped within the past month. At some schools, e-cigarette use was as high as 60%, according to findings published online recently in the Journal of Adolescent Health.

According to the new CDC report, the eight California EVALI patients went to the hospital about four days after symptoms began. Their average age was 17. Six said they had vaped THC (the psychoactive ingredient in marijuana).

‘No one should be vaping’

Four of the teens needed intensive care and two needed mechanical ventilation to breathe. None tested positive for Covid-19, study author Dr Christina Armatas, of the California Department of Public Health, and her colleagues noted.

These were the first cases reported in California since February. The researchers said it wasn’t clear if EVALI cases had been missed in March. The findings were published on 26 June in the CDC’s Morbidity and Mortality Weekly Report.

Dr Len Horovitz, a pulmonologist at Lenox Hill Hospital in New York City, noted that people with EVALI could also have Covid-19. He said it’s not clear whether vaping increases susceptibility to the new coronavirus, but it definitely increases the risk for Covid-19 complications. No one should be vaping, he added.

“There’s never been a place for vaping. Just because it’s legal doesn’t mean it’s OK,” Horovitz said.

Garfield agreed. “Vaping is not a safe alternative to smoking. Anything you put into your lungs besides clear air can increase your risk of lung injury,” she said.

If you do vape, use only pre-packaged products and never anything that has been tampered with in any way, she advised. There are programmes to help you quit, Garfield added.

Finally, she said it’s important to see a doctor if you use e-cigarettes and develop symptoms like cough, shortness of breath or fever – and to be honest about your vaping so you can get the right diagnosis.

^{Image credit: iStock}

• If you’re feeling lonely and stressed during the coronavirus pandemic, you’re not alone
• Humans are hard-wired to want to be around other people
• However, being alone isn’t the problem; it’s feeling alone that gets to us

If you’ve been keeping a healthy distance from other people because of Covid-19, you probably feel smart. But if you’re also feeling lonely and stressed, it doesn’t mean anything is wrong. It could simply mean you’re human.

The need to be around people is hard-wired into our brains, researchers say. We crave company in the same way we hunger for food or thirst for water. When that craving isn’t satisfied, the long-term health consequences can be serious.

Luckily, the need for togetherness can be met even at a distance.

The idea that our brains drive us to be around one another has gained popularity in recent decades, said Louise Hawkley, senior research scientist at NORC at the University of Chicago.

‘We absolutely need other people’

We evolved to be around those we know and trust, she said. “Our security was in numbers. We had our safety by being around other people. We weren’t particularly fast runners. We couldn’t defy what nature threw at us just by speed. We had to be smart about it. Well, one of the smart things we did was we capitalised on each other’s brains. We worked together.”

As Lane Beckes, an associate professor in the department of psychology at Bradley University in Peoria, Illinois, put it: “We absolutely need other people.”

Brain studies have shown how deeply this need is woven into our biology. A study in the journal Science found subjects who were excluded from a virtual ball-tossing game had more activity in the part of the brain that processes physical pain. Recently, researchers published preliminary findings on the preprint server bioRxiv that suggest loneliness triggers chemical responses in the brain similar to what’s prompted by hunger.

Other research has shown serious long-term health consequences from chronic loneliness. “It turns out that being socially connected is associated with approximately a 50% reduction in the risk of early death,” Beckes said. “In effect, it’s similar to the reduction of risk that somebody with coronary heart disease has if they quit smoking.”

Level of connectedness

A 2016 study in the journal Heart linked loneliness and social isolation to a 32% increased risk of having a stroke or developing coronary artery disease.

Beckes was part of research published in the International Journal of Psychophysiology that showed how people facing a threat have lower stress responses when they’re physically touching their partners or close friends. But here’s an important point for those of us sitting home during the pandemic – it’s not the physical company of others that defines loneliness. What matters most is that you feel as if someone has your back.

“It’s not being alone,” Hawkley said. “It’s feeling alone” – a mismatch between what you want and what you need.

Not everybody needs the same level of connectedness, she said. “And it’s a good thing, because we need those brave souls who are willing to break away from the group and be the explorers, (who) break new ground, get out there and go where no one has gone before. But there’s always got to be this backstop, this return to the safe base that even the explorers need.”

