The World Health Organization (WHO) currently recommend COVID-19 diagnosis by molecular tests which detect the SARS-CoV-2 virus RNA. However, these tests require well-equipped laboratory facilities, highly skilled technologists and multiple reagents. Currently, infrastructure limitations and supply shortages are limiting testing capacity below the growing demand for COVID19 diagnostics across Indonesia.
Therefore, access to reliable rapid diagnostic tests, in particular rapid antigen tests for COVID-19, could alleviate the pressure on laboratories and expand testing capacity to meet the most urgent medical and public health needs.
Rapid tests are qualitative or semi-quantitative in vitro diagnostics (IVDs), used singly or in a small series, which involve non-automated procedures and have been designed to give a fast result. For COVID-19, rapid tests may take around 10-30 minutes until giving a result compared with about four hours for molecular tests done in large series, or more if samples must be transported to a distant testing laboratory.
These rapid tests are relatively simple to perform and interpret and therefore require limited test operator training. They may be intended either for use in hospital laboratories or near the point-of-care. There are two types of COVID-19 rapid tests currently in use or in development: direct SARS-CoV-2 antigen detection and indirect antibody detection tests. Antigen detection tests detect viral components present during the infection in samples like nasopharyngeal secretions. Antibody tests detect the antibodies that later appear in serum as part of the immune response against the virus.
Rapid tests – that work like pregnancy tests (but detect antiviral antibody instead of pregnancy hormones) – on the other hand are faster and potentially cheaper, but have less accuracy than lab methods. Instead of a test tube, these tests use specially modified paper. The blood sample flows along the paper and gives that well-known “one line = negative, two lines = positive” stripes. Rapid tests are quick to manufacture and easy to use but have to be carefully designed and validated, which is why they are not approved for use and we haven’t seen widespread official use yet.
Quality control and validation adds significant cost to these tests: an unregulated test can be purchased for less than 50p – and it might even work – compared to a certified rapid test typically costing around £5.
As with vaccines, it’s absolutely vital that any test is accurate and safe, and that takes time and money. Inaccurate tests in the current outbreak could be devastating – imagine if you tested negative, but were infected, and went out and infected more people. Some of these tests have an accuracy around 80% – this has been intensively studied for many important viral infections such as dengue – which sounds great, except one in five test results is wrong. The error varies with the disease. For some infections, tests can give you a positive result if you’ve not had the coronavirus, because you have antibodies against something similar. For most of these rapid tests, you can read a negative result just because the line is hard to see. Even if the test works perfectly in the lab test, without training it’s easy to make an error when using them. Another advantage, then, of lab testing over rapid home tests is improved accuracy. By combining multiple tests, for example against lots of different virus fragments, accuracy can be improved. But this comes at the cost of needing more hands-on time and expert interpretation, not to mention lab equipment.
According to IVD Directive 98/79/EC, to affix the CE-mark to COVID-19 diagnostic devices to be used by health professionals, the manufacturer has to specify device performance characteristics and self-declare conformity with the safety and performance requirements listed in the Directive.
In contrast, self-tests intended to be used by patients themselves must also be assessed by a third-party body (a notified body). The dedicated Commission working group of Member States competent authorities for IVD serves as a forum for continuous exchange of technical and regulatory information on IVDs including COVID-19 rapid tests.
For compliant CE-marked rapid diagnostic tests, their performance may vary in the routine testing laboratory in comparison with the performance study of the manufacturer done for the purposes of CE-marking. Rapid tests may also be less accurate and less sensitive than laboratory-performed diagnostic tests.
Therefore, clinical validation of the diagnostic performance of rapid tests for COVID-19 in real-life should be carried out by comparison with a gold standard test in a sufficiently large number of target population subjects before introducing them into the routine as a stand-alone diagnostic test. WHO referral laboratories for COVID-19 are currently performing validation studies of commercial assays.
Scientific publications of results should soon clarify the clinical performance and limitations of rapid diagnostic tests and indicate which tests can be used safely and reliably for specific medical or public health purposes.
This contrast between accurate but laborious lab tests vs less accurate but portable rapid tests, is why research groups such as our own at the University of Reading have are working hard to develop novel microbiology and blood testing technology.
One major aim for innovators is to allow multiple laboratory tests to be performed in one small, portable and rapid device. At the same time, increasing scale of conventional, validated tests, for example by expanding NHS testing capacity, is equally critical to track and trace COVID-19 as the current pandemic develops. We all hope the current urgent need for tests will drive both rapid uptake of innovative technology, and at the same time boost our capacity to detect microbes and viruses using tried-and-tested laboratory methods.
In Indonesia especially in Bali, there are some places that offering rapid testy for COVID-19 if you are interested in checking yourself or you might develop symptoms of COVID-19. One of the place is Hydro Medical Clinic which located in Badung Regency, Bali, Indonesia. They will offer you a special package for testing the Rapid test of COVID-19. They will cost you around IDR 480K and you will get the consultant with doctor, the test and also the universal precaution for the medical staff.
So you don’t need to pay another fee for the universal precaution. Also, they already in contact with some of big hospitals in Bali, so when you need more action after the Rapid Test, they are always ready to assist you and make sure you will get the best treatment under their care. Hydro Medical Clinic also have trained staff for this test, so you don’t need to worry about anything rather than your own healthiness.
If you are interested in taking the Rapid Test on Hydro Medical Clinic Bali you have to make an appointment first through Hydro Medical Bali’s customer care. After you make an appointment, the day you come in to the clinic you have to wear the mask (this is necessary unless they can’t accept you).
After you are arriving at the clinic you have to fulfill the questionnaire that Hydro Medical Bali already prepared for you. After you answering the questionnaire the doctor will check your recent health condition. After the doctor approved that you need to be checked, then the doctor will check you. The checked are the same like you are checking the blood sugar. After the checking end, you need to wait for around 15 minutes, after the result come out the doctor will give you a suggestion based on the result of the rapid test.
After you get the result, if the result appears to be negative (one line) you still need to do the self-quarantine for 7-10 days and come back again to get the test in day 7 or day 10. If the result still in negative result, you are safe but you need to continue to do self-quarantine by your-self to make sure you do it for fully 14 days.
If the result appears to be positive but you are in healthy condition you still need to do the self-quarantine for 7-10 days and repeat the same mention as describe above. If your rapid test appears to be negative but you developed symptoms of COVID-19 the Hydro Medical Staff will help you to get the PCR Test at the hospital that already provided by the government of Indonesia. If the rapid test appears to have 2 lines and you also developed the symptoms of COVID-19 they will calls the ambulance and send you to the hospital to get further assessment for your condition. Those are some explanations on what Hydro Medical Bali can provide you by taking the Rapid Test check in our clinic.
During this pandemic, we suggest you to stay safe, wash your hands frequently, stay at home, wear mask, do exercise and pay attention to the sanitation around you. We all in this hard condition together, so let’s protect each other by do what we can do to reduce the spread of COVID-19 disease.