ArvaLab Europe (Arvali Ltd.), the IVD device distributor and healthcare management company behind the rapid test laboratory, has analysed around 80 rapid tests and has also been researching the best available SARS-CoV-2 rapid test products from the outset. His philosophy is that only the best in rapid diagnostics is worth buying, because every percentage point difference in the sensitivity of a product can mean the difference of lives. That’s why it does not market a single product, but always the most advanced product at the time. The aim is not to sell a product at any price, but to always offer the best. To this end, in addition to studying international literature, it carries out its own trials and tests with domestic laboratories and hospitals, and also obtains useful information through its own out-site testing. Based on this, the following shopping guide for antigen and antibody test buyers has been compiled.

On the traditional nose-hangar and the new nasal cavity tests

The nasopharyngeal antigen tests (for the identification of recent infections) are recommended for organisations where professional sampling is available, as it is particularly important that the samples taken are accurate. The Abbott Panbio Antigen Test is a product recommended by the Rapid Test Laboratory. While Abbott’s antibody test product has come under a lot of attack in the US, with independent studies showing that its actual sensitivity is significantly below the official values, Panbio’s antigen test has shown very reliable results, and data from several domestic trials have been analysed. With a high viral load compared to its overall sensitivity of 93.4%, the test is now close to 100% successful, but has scored around 85% in several tests. The product of the well-known American multinational is also used by the national public health and rescue services and some large companies.

It has a serious study, as does the Roche/SD Biosensor test, the two with the most independent research in the world. Edinburgh Genetics’ ActiveX Press product is still of similar quality to Panbio, the latter being slightly lower in price, especially in larger quantities. Clinical data show that the latter product has also been shown to be effective in the asymptomatic population, with slightly lower detection rates (around 10%) than in the symptomatic population.

These products rarely fail, but occasionally we have found a faulty series. In this case, the manufacturer will replace the product.

Abbott is a large global manufacturer, while Edinburgh Genetics is a fresh, innovative biotech company whose antibody test we have tested in the laboratory, and Edinburgh Genetics’ antibody product was one of the top few tests in the spring of 2020. All Edinburgh Genetics products are individually packaged, which makes them popular in many practices and also available in BENU Pharmacies (for professional use).

The Edinburgh antibody product is also very popular with companies. This tool is so sensitive that it can identify IgG antibodies even months after the disease has run its course (in our trial it was sensitive even when titrated 160-320 times, while the majority of tests have a sample hit rate in the 40-80, sometimes 80-160 range).

Top quality and consistent quality are important for aaránt

Roche’s antigen test has a slightly higher sensitivity than these products, used to be much more expensive, but is now available at a very realistic price. The advantage of this over Abbott and AMP is that it is packaged individually, which means it is more practical for smaller healthcare practices to use. There are private clinics that have been using Roche for months to their complete satisfaction, thousands of tests per month, with a significant PCR comparison base. Roche’s products are manufactured by SD Biosensor of Korea, whose products are also supplied directly to Hungary. We have heard reports from a private clinic in Western Transdanubia that several tests in one series showed false-negative results, but this can happen with any rapid diagnostic tool. Roche and AMP are in principle the two top antigen nasopharyngeal tests in our view, along with the US ACRO. With the Austrian AMP, which our parent company also uses in its tests, and with the US ACRO, we have not yet experienced any quality degradation, which has already occurred with Roche/SD Biosensor. The sensitivity of AMP is outstanding and its specificity 100%, currently difficult or unavailable.

We currently do not recommend purchasing German and Austrian tests

To meet the increasing demand in the German market, manufacturers either do not have enough capacity or they suddenly outsource production to China, but the quality of the imported products is measurably lower than the original German products due to the accelerated pace. We had a box that gave 7 out of the first 10 tests with false results. We have heard regular market complaints about the German MP BIO and NADAL products, especially the latter, over the last two months, so we have turned back shipments ourselves and have given up the right to distribute them.

The top tests are joined by a few Chinese products, the WIZ Saliva Test and Nasopharyngeal (not nasopharyngeal) Test and the NewGene Combined Nazopharyngeal and Sputum Test. The latter was found to be more sensitive than Roche’s product in a Swiss trial, while the former was included on the recommended list of the German BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte). This means that the sensitivity of the test is guaranteed to reach the 80% limit set by the WHO, and probably much higher. This is supported by independent trials by the Paul Ehrlich and Robert Koch Institutes.