That sense of having a base can come in many ways, even without face-to-face contact.

“A lot of people can even live alone and be perfectly fine in part because they do things like they talk to their friends on the phone, they have Zoom conversations, they feel like other people will come to their aid” if they need help, Beckes said.

Don’t ignore safety

But there are limits. There’s a reason those Zoom conferences feel awkward. Stress, he said, arises when our brains don’t know what’s happening next. Usually, we’re absorbing all sorts of cues from those around us to try to anticipate what’s going to happen. The absence of those nonverbal signals makes online connections more stressful.

Which is why he recommends trying to arrange in-person social contact with physical distancing – perhaps a small gathering of friends outside at a park with space between people.

Just don’t ignore safety to socialise. “The health effects of loneliness and social isolation probably pale in comparison to an acute outbreak of the Covid-19 virus,” Beckes said.

If in-person meetings aren’t feasible, improve digital get-togethers. Try playing games online.

“When they have a shared focus, players are thinking about something besides those missing cues,” he said. “Anything that sort of reduces the awkwardness and stress of interacting with other people is going to be more rewarding and, ultimately, a better source of satisfying your social need.”

Make a list of people to connect with

Hawkley said taking initiative is key. A review she helped conduct about anti-loneliness techniques that was published in the journal Personality and Social Psychology Review suggested the brains of lonely people get “hijacked” by negative thoughts.

She suggested making a list of people to connect with, perhaps a long-lost friend or a family member. But be deliberate about the decision.

“It may not be the be-all, end-all the first time around,” she said. “But you have to find a way of feeding your social need bit by bit. And as you have successful experiences you gain more confidence. And you think, ‘Yes, I can do this.'”

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• Millions of older persons in SA are at high risk of developing severe symptoms or dying by contracting Covid-19
• Many older people are lonely and depressed and in need of assistance
• Seniors are concerned that many young people don’t take the pandemic seriously and don’t wear masks

Nosipho Nkayi (63) has become accustomed to walking the distance of about five kilometres from the Michael Mapongwana Clinic in Harare, where she collects her diabetes and high blood pressure medication, to her shack in Endlovini in Khayelitsha.

Nkayi recently injured her knee and needs crutches to move around. 

On Friday, (3 July) Spotlight found Nkayi on her crutches on the side of the road gasping for air after having walked more than a kilometre from the clinic. 

Back in her tiny two-roomed shack buckets of water are placed strategically on her worn-out carpets to catch rainwater leaking in through the roof of her shack. There are also buckets for water that Nkayi and her daughter has to fetch from the communal tap. 

Risks ‘too high’

Nkayi is one of millions of older persons in South Africa at high risk of developing severe symptoms or dying should she contract Covid-19. 

Khayelitsha, where she lives, also happens to be one of the hardest-hit areas in Cape Town. 

“Life during Covid-19 is a difficult one for me as an elderly person,” she says. “I had been suffering from chronic illnesses before and this coronavirus has exacerbated things. We are told to practice physical distancing, but it is hard if you are living in an area like this. I live in fear every day.”

Nkayi says the risks of contracting Covid-19 in Endlovini are “too high”.

“You come across different people who are not wearing masks every day. And the sad part is that you cannot avoid people here. They are right in your face. You step outside your shack and there is almost a crowd of neighbours who are sitting in the sun and they want to converse with you. You can’t lock yourself in your shack all the time. I am just putting everything in the hands of God and wearing my mask,” she says.

As of 1 July, updates from the Ministry of Health showed 1 541 of 2 749 Covid-19 deaths were recorded among people 60 years and older.

Most neglected in our society

Social distance should be redefined to mean physical distance when it comes to protecting the elderly during the Covid-19 pandemic, says Dr Leon Geffen from the Samson Institute for Research on the Aged.

“Physical distance must mean that we take care of the elderly no matter how far we are from them. That [includes a] phone call to check how they are doing. Many elderly people are lonely and depressed around this difficult time. Plus, they need help in terms of assistance with a lot of things such as collecting their Sassa grants, buying groceries and collecting their medication. We as the society have a role to play when it comes to these issues,” he says.

The elderly, he says, are the most neglected in our society and community groups can go a long way in alleviating their plight.

