Why was the control line developed

Corona rapid test: facts instead of half-truths

When are the tests used?

“The PCR swab test is ideally suited in the early phase of the disease, ie from the 1st day of the infection until the time when the person tested has shown clinical symptoms. During this time, however, those affected still have too few antibodies for the rapid test. A few days after the onset of clinical symptoms, such as cough or fever, the antibody concentration, i.e. the acute globulins (immunoglobulin M, IgM for short), increases steadily in the blood and experiences a peak around the 7th to 10th day, so that the sensitivity of the rapid test rises steeply to over 92 percent. We were able to prove this in a multicenter prospective study. In addition, the rate of a false positive test result is almost 0 percent. That means: If the virus cannot be detected with the PCR swab test, the rapid test is also negative, the person is not sick with COVID-19. "

Why do you need a rapid test? Isn't the PCR test enough?

“The PCR test is an elaborate virus detection method that delivers a result at the earliest after hours and currently only after a few days and has to be repeated for verification. This process strains the health system enormously, also from a financial point of view. Even if the disease has been overcome, the PCR test can still remain positive, although the patient is no longer contagious. Despite its certain error rate, the PCR test is rightly considered the gold standard. The SARS-CoV-2 rapid test is an optimal and inexpensive supplement that supports doctors and medical staff in their daily work. It shows directly on site safely, reliably and within a very short time whether those affected have already formed detectable antibodies and are sick with COVID-19 or not, without a laboratory and costly examinations. Another advantage can be seen in relation to the quarantine regulation. Because despite the corona disease cured, virus fragments can still be detectable in the nasopharynx, so that the standard PCR test has a positive result. The rapid test has a significant advantage here, as antibodies of the acute phase (IgM) usually no longer occur in the blood after the infection has passed, but only immunoglobulin-G antibodies from the late or post-illness phase. That means in plain language: The rapid test can show whether those affected have survived the disease or are still contagious. As a result, people can be released from quarantine quickly (more) and safely (more). The Robert Koch Institute also emphasizes that a test that detects specific antibodies in the blood could be useful for an epidemiological question, i.e. an observation on humans under real environmental conditions. The health system does not have anything comparable. "

Can you go wrong with the quick test?

"Yes. When the doctor or nurse does not draw enough blood for the test strip or do not use the correct amount of buffer solution. Errors also arise, for example, if an evaluation is carried out before the specified 20 minutes has elapsed, even if it is only 5 minutes, or test subjects are tested who are still in an early phase and therefore no or too few antibodies for the Have a quick test from PharmACT. An incorrect ambient temperature can also influence the result. Therefore, the SARS-CoV-2 rapid test should be carried out strictly according to the established test procedures. The control line must always be colored. Even a fine discoloration of the test line is to be regarded as a positive test. A detailed application can be found in each test kit. We are always available for any queries. "

Is there a further development of the rapid test?

"Yes. Because in practice there are occasional difficulties in recognizing the fine red line, which means a clearly positive test. Patients who carried the corona antibodies were therefore wrongly classified as healthy. PharmACT has therefore developed a reader that detects even the smallest staining of the corresponding test lines on the test strip and thus detects the smallest amounts of antibodies in the blood. This in turn leads to more safety for the medical staff. We are already using this electronic readout device for other rapid tests. "

Rapid tests for home use are now circulating on social media. What do you think?

“Consumers should keep their hands off it, because there are no quick tests for private use. People's fear is cashed in here. Medical products are subject to strictly regulated quality requirements, for example always have secured certificates such as a CE mark and are only intended for professional use. They also have to be disposed of professionally. "

Source: healthcare-in-europe.com, March 19, 2020