Development of an automatic rapid test system for blood diagnostics and immunoassays

AESKU. Group has received funding from the European Union's Fund for Region Growth 2014 – 2020 Program to develop an automated platform for the automation of Point-Of-Care (POC) Tests. Read more...

Biomex has carried out a study to establish the performance of the AESKU.RAPID SARS-CoV-2 Antigen Test in detecting the SARS-CoV-2 Omicron sublineages BA.4 & BA.5.

This study evaluated the diagnostic sensitivity of the AESKU.RAPID SARS-CoV-2 concerning the BA.4 and BA.5 sublines of the SARS-CoV-2 Omicron (B.1.1.529) variant. For this purpose, samples collected as anterior nasal swabs were analyzed. All samples were tested simultaneously for the AESKU.RAPID SARS-CoV-2 and real-time RT-PCR assays.

The overall diagnostic sensitivity of the AESKU.RAPID SARS-CoV-2 for BA.4 and BA.5 variants was 94.6%.

In summary, the results of this study show a very high diagnostic sensitivity for the AESKU.RAPID SARS-CoV-2 concerning the SARS-CoV-2 Omicron (BA.4 & BA.5) variants, meeting the requirements of >80% (rapid tests) compared to the SARS-CoV-2 real-time RT-PCR test. AESKU.RAPID can detect all samples collected within seven days of symptom onset.

The AESKU.RAPID SARS-CoV-2 can be expected to qualitatively detect the antigen of the SARS-CoV-2 Omicron (BA.4 & BA.5) variant in human swab specimens with a high degree of confidence.

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New study shows AESKU.RAPID SARS-CoV-2 could reliably detect all SARS-CoV-2 variants at appropriate concentrations or naturally occurring viral load

This study aimed to evaluate the diagnostic and analytical specificity and diagnostic sensitivity of the AESKURAPID SARS-CoV-2. For this purpose, samples were analyzed as anterior nasal swabs. All samples were tested simultaneously with the AESKURAPID SARS-CoV-2 and real-time RT-PCR assays so that all antigen and PCR testing methods were performed on the same sample.

The diagnostic sensitivity of the AESKURAPID SARS-CoV-2 from the positive samples with a Ct value less than 36 was 91.5%.

The diagnostic specificity of the AESKURAPID SARS-CoV-2 was 99.3%.

The AESKU.RAPID SARS-CoV-2 could reliably detect all SARS-CoV-2 variants at appropriate concentrations or naturally occurring viral load. Omicron variants (BA.1 & BA.2) were also readily detectable.

The overall accuracy of the AESKURAPID SARS-CoV-2 calculated from all correct results was 96.3%.

In addition, no cross-reactivity with various potentially interfering viruses or cross-reactive samples was detected. None of the samples from hospitalized patients with diseases other than CoViD-19 showed a positive result. These results confirm the results of the cross-reactivity assays.

In summary, the results of this study demonstrate diagnostic specificity and sensitivity for the AESKURAPID SARS-CoV-2 that meets the MDCG guideline requirements of >80%. In addition, the potentially interfering and cross-reactive samples tested on the AESKURAPID SARS-CoV-2 did not show positive results, indicating high analytical specificity. Therefore, it can be concluded that the AESKURAPID SARS-CoV-2 can be used to detect the SARS-CoV-2 antigen in human smear specimens qualitatively.

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Performance of AESKU.RAPID SARS-CoV-2 Antigen Test to detecting the SARS-CoV-2 Omicron sublineages BA.1 & BA.2

Biomex has carried out a study to establish the performance of the AESKU.RAPID SARS-CoV-2 Antigen Test in detecting the SARS-CoV-2 Omicron sublineages BA.1 & BA.2.

This new study aimed to evaluate the diagnostic sensitivity of the AESKU.RAPID SARS-CoV-2 concerning the BA.1 and BA.2 sublines of the SARS-CoV-2 Omicron variant. For this purpose, samples collected as anterior nasal swabs were analyzed and tested simultaneously with the AESKU.RAPID SARS-CoV-2 and a specific real-time RT-PCR assay.

The overall diagnostic sensitivity of the AESKURAPID SARS-CoV-2 concerning the BA.1 variant was 97.0%. 

The overall diagnostic sensitivity of the AESKURAPID SARS-CoV-2 concerning the BA.2 variant was 100%.

AESKU.RAPID can detect all samples collected within seven days since the symptom onset with a very high diagnostic sensitivity. It can be concluded with a high degree of certainty that the AESKU.RAPID SARS-CoV-2 can detect the antigen of the early SARS-CoV-2 Omicron variants in human swab specimens and surpasses the requirements of >80% for rapid tests relative to specified SARS-CoV-2 real-time RT-PCR tests.

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AESKU.AWARD 2022 goes to three outstanding researchers in autoimmunity

On June 10th, 2022, Aesku. Diagnostic’s “Aesku.Award for life contribution to autoimmunity” was awarded for the eighteenth time. Dr. Torsten Matthias, founder, and CEO of Aesku.Diagnostics, presented the awards to the prizewinners during the opening ceremony of the “13th International Congress on Autoimmunity”, which took place in Athens from June 10th to June 14th, 2022.

Dr. Matthias explained in his short introduction that the company considers the Aesku.Award an expression of its vision and philosophy, and he would like to share with this award the success of his company, from when others faced great problems, with those who achieved great things in the difficult time of the pandemic. Since its foundation 22 years ago, Aesku.Diagnostics supports explicitly interdisciplinary research in autoimmune diseases. He pointed out that it is one of the goals of the Aesku.Award is to stress the importance of research in autoimmune diseases and to show the progress in establishing autoimmunity as an independent field of study.

The prize was presented during the Opening Ceremony of the Congress. Read more...

Clinical Performance of AESKU.RAPID SARS-CoV-2 Antigen Test to detect Delta variant (B1.617.2)

Biomex has carried out a study to establish the performance of the AESKU.RAPID SARS-CoV-2 Antigen Test in detecting the SARS-CoV-2 Delta variant.

The testing was carried out with four infected and confirmed patients over a period of up to 9 days after onset of symptoms.A total of 26 nasal swabs were tested with the AESKU.RAPID SARS-CoV-2 Antigen Test and simultaneously analyzed through a PCR Test. The collection of the swabs was carried out in Germany with European subjects.

All samples up to Ct-values of 36.15 have been positive with the AESKU.RAPID SARS-CoV-2 Antigen Test. In some cases, even samples which have been negative in the PCR gave a slight positive result with the AESKU.RAPID SARS-CoV-2 Antigen Test. Thus, the requirement stipulated by the Paul-Ehrlich-Institut (PEI), that samples within the first 7 days after onset of symptoms should be detected positive, has been fulfilled.

In conclusion, the sensitivity of AESKU.RAPID SARS-CoV-2 Antigen Test to detect the delta variant is very high, as it detected all positive samples confirmed by the PCR.

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