“Not only are they vulnerable to this pandemic, but they face a lot of abuse and exploitation. It would help if each and every community had a group that caters specifically to the needs of the elderly,” says Geffen.

Doing their best to stay safe

In some cases, older persons are taking charge of their own safety. Gogo Ntombizanele Jozana (68) says before Covid-19 “came and terrorised us, [she] was quite a people’s person and everyone came and went as they pleased in [her] house”. “But now I am very cautious about allowing visitors because the risks are too high. In fact, I always make sure that my gate is locked all the time in order to control the flow of visitors.”

Jozana says it pains her that the elderly are the ones that are adhering to the regulations more than young people.

“These young people don’t care about Covid,” she says. “They wander the streets without wearing masks and when you rebuke them they look at you as if you’ve got leprosy. It is quite sad because most elderly people sit at home and contract the virus from their children and grandchildren. As the saying goes ‘this virus doesn’t move around but it is people who do and spread it’,” she says.

Joined by her wheelchair-bound friend and neighbour, gogo Sylvia Gxabhagxabha, both feel it is “high time that government uses harsher measures to ensure that people follow the rules”.

“In the beginning, we were told that the army would be sent to the townships to ensure that rules were not broken, but that is not happening. If President Cyril Ramaphosa can send the army to patrol day and night, we won’t see this lawlessness ever again. People are scared of the army and they will start wearing masks and not wandering the streets,” says Gogo Jozana.

President Cyril Ramaphosa, during his address on Sunday, announced several restrictions, including a curfew between 21:00 and 04:00, stricter regulations regarding the wearing of masks, and the reinstatement of a ban on alcohol sales.

Public transport

For some older persons, it is not always possible to keep a distance. Like many people in South Africa, older persons in poorer communities depend on public transport to get around for groceries or to collect their grants. Another Khayelitsha resident, 65-year-old Mirriam September, says she hardly leaves her house out of fear of contracting the virus and asks a neighbour to fetch her Sassa grant.

In Harare township in Khayelitsha, Mzwakhe Mlobeli is getting out of a minibus taxi when Spotlight approaches him. Wearing a mask and carrying his groceries, the 65-year-old says he has become vigilant ever since the spread of the virus in Khayelitsha.

Ramaphosa on Sunday also announced that taxis may operate at 100% capacity, provided safety measures such as open windows are adhered to. But Mlobeli says it pains him that the youth are disregarding the rules, also in taxis.

“Just in the taxi I have disembarked from, I was appalled to see that I was the only person wearing a mask. It is quite sad. People look funny at you when you are wearing a mask. When I asked one young man why he was not wearing a mask, he said ‘these things are suffocating us’. With such behaviour, this virus is going nowhere anytime soon,” says Mlobeli.

Mlobeli suffers from high blood pressure. He says the virus has “turned our lives upside down” and he is praying that a cure can be found soon.

Mlobeli’s friend, Mhlontlo Masakala (64), tells Spotlight the news of the virus came at a time when he had just suffered a stroke.

“I suffer from high blood pressure and I am aware that I am at high risk of contracting and dying from this virus. Hearing that this virus has no mercy when it comes to the elderly, left me terrified. I am doing my best to stay safe but we are surrounded by young people who don’t seem to care. They are the ones who are putting our lives at risk,” says the father of three.

Community interventions

Lockdown has affected crucial social support services to older persons in poorer communities. One NGO, Ikamva Labantu had to suspend activities temporarily.

Lulama Sigasana, Head of Ikamva Labantu Seniors Programme, says it has been difficult for the “seniors”, as she prefers to call the elderly, during Covid-19 as they had to isolate themselves from their peers, their places of worship, and their seniors’ clubs.

Sigasana says before the temporary suspension of the seniors’ programme, Ikamva Labantu was providing the elderly with a service that included delivery of their chronic medication to the seniors’ clubs.

“This service is through collaboration with organisations that are part of the Chronic Dispensing Unit. We do, however, have seniors who prefer to collect their own medication from their local health facility. And these seniors have to arrange their own collection of medication,” she says.

“Transport for seniors is a problem,” says Sigasana, “especially when they use assistive devices like wheelchairs and they are seen to move slowly in a fast-moving environment. Some seniors, because of where they stay, are more compromised in terms of accessing transport as you have seen in Harare.” Sigasana says Ikamva Labantu often transports seniors to and from the seniors clubs but funding has been a challenge.

