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.

EU Emblem mit Schriftzug Europäische UnionThe 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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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...

 

New study - SARS-CoV-2 immunity after infection or not? Hide Article

A study by Long et al., recently published in the renowned scientific journal "Nature" (https://doi.org/10.1038/s41591-020-0965-6), strongly emphasizes why it is necessary, during and after the corona pandemic, to use readily available and efficiently performed antibody tests such as enzyme-linked immunosorbent assays (ELISA).

In the study mentioned above, Chinese researchers around Long and Huang compared samples from the megacity Chongqing. They examined samples of 74 patients with and without symptoms. After an infection, the body generates an immune response to eliminate a pathogen. The immune system first produces IgM and IgA antibodies. Once the pathogen is recognized and fought, IgG antibodies are produced. IgG antibodies offer some protection against future SARS-CoV-2 infections and are detected in the blood as so-called antibody titers. These IgG antibodies form the memory of the immune system for many years. Vaccines work similarly by teaching the immune system to produce antibodies to protect against specific pathogens.

Quantitative antibody tests that target neutralizing antibodies are among the most important tools for clinicians to determine a titer that reflects the value of a protective immune response to infection. Thus, the titer required for an effective vaccine can easily be determined using our SRS-CoV-2 AESKULISAs.

Long et al. have investigated this fact by measuring IgM and IgG levels in patient samples using ELISA. Even though the sample of patients is small, the study shows no insignificant decrease in antibodies in the patient group with mild to mild symptoms. Only 62.2 percent of patients in the group without symptoms still had antibodies in their blood a few weeks after infection. In the group of symptomatic patients, 78.4 percent still had antibodies in their blood.

After approximately eight weeks, follow-up examinations showed that the antibody concentration in the blood of the symptom-free patients decreased by 81.1 percent. In the group of symptomatic patients, the decrease was only 62.2 percent. The group of Long and Huang also identified patients positive for SARS-CoV-2 by ELISA, who had previously been categorized as negative by RT-PCR. An examination of the samples for cytokines involved in the immune reaction, including G- and M-CSF, IL2, IL6, CCL2, IFN-γ, shows that patients with symptoms had a higher value of these proteins, which indicates a stronger immune response.

Even though the study mentioned above only involved a comparatively small sample, the results cast doubt on previous assumptions that strong symptoms represent a high risk of infection and that anyone who has survived an infection is immune to future infections.

At Imperial College London, Professor Altmann confirms the present study, stating that most infected people show only mild or no symptoms at all. The crucial question is whether they have sustained protective immunity. For him, it is an essential but also worrying point, that many patients in the study showed a significant drop in antibody concentration only 6-7 weeks after the disease's onset. Long et al. write that the decrease in IgG and neutralizing antibodies in early convalescence will influence the immune strategy and serological investigations.

That is precisely where AESKU sees the primary clinical utility of its quantitaive AEKULISA SARS-CoV-2 tests and offers six different kits for detection and monitoring of the immune status.

 

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Tracing the Virus - AESKULISA SARS-CoV-2 Antibody Tests

A secure future thanks to quantitative SARS-CoV-2 AESKULISA tests

Corona VirusIn the current situation, it is hardly necessary to argue about the urgent need for an effective and robust vaccine to treat COVID-19, because our society and humanity itself are in a state of emergency. However, not only a vaccine is urgently needed, but the success of vaccination must also be verified using quantitative tests. Quantitative tests react to neutralizing antibodies, i.e., antibodies responding to a pathogen and breaking it down, make it possible to determine the success of an immune response and a vaccination in everyday practice.

For the determination of an immune reaction, the examination of immunoglobulins, so-called antibodies, has been established for years. Since protein structures on the surface of a pathogen (bacterium, virus) are specific, i.e., unique for individual structures, the immune system forms the appropriate antibody; it is possible to examine different antibodies for confirmation and infection. In the case of SARS-CoV-2 viruses, the nucleocