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COVID-19 testing has become a cash cow for many local private doctors, some of whom are charging thousands of dollars for a single test, with some even engaged in the business without having the required accreditation from the Jamaica National Agency for Accreditation (JANAAC).A single antigen test costs upwards of $7,000 and the polymerase chain reaction (PCR) test is far more expensive.When the Jamaica Observer spoke to one medical doctor conducting testing it emerged that there is the prevailing practice of several approved labs selling tests to unapproved labs. In return, the unapproved labs state that they are affiliated with the approved lab and a percentage of each test is reportedly given to the approved labs as part of the deal."The whole thing break down. We were told to get JANAAC approval then we would get a rubber stamp of approval from Ministry of Health and Wellness (MOHW). The latter has not happened; Ministry of Health added additional layers to what JANAAC has, so no one with JANAAC approval who went through the established route has Ministry of Health approval. Those with Ministry of Health approval were given it by Ministry of Health, not JANAAC. So what people have been doing is to work with one of the Ministry of Health-approved labs, buy the kits at a mark-up, and give the labs a cut," the doctor told the Sunday Observer.The doctor went on to explain that labs purchase the kits for as much as $47,000 and resell for $2,500 per test to the unapproved labs. Each kit contains 25 tests; therefore, at $2,500 per test, the resale value is $62,500. That's the first profit. From there, additional mark-ups are applied to the cost of testing, squeezing consumers dry."This is why the testing price cannot come down. The policies of the MOHW are why the price can't go down. They say we need to have ISO certification, which can only be given by JANAAC, but after we get that MOHW refuses to endorse our facilities. Then those who are endorsed or approved by MOHW, some do not have JANAAC approval. And, to add fuel to the fire, they have just sublet their tests to everyone - creating their own black market and then consumers feel it," the doctor said."Even worse, you have the drive-through centres doing drive-through testing that Ministry of Health say should not be done. It's the heights of double standards, and whether corruption or nepotism, why standards have not been applied right across the board. Some are going out and having partnerships with doctors' offices that have had no inspection or approval. The cost will never go down because by the time everyone gets their cut the money mawga," the doctor added.In the United States, internationally approved COVID-19 test kits can be purchased at US$100, which translates to US$4 per test. Testing in the US is supposed to be free based on the passing of the Families First Coronavirus Response Act, which mandates that Medicare, Medicaid, other government plans, and most private plans offer COVID-19 testing and all testing-related services entirely. In essence, no co-payments, no deductibles, no co-insurance charges.US law requires insurers to cover testing and doctors' office, urgent care, tele-health, or emergency room visits as long as the service relates to the furnishing or administration of a COVID-19 test or to the evaluation of such individual for purposes of determining the need of a test. However, it does not prohibit charges if individuals go to an out-of-network provider.Additionally, if your visit does not result in a COVID-19 test, or if you are treated in any way besides getting a test, you could end up with a bill. Still, some individuals report paying between US$100 and US$200 for COVID-19 tests in America.Locally, the testing costs have created hesitancy among the general population with individuals arguing that they cannot afford to pay so much money for one test only to hear they tested negative.On the other hand, some consumers argue that, though a number of insurance agencies allow them to claim for the testing costs, they still hesitate as right now it is money they do not readily have, particularly with the current economic climate.In January the Private Sector Organisation of Jamaica (PSOJ) and the Medical Association of Jamaica called for a more robust and expanded testing environment, arguing that it would provide more options for individuals and businesses. They also said it would aid in reducing informality in the testing ecosystem and the time for implementation of appropriate public health measures.President of the PSOJ Keith Duncan told the Sunday Observer he still stands by the position that there needs to be liberalisation of testing so it becomes more affordable and gives a more accurate reflection of our COVID-19 status in order to better manage the outbreak.In a statement provided to the Sunday Observer on Friday, the PSOJ refreshed its position stating that the COVID-19 numbers we see are likely to be a gross underestimate of the real cases, which may be anywhere between three and 20 times the official count.According to the lobby group, the reported numbers represent the status of the nation as of two weeks ago, because by the time COVID-19 manifests itself people have been infected for up to two weeks.The PSOJ further outlined that relying on those numbers to plan therefore means you will always be behind and in a reactive rather than a proactive position, and it is the equivalent of showing up to a 400-metre race when your competitors are already running past the 200-metre mark. It said to get ahead, or at least abreast of COVID-19, particularly in the community spread phase, requires aggressive and widespread testing to identify people suffering from the virus, to unearth asymptomatic and pre-symptomatic cases, and in so doing implement early quarantine measures.The statement concluded that it is incomprehensible that the country is still having a debate about antigen testing, its role in the national agenda, the suitability of practitioners to perform the test, or the need for its widespread availability and implementation. According to the PSOJ, the science shows that antigen testing is simple and practitioners are more than equipped to administer them in their offices with training that can be completed in a day with adequate facilitators."We have to refresh our position as the science changes. We have to keep pace with the science or we will be left behind," Duncan insisted.Dr Orville Nembhard from Health Plus Associates, which has JANAAC approval, explained how the rules surrounding the approval process were flawed and how the "ministry lost the race from the get-go"."The ministry said that they were going to be doing antigen testing and they were bringing in kits. They said this but then there was no movement in relation to this. Kits were available online and manufactured all over the place so people, recognising the value of the antigen testing, brought in kits. These kits were not necessarily approved or tested but people were using them and giving results. But the ministry lost the race from the get-go in terms of not bringing in the kits and making them available. So unapproved kits made their way to the market," Dr Nembhard said."When the ministry did approve kits, the distributors that had them, they would not allow us to buy. When we went in to the distributor to buy the kits they said, 'No, Ministry [of Health] says I can't sell it to you,' so that perpetuated the continued use of the unapproved kits. And it wasn't until some amount of agitation and JANAAC got into the picture that persons would be allowed a kit to do the testing and to get qualified," Dr Nembhard explained."Once you got qualified you were now able to purchase the approved kit. In the meantime, unapproved kits are running wild in the market, because people are asking for testing and are getting results. The truth is, the majority of the kits out there are decent quality. That's where the race got lost from the beginning," he explained.Further, Dr Nembhard said another reason for the breakdown in standards and the development of a profitable black market is that after getting JANAAC approval the ministry says it also needs to approve testers."This I don't understand. JANAAC is the agency which approves the Ministry of Health laboratory. They are the approving agency. So why is it the ministry now is turning around and saying to JANAAC 'You're not qualified to approve an agency to do a test' when it's the same agency that approves them. There are some illogical issues in all of this. My centre has been approved for over six months now, but still ministry refuses to accept any certified COVID antigen testing from me, citing that I need their approval. We have attempted to get their approval on many occasions; we finally managed to get a response from them where they e-mailed us and told us what we needed to send them. We have done so, and here we are, more than four weeks later, no response from them," Dr Nembhard said."If I send a patient to the ministry with a positive result they tell them you got a test from an unapproved lab, we don't accept it, even though I have JANAAC approval. For me, it is clear they do not want our testing. There is no impetus to get us involved in the testing," he said."When ministry went ahead and approved certain laboratories for testing, they don't have islandwide cover. So clearly you are going to have people with pent-up demand and nowhere to go; hence, the unapproved kits, and people just grab it and have not looked back since," Dr Nembhard said.Most of the issue with antigen testing, he added, "is really a creation of the ministry. If you leave a vacuum, someone is going to fill it. That horse has bolted and it doesn't help that the ministry does not seem to be receptive to regularising even the persons who are JANAAC-approved", he said.Meanwhile, chief executive officer at JANAAC Sharonmae Shirley said, since the launch of the JANAAC Pre-Accreditation Approval Programme (PAAP) on January 21, 2021, the agency has received over 100 inquiries from entities interested in offering pre-accredited COVID-19 testing services to the public. However, as at September 1, 2021, there are only 31 PAAP-approved entities.Shirley said the agency has responded to queries received from individuals and businesses that have been approved/pre-accredited/accredited by JANAAC or the health and wellness ministry to provide COVID-19 testing. She also invited people interested in providing testing services to visit the JANAAC website at www.janaac.gov.jm/paap/accredited-approved-paap for a directory of PAAP-approved entities or www.janaac.gov.jm/accredited-cabs/labs, where they will find details on Fleet Diagnostic Laboratory, which is the only laboratory to be accredited for COVID-19 testing in accordance with the ISO 15189:2012 standard since April 2021.She added that the ministry's website www.moh.gov.jm/covid19/covid19testing that lists entities that had been approved by the health and wellness ministry prior to the commencement of the JANAAC PAAP is also referenced as appropriate.Concerning the racketeering operations of unapproved labs, Shirley said consistent with the management of the national accreditation programme since it began operations in April 2008, JANAAC has implemented systems to assess and monitor the services provided by accredited Conformity Assessment Bodies (CABs) within its accreditation scope.She said, as it relates specifically to the accredited laboratory and pre-accredited entities that have been JANAAC-endorsed to conduct COVID-19 testing, JANAAC conducts robust assessments and monitoring programmes to verify the consistent quality of test results used to determine patient care in the management of the COVID-19 pandemic.Shirley said where breaches are identified during the monitoring process, suitable action will be taken by JANAAC, which, depending on the nature of the breaches, may result in sanctions being levied against the accreditation and PAAP customers.With regard to the concerns raised by doctors with JANAAC approval that they are yet to receive MOHW approval, Shirley said JANAAC, in conjunction with the ministry, is in discussions with the MOHW to address matters raised by its PAAP clients.