Dr Tom Ellman, director at MSF’s (Doctors without Borders) Southern Africa Medical Unit, tells Spotlight that shielding can play a critical role in protecting the elderly. Shielding refers to protecting those at high risk of severe illness such as older people by minimising interaction with other people. 

Giving young people a role

“With awareness of the risks, people can take measures to protect themselves better even without support. The more support that can be available from family, friends, community, and government, the more effective it will be. Shielding at home rather than moving into (Care) Homes will be more acceptable and more effective as well as less risky,” says Ellman.

When asked what needs to be done to warn young people about the dangers they pose to the elderly, Ellman says there are general efforts to promote awareness and clear messaging from peers highlighting the role of the young in supporting and protecting the elderly. 

“Giving young people a role, potentially employment, and awareness will be needed. For those living with elderly or vulnerable relatives, the dangers are personal and messages must adapt to that,” he says.

Ellman says it is unfortunate that some of the elderly continue to travel distances to seek medical attention. “Clinics,” he says, “can give longer refills, offer alternative pickups outside the clinics, allow relatives to pick up drugs, or even deliver drugs to the homes of the elderly.”

Ellman says government is already on board in a limited way but the key will be solutions and ideas coming from individuals and communities.

Living in abject poverty

“Support from government and community-based organisations must enable shielding by providing for the needs that cannot be met without exposing the shielded person to risk.” This includes food, income, healthcare, protection within the household, education and awareness and also supporting shielded people who may be caregivers or have other roles.

“The key for me is to ensure that individuals, families, and communities are empowered with the knowledge they need and come up with solutions themselves, facilitated by community-based organisations and government support where needed,” Ellman says. 

“The objective is to ensure that while up to 80% of the population may become infected in the coming months with Covid, the 20% who remain uninfected are those who would have been at greatest risk of severe disease or death. Shielding is focused on achieving that,” he says.

Khayelitsha Ward Councillor Lulekwa Jali says the issue of the elderly in the impoverished areas, is a sensitive one. Jali says it pains her to see the elderly living in abject poverty and having to face the Covid-19 battle.

“As councillors who see their plight daily,” she says, “we try by all means to address the issue affecting the elderly through social intervention methods. On the issue of housing, there is a backlog and, where there are desperate cases, we always try and get private donors or Good Samaritans who come and assist,” she says.

Government responds

Spokesperson for the Department of Social Development in the Western Cape, Esther Lewis, says when it comes to the elderly the department “prioritises everyone and we are doing our best to ensure that they are taken care of during this pandemic”.

Asked how the department is addressing the challenges of the elderly, such as Gogo Nkayi who have to walk long distances to access their medication, Lewis referred Spotlight to the Department of Health which had not responded by time of publication.

In a statement released by the Western Cape Department of Health on Friday 10 July, the department reminded persons over the age of 55 and those with chronic conditions that they are at risk for severe Covid-19 illness and should take extra precautions to protect themselves by following the steps which include avoiding getting the virus by staying home and wearing a mask when they have to go out.

According to the department, it has since 1 April, through community health workers (CHWs), been able “to deliver 335 320 medication parcels to the homes of those members at high risk of contracting severe COVID-19 illness”. However, of these, “52 650 parcels were returned due to incorrect address details”. CHWs visited “943 982 members of the community in their homes (Metro 720 086; Rural 223 896), providing them with basic health services [so that they do] not have to leave their homes and risk contracting Covid-19”.

The Department says it has implemented an action plan for Diabetics with Covid-19 symptoms which includes expanding testing for diabetics. “Our current data suggest that these patients are presenting or are being admitted too late in a very sick condition, which has dire outcomes. Diabetic patients are encouraged to stay home and access the Pocket Clinic WhatsApp channel to ensure their medications are delivered to their homes. Patients are encouraged to send ‘Hi’ to 087 240 6122 to ensure we are able to deliver their medication at home,” the statement reads.

*This article was produced by Spotlight – health journalism in the public interest. Sign up for our newsletter.

^{Image credit: Nasief Manie, Spotlight}

Siyabonga Kamnqa

Prominent scientists call for so-called “challenge trials” to accelerate vaccine development.