NewGene has also launched Nasal and Nabs (Neutralizing antibody) products, which are also of high quality. The latter product indicates a more nuanced result than conventional antibody tests at the post-vaccination stage. The NewGene sputum test has both domestic and Kenyan trials, which indicate an average result of around 90%, which is considered outstanding for a sputum test.

Saliva tests

We recommend sputum and saliva tests mainly to institutions and organisations that do not test regularly, have taken all existing precautions, but want to increase safety with an easy-to-perform test as a last link in the chain of custody, with minimal supervision by staff, even remotely. If hygienic and safe sample collection and disposal in a lockable, hazardous waste container can be ensured, then WIZ and NewGene’s tools are an economical choice. The distributor ArvaLab sells them at a significant discount from stock or to order for over 2000 pieces.

Self-sampling devices also include LEPU’s Nasal product, available in 1 and 25 packs. Its actual sensitivity is around 93-94%, based on domestic testing, while its specificity is on average above 90% (reality and factory data usually differ, so it is particularly valuable to have actual analytical results. The reality is often 5-10% or sometimes a much higher percentage of poorer results than the clinical studies in the factory.

ACRO is the test of the ears

ACRO’s US antigen test is also top quality, and its quality is extremely stable, with virtually no quality problems in our own testing over the past year and no negative feedback. It has a high sensitivity of over 97%, a specificity of over 99% and an excellent price/performance ratio. The US-based global company, which also produces hundreds of professional rapid tests and has a base in China, has a combined influenza A/B antigen test with similar parameters. The advantage of the ACRO antibody test is that it is S+N protein-based, i.e. it can detect both viral proteins and can also identify mutant antibodies, and in the case of vaccination, it can detect antibodies produced by Pfizer and Moderna vaccines. That is, it can be used to check the effectiveness of the vaccination. The majority of antibody products are N protein based, because research shows that more of it is available and its presence is more stable, thus the ACRO (S+N) test is more valuable.

JoinStar’s sputum, saliva and faeces-based test was used in our own -low sample- trial, which showed promise based on sputum samples, but we do not recommend it for saliva sampling. It is also “S” protein based, and the factory claims that it is highly reliable for the detection of mutating viruses. Another interesting feature is that it works on the basis of stool samples, which means that it can detect the virus for up to 40 days, i.e. as an antigen test it has a detection capability comparable to antibody tests! In other words, if the person has a sputum or saliva test and a stool test, the results of the two can give more information (if only the stool test is positive, the patient is over the infection, if only the sputum/saliva test is positive, the infection is still fresh and the viral load is high. We are currently conducting further experiments with it and will update our post on the basis of these results.

The advantage of sputum and saliva tests is that they can predict who is “super-infectious” and who is more likely to develop severe symptoms

These tools are more likely to find people with higher concentrations of the virus and who may have a more severe course of the disease, according to a Science magazine article. Therefore, it is worth using alone or even in combination with other antigen tests, because if there is no laboratory background that can detect the extent of viral load, a sputum or saliva test can provide an important immediate indication.

As there are hardly any independent studies or trials in the world that target specific tests, it is not worth taking the risk. It is only recommended to buy a test that is backed by such independent testing.

The other new development direction is nasal cavity sample-based tests

Products from Abbott and Roche are already available and look promising. The clinical trial showed that they are so easy to use that Abbott had 100% of the same success rate for lay samples as professional samples, while Roche had minimal difference. Edinburgh Genetics also has a product ready to go, ACRO is already available to order, and there is also WIZ and LEPU in this genre, available from stock.

In addition to sputum and saliva tests, they are also suitable for self-sampling with minimal supervision by medical staff. This can be a great advantage for many SMEs and large companies that previously performed PCR self-sampling, as it can reduce antigen testing fees above HUF 12,000 to around HUF 3-4,000. In the nasal test, both WIZ and LEPU were recommended, the latter, for example, apparently performing better than Abbott in the domestic trial. These products are slightly more accurate than saliva tests and have a sensitivity approaching or reaching that of nasopharyngeal tests.

In summary: review the User Guides, but do not accept them as the sole source of information. Look for independent clinical studies or trials, talk to market players who use tests in large quantities. Let’s make decisions based on them.

Our articles are constantly updated.