Kathmandu, Jan. 30: With the number of new COVID-19 cases confirmed every day in the thousands and the symptoms caused by the new Omicron variant of the coronavirus, responsible for 88 per cent of new infections in the country as per the Ministry of Health and Population, so similar to the common cold and the flu, the need for testing has skyrocketed.
While reverse transcription real-time Polymerase Chain Reaction (RT-PCR) remains the most reliable method for detecting COVID-19, it is only available at designated laboratories and takes hours to deliver results. That is why many people have begun opting for self-testing through the antigen-based rapid test kit available in the market.
This kit allows individuals to test themselves and confirm the status of infection in 15 to 30 minutes. But experts warn against taking these results at face value and fear that incorrect sample collection and the lack of medical supervision may be leading to ‘false negatives.’
What is a self-testing kit?
A self-testing kit, in the case of COVID-19, can be understood as a rapid test for the detection of the coronavirus in the specimen collected by an individual on themselves or their kin with or without the presence of a health worker. As of the time of writing (January 29, 2021), the National Public Health Laboratory (NPHL) of Nepal has approved one kit with the brand name Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) manufactured by the Chinese company ACON Biotech (Hangzhou) Co. Ltd. for use in the country. The kit marketed by Skytouch Biomed Pvt. Ltd. and is available at registered pharmacies across the country, the BigMart chain of supermarkets and e-commerce platforms including Infi Store and Daraz. The Flowflex kit, as specified on its packaging, is a lateral flow test for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab specimens and is for in-vitro diagnostic use only. According to Dr. Runa Jha, director of NPHL, the kit was approved in line with the COVID-19 self-testing guidelines 2021 issued by the Ministry of Health and Population (MoHP) on September 6 last year.
For a kit to be approved for use in Nepal, the guidelines require it to have first been authorised for emergency use by the Food and Drug Administration (FDA) of the United States of America or be in compliance with the Current European In-Vitro Diagnostic Devices Directive, that is, be CE-IVD approved. A kit needs only be approved by one of these entities to be opened for use in Nepal but in their advertisements, Skytouch has claimed that their kit is approved by both.
However, late last month, the FDA clarified that the Chinese-made Flowflex had not been authorised for use in the United States and ordered a recall of the kits from circulation. Another kit with the brand name Flowflex COVID-19 Antigen Home Test manufactured by an American company ACON Laboratories Inc. based in San Diego
and unrelated to the Chinese corporation of the same name is the one that has been approved by the American authority.
Nevertheless, the product being sold in Nepal has been approved by Europe and the manufacturer is an ISO 13485 company (according to TÜV SÜD, an international service corporation focusing on testing, inspection and certification) as required by Nepal’s 2021 guideline.
Talking to The Rising Nepal, Raju Shrestha, head of Sales and Marketing at Skytouch Biomed, assured that the Chinese kits, priced at Rs. 750, had been duly approved by all the relevant Nepali authorities and met the country’s standards. He also informed that the company had been importing these kits for the past seven months but shared that sales only picked up from mid-January this year. “For the past two weeks, we have been moving an average of 2,000 kits per day through pharmacies and our sales partners,” he said.
Accuracy
Skytouch claims that their testing kit is 98.8 per cent accurate. The health security committee of the European Union also found the kit to have a clinical sensitivity of 94.1 per cent in its retrospective in-vitro study. This means that the kit will correctly return a positive test for 94.1 per cent of people with COVID-19.
So the kit presently available to the Nepali people, in itself, may be reliable but that solely does not guarantee accurate results “because people also need to use it properly,” said Dr. Sameer Mani Dixit, general secretary of the Nepal Public Health Foundation and director of research at the Centre for Molecular Dynamics Nepal. “Normal people, untrained and unskilled, may not be able to collect their swabs as required which may get them a falsely negative result from the kit,” he said.
Medical Lab Technologist Krijan Man Vaidya also expressed the same concern. “Nasal swabs are hard to obtain. People may not push the sponge deep enough up their nostrils out of discomfort, they may not move it around as needed or particles from their hands or surroundings may contaminate the sample,” he said, adding, “When you consider these factors, the validity of the [kit’s] results becomes questionable.”
The authorities are well aware of this and hence, require all self-tests to be performed under the supervision of pharmacists or trained health workers, said Dr. Jha, quoting the MoHP guideline. However, this rule does not seem to have been enforced adequately, even in the capital.
The Rising Nepal talked to 10 pharmacies located in different areas of Kathmandu, three of Lalitpur and eight of Bhaktapur that sold this self-test kit and none of them knew that they needed to supervise their customers.
The situation is worse in the case of online stores that deliver the kit to people’s homes but provide no guidance whatsoever on how to use it.
The kit does come with a pictographic chart that explains how to collect and test the sample at home and a QR code directing potential users to an instructional video. “But not everyone will care enough to read the instructions or watch the video before using,” Vaidya pointed out.
Considering all this, NPHL Director Jha suggests people not solely rely on results from self-administered tests. “If the self-test returns a negative result despite you having COVID-19 symptoms then please get a PCR test done,” she advised.
At this point, it is worth noting that the MoHP only allows registered pharmacies to dispense self-testing kits. Yet, they are also available at supermarkets (BigMart) and on online stores.
Case tracking
Meanwhile, with people testing themselves at home without any monitoring by any agency, one has to wonder: how does the Health Ministry keep track of positive cases? Well the answer, as provided by Dr. Sangita Kaushal Mishra, spokesperson for the MoHP, is that it does not.
Responding to The Rising Nepal’s query via text messages, Dr. Mishra said that the ministry only used the Information Management Unit (IMU) COVID-19 register for its records.
Assistant Spokesperson Dr. Samir Kumar Adhikari said that the ministry also updated its records based on information provided by the local levels. However, no information is kept of people testing positive at home if they are not reported by the local governments, he said.
The 2021 guideline requires pharmacies to keep a record of the kits sold and report all positive results to the local health office on a daily basis. However, the pharmacies interviewed for this news said that no authority had asked them to provide such a report nor had the local level or any government body approached them for the data of people testing positive.
“The people buy the kits from us but they do not report back if they test positive.
There is also no mechanism for us to ask them,” said a Bhaktapur pharmacist who asked to remain anonymous for fear of losing business. “As stores first, I am sure pharmacies and online platforms keep a record of the number of kits sold but there is no follow up with the customers about the status of infection.”
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