A patient who says she had no confidence for years joins surgeons to call for surgery to resume.

• When the coronavirus pandemic started, there was a sharp increase in cases of stress cardiomyopathy in the US
• This condition seems like a heart attack, but is something quite different
• So-called ‘broken heart syndrome’ appears to be caused by stress

Doctors at one Ohio hospital system have discovered yet another possible consequence of the Covid-19 pandemic: More cases of “broken heart syndrome”.

The condition – which doctors call stress cardiomyopathy – appears similar to a heart attack, with symptoms such as chest pain and breathlessness. But its cause is different: Experts believe it reflects a temporary weakness in the heart muscle owing to a surge in stress hormones.

And at two Cleveland Clinic hospitals, diagnoses of stress cardiomyopathy shot up in the early weeks of the Covid-19 pandemic.

During March and April, the new study found, stress cardiomyopathy was diagnosed in nearly 8% of patients who arrived in the emergency department with chest pain and other possible heart symptoms.

Stress of the pandemic

That was four to five times higher than rates seen in pre-pandemic periods, which hovered between 1.5% and 1.8%.

And while Covid-19 can lead to heart complications, none of the patients with stress cardiomyopathy tested positive for the infection, said Dr Ankur Kalra, a cardiologist who worked on the study.

“That suggests this is not a reflection of the virus, but the stress of the pandemic,” he said.

Stress cardiomyopathy is a relatively new diagnosis, and doctors are still trying to understand it fully, Kalra said. But it got its nickname because it may arise after an emotionally difficult event, like a divorce or death of a loved one.

But other stressful situations – from a traffic accident to surgery – can also be triggers, Kalra said.

The condition may not arise immediately after the trigger, however, said Dr David Kass, a professor of cardiology at Johns Hopkins University School of Medicine in Baltimore.

Distinct from a heart attack

Kass said a person could, for example, develop stress cardiomyopathy after living through an earthquake then dealing with the fear of another one.

The condition is thought to occur when the heart muscle is overwhelmed by a flood of catecholamines – better known as stress hormones, according to Kass. That temporarily reduces the heart’s pumping ability.

The condition is quite distinct from a heart attack, he explained. There are no blockages in the arteries, and while heart muscle cells may be temporarily stunned, they do not die off.

The symptoms do mimic a heart attack, said Dr James Januzzi, a trustee with the American College of Cardiology and a cardiologist at Massachusetts General Hospital in Boston.

But as tests are done, he said, the true cause grows clearer.

For one, Januzzi explained, stress cardiomyopathy looks different from a heart attack on electrocardiogram, which measures the heart’s electrical activity. And when doctors do an angiogram to peer inside the heart arteries, they’ll find no blockages in a patient with stress cardiomyopathy.

People avoiding the ER

The good news, Januzzi said, is that people with the condition typically recover quickly, with no long-term heart damage.

Kass said that given all the stresses of the pandemic – from fear of the virus to job losses to social isolation – it’s not hard to imagine why stress cardiomyopathy would increase.

But he also sounded a note of caution on the findings: From the start of the pandemic, many US hospitals saw a significant drop in heart attack patients – possibly because people feared a trip to the ER and were not calling 911.

And that, Kass said, could be one reason why the percentage of stress cardiomyopathy diagnoses rose.

“The denominator has changed,” he said. “So it’s hard to know whether this is actually happening a lot.”

Januzzi agreed that could be a factor.

Managing stress

What’s interesting, he said, is that none of the patients tested positive for Covid-19. Cases of “Covid-associated” stress cardiomyopathy have been reported in patients with the infection, Januzzi noted, but cases associated with the pandemic itself would be new.

And it’s “very plausible”, he said, that these stressful times could be leading to a true increase in the condition.

For the general public, Januzzi said, it’s critical to act on symptoms of chest pain and difficulty breathing: Get to the ER and let doctors diagnose it.

Kalra agreed. He also urged people to do their best to manage stress – getting regular exercise, for example, or using meditation to quiet the mind.

The findings were published online on 9  July in JAMA Network Open.

