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The Ministry of Health and Wellness is facing strong criticism from personnel in the health sector over the slow pace of its COVID-19 testing programme, even as allegations surface that it breached government policy by allowing the importation of 100,000 test kits which had not been approved by the World Health Organization (WHO) and the United States Food and Drug Administration (FDA). Among those who say the health ministry is failing to do sufficient tests for the virus is Dr Carolyn Gomes, a member of the board of the Global Fund for HTB and Malaria and, since last year, a civil society representative on the Access to COVID Tools Accelerator, which was established to develop measures to fight COVID-19.According to Gomes, since last year the Global Fund and a partner organisation have been working to develop and distribute testing kits for COVID-19 to make sure that they were up to standard and pre-qualified by the WHO."Some money was raised to make these tests available to low-income, lower middle-income countries across the world, and upper middle-income countries that were beneficiaries of Global Fund grants. Since last year I have been trying to encourage our Government to make greater use of the diagnostic tests that were developed, which are the antigen rapid diagnostic tests (RDT) for COVID-19, with very little success."More recently, the WHO has come out very, very strongly stating that we should be testing one person per thousand population per day. If we say Jamaica's population is 2.8 million people, then we should be testing 2,800 people per day in order to control and get a handle on our COVID-19 epidemic," argued Gomes.She noted that Jamaica is not meeting that minimum standard and pointed out that the WHO has recommended that the RDT antigen tests should be used widely to determine the state of the epidemic and to test everyone who is potentially positive for COVID-19."But we are not doing that in this country. We have limited severely the access of the population to COVID-19 testing to those who have money and can afford to pay anywhere between US$20 and US$50, sometimes more," said Gomes.She pointed out that the access to an antigen test is also limited to private entities unless the person has symptoms and goes to a public facility."And the Government, because of its limiting of the testing to selected providers, basically allows those providers to charge what they want to for the test. So an antigen RDT... which cost US$2.50 to make and supply from the approved WHO suppliers [is being sold in Jamaica for up to US$50]."So, essentially, what we have done is create a market that allows serious profit-making by restricting the access to the tests while not, in any way, providing the testing for those who don't have the money," added Gomes as she urged the Government to ramp up testing and make the antigen RDT tests easily accessible to all Jamaicans."By our reluctance to allow widespread use of the antigen RDT we are limiting and allowing a severe inequity and a severe potential for massive profit-taking limited to a few," charged Gomes as she noted that the Global Fund would provide Jamaica with access to a large number of antigen RDT through grant funding.Gomes' arguments are bolstered by the fact that other jurisdictions have introduced self-testing as a means of getting a true picture of COVID-19 infection rates.Yesterday, Australia started making COVID-19 self-testing kits available in supermarkets and pharmacies, following last month's approval by that country's medical regulator, the Therapeutic Goods Administration.The rapid antigen tests, being sold for between A$10 and A$30, will provide results within 15 minutes and do not need to be carried out by a health-care professional.In the United States, self-administered COVID-19 tests are widely available and can be done free of cost at CVS Pharmacy locations.Last month, Air Canada launched a new self-testing programme which the carrier said was aimed at making it easier for customers to travel.Passengers now have the option of buying self-administered COVID-19 tests and testing themselves while abroad before they board their flight back to Canada, the airline advised, adding that the tests meet the Canadian Government's testing entry requirements without the need to visit a foreign COVID-19 testing clinic.At the United Nations climate summit now on in Glasgow, Scotland, delegates are provided with self-testing kits, one of which is a polymerase chain reaction (PCR) test administered upon arrival at their hotel, the others being antigen kits to be self-administered daily. The samples are to be left at the hotel lobby from where they are taken to a lab.Yesterday, one local businessman who travelled to the US recently agreed with Gomes' assertion that the Government's insistence on limiting the provision of testing to selected providers is making it difficult for poor Jamaicans to get tested.He also questioned the rationale of having the tests administered by registered nurses only, arguing that what that does is to place further burden on the nurses whose expertise and skills are more needed at hospitals and clinics.Additionally, he said, "If we don't get to the point of mass testing we won't have a big enough base to really know what is going on with positivity rates."Among the local private sector entities approved to conduct antigen tests is an entity outside of Kingston, which Jamaica Observer sources say the health ministry's public lab and standards department allowed to import 100,000 D Biosensor Standard Q COVID-19 antigen tests from India with the product code RK055-25.But the WHO has since indicated that the antigen test with that product code is not among those which it has approved for use.Additionally, the antigen test kits imported from India are reportedly not approved by the FDA.Under Jamaica's Disaster Risk Management Act (DRMA), only antigen test kits approved by the WHO or the FDA, which have been validated by the National Public Health Lab, are allowed to be imported and used in Jamaica.The importation of testing kits, which are not approved by the WHO and the FDA, would be a potential breach of the DRMA.Additionally, there are concerns that the antigen test kits which are not approved by internationally trusted agencies could be significantly less reliable in determining a person's COVID-19 status when compared with testing kits which are approved by both the WHO and the US FDA.According to Observer sources, the sensitivity of the non-WHO-approved antigen tests is 84.38 per cent compared to 97.14 per cent for the WHO-approved tests.The sensitivity indicates the ability of the test to correctly identify patients who have COVID-19. A potential consequence of that development is that non-approved kits will have a higher chance of incorrectly diagnosing patients.This means that the antigen kits from India, which the health ministry's Public Lab and Standards Department allowed to be imported, could possibly have produced a series of false results.The Standards and Regulation Department of the Ministry of Health and Wellness is required to consult and get the permission of the ministry's public health lab to ratify that a product is fit for purpose before it permits importation of the product into Jamaica.It's not immediately clear whether that process was observed in respect of the controversial kits.Up to press time there was no response to questions sent to director of National Laboratory Services Dr Michelle Hamilton more than three weeks ago.The Observer had asked Dr Hamilton to respond to reports of the importation of test kits that had not been approved by the WHO and the FDA and the basis on which the permit was granted.The Observer has decided to withhold the name of the company which is reported to have imported the kits while investigations continue.But, in a terse response to questions from our news desk, the attorney representing the company said it has acted in accordance with the laws of Jamaica, as well as guidelines and directions issued by the Ministry of Health and Wellness from time to time insofar as it concerns the importation and administration of WHO-approved COVID-19 test kits in Jamaica.According to the attorney, the approved test kits used by the company provide acceptable accuracy rates; hence, its approval for use across the world."The only complaint my client has received has been resolved by the supply of the necessary permits and approvals concerning the importation and use of the approved test kits," added the lawyer as he hinted that the company had received the green light to import the kits from the health ministry.