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• A new rapid blood test kit for Covid-19 has been approved in SA
• The regulatory authority (SAHPRA), however, faces criticism for taking its time to approve applications 
• SAHPRA replied that caution is of the utmost importance, even if approval takes longer 

The first Covid-19 antibody rapid blood test kit has been approved for use in South Africa, but it is strictly not for sale to the public or for use by general practitioners.

The South African Health Products Regulatory Authority (SAHPRA) has given the nod for the supply of a single finger prick (point of care) serology test. In addition, approval of the first laboratory-based Covid-19 antibody test in the country is also imminent. 

Dr Andrea Julsing-Keyter, SAHPRA’s senior manager for Medical Devices and Radiation Control, told Spotlight that a licence to supply the rapid test kit called Orient Gene Covid-19, had been given to Tip Top Trade (Pty) Ltd and that more applications for licences to supply the kit have been made.

The Chinese product has been authorised for use in China and has been approved by authorities there for export. Another antibody rapid test manufactured by the same company Zhejiang Orient Gene Biotech, was used effectively in a large Covid-19 serological survey in Spain.

Julsing-Keyter said the Section 21 authorisation allows SAHPRA to put conditions in place to ensure the rapid test meets principles of safety and performance. Section 21 authorisation is a regulatory mechanism that allows for the import and use of health products that have not yet been registered by SAHPRA.

Waiting for testing algorithm

The test will only, in fact, become available once the Ministerial Advisory Committee on Covid-19 releases its much anticipated national testing algorithm that will set out how serology test kits are to be used. 

“The algorithm will tell us the appropriate place, how and when the tests can be used,” said Julsing-Keyter. “Because serology tests cannot be used to diagnose Covid-19, they will be helpful for monitoring and surveillance for serological surveys, epidemiological studies and the identification of hotspots,” she said. 

Serology tests analyse blood to detect SARS-CoV-2 antibodies that are formed by the immune system in response to a past infection with the virus. They are useful in picking up evidence that a person had the virus even if they did not show symptoms. The tests are different to the swab or PCR test, used in South Africa, which can tell whether a person is currently infected.

Antibody serology tests, in general, are useful in establishing whether a person has acquired immunity to a virus and is also useful in testing whether or not a vaccine against an infectious disease is working. However, with the SARS-CoV-2 virus, there is currently not enough evidence to say whether someone will be immune and protected from reinfection even if they have developed antibodies to the virus.

Adapted from UK specifications

Julsing-Keyter said the specifications for the rapid test kit were adopted from the UK’s Medicines and Healthcare Products Regulatory Authority, with whom South Africa has a memorandum of understanding. “The UK specifications for sensitivity of the test is 95% and we dropped ours to 85% to accommodate mid-performing tests. The specificity of the test is 98%,” she said.

The sensitivity of tests is important for avoiding “false negatives”, in which the patient’s blood appears free of antibodies against SARS-CoV-2 despite having previously been infected with it. 

The specificity of the test is important for avoiding “false positives”, or giving a positive result to a different but similar virus, for example, a coronavirus such as SARS1.

Criticism of SAHPRA

Approval for the Orient Gene Covid-19 antibody (POC) test kit comes amid sharp criticism levelled at SAHPRA by some researchers who have complained that the regulatory body has dragged its heels on approving laboratory-based antibody tests as important “weapons” in the arsenal to fight Covid-19. 

The accusations were expressed in an opinion piece in the Daily Maverick, with the authors saying SAHPRA “is overly cautious” in not allowing serology tests to be used by professional clinical laboratories, and that it is “frightened by the mistakes” some countries have made in buying home-testing point of care finger-prick tests as epidemic control tests. They have questioned whether SAHPRA regulators have the necessary expertise to evaluate data or whether they are “just misinformed”.

Julsing-Keyter responded saying SAHPRA had “numerous engagements” with the authors who “work for private laboratories”. She said they sent in data and applied for authorisation for laboratory tests that were illegally imported in terms of the 2017 amendment to the Medicines and Substances Related Act 101 (1965) which regulates medical devices and laboratory diagnostics. “You cannot manufacture, import, export or wholesale without a SAHPRA  licence,” she said. “Their laboratory-used kits are illegal.”

She said there has been “a flurry of illegal test kits on the market”, adding that she gets six or seven reports daily informing her of more unauthorised kits. This is “totally unacceptable especially when you see the repercussions of tests being used by the wrong person”. She said SAHPRA was “on high alert” for devices that had been approved for export but had not been authorised for use in the country of origin.

Better than lab tests

Orient Gene Covid-19, the approved rapid test kit, performed far better than the laboratory-based tests, said Julsing-Keyter. The rapid test would also be cheaper, easier to use and could reach more people from a public health perspective. Laboratory tests required drawing blood from a patient and then processing the sample in a machine in a lab to get a result.

However, she said, the rapid test could not be used in situations where there was low prevalence of the virus. “It’s a mid-level performance test, so it is not accurate enough to be used by a GP, a pharmacy or an individual.”

While she acknowledged that the laboratory-based test performs well and meets the specifications when used in patients who are 14 to 21 days post-exposure to the virus, she said the rapid test works earlier post-exposure so there is less need to wait. “It’s because of this caveat that we have not released the laboratory-based tests yet.” 

In addition, she said, “We have also turned down many applications for laboratory-based tests because they just did not meet our standards for sensitivity and specificity. We have been accommodating in terms of the specifications but we must be steadfast. If this is the specification, you need to meet it. If not, you don’t get authorised. We are on the verge of approving laboratory tests but they will be limited in numbers as many do not meet the specifications.”

The regulator had been inundated with submissions which are screened and then forwarded for performance evaluations. “It’s been a dynamic process and we are also learning as we go.”

Julsing-Keyter said the specifications are published on the SAHPRA website where the target product profile for authorising an antibody test kit is outlined. “Our process is transparent. Applicants can see what standard is needed to authorise a test kit for use.” 

Once an applicant has been reviewed, the regulator sends the kits to the National Health Laboratory Service (NHLS) where a battery of tests are run to evaluate the product. “If it passes the specifications, it’s authorised, if not it is rejected,” she said.

The process is in line with global best practice where all regulators go to their national reference laboratory, who determine the protocol. Scientists at the NHLS work closely with the World Health Organization (WHO) and follow international best practice when developing the protocols that must be used for performance testing, she said. “South Africa and the NHLS has a wealth of experience with these type of test kits for HIV and tuberculosis, so there is a wealth of knowledge in terms of protocol development,” Julsing-Keyter said.

‘We have to be cautious’

“We have to be cautious in these uncertain times. Our mandate is to ensure the safety of a diagnostic device, its efficacy and its quality. If we do not have accurate tests, we are opening ourselves up to chaos.” 

She said test results influence behaviour and policy and so it was essential to tread carefully. “We don’t want to flood the market with tests and then have to recall them as happened in the USA.”

Julsing-Keyter said in South Africa test kits for Covid-19 are classified as Class D medical devices meaning that they are high-risk products in terms of how invasive they are and their duration of use. Class A would be a wooden tongue stick and Class D would be a hip implant.

Licences for the manufacture or importing of high-risk devices will be given only if evidence is provided that the devices are registered for use in one of six jurisdictions namely USA, Europe, Canada, Australia, Brazil and Japan or if the device has been pre-qualified by the WHO.  

Julsing-Keyter said Covid-19 presented a challenge as no Class D test kits for Covid-19 were registered in the six jurisdictions. “Europe initially relied on self-declaration which we could not rely on and the US Food and Drug Administration’s approach is to accept applications and authorise upfront, and as they review, they will recall devices.”  

SAHPRA could not do this “kind of retrospective” action as it does not have the capacity “to control it [the process]”. “It’s easier for us to control it upfront and rather release a good product onto the market than allow the market to flourish and then try to pull off non-compliant tests after the fact.”

The other quality control measure in place in terms of Section 21 is for the NHLS to do a lot-to-lot sample verification before release which is part of SAHPRA’s quality control mandate.

“We are custodians. It’s a matter of public health. If we don’t protect the public, there will be massive repercussions… so what if we are perceived to be cautious… we would rather [be] this than having masses of inaccurate results that inform poor behaviour that will put the population at higher risk… We don’t want to have recalls… We consider recalls very serious,” she said.

*Adele Baleta is an independent science writer, media consultant and trainer 

*This article was produced by Spotlight – health journalism in the public interest.  Sign up for our newsletter.

^{Image credit: Getty Images}

Adele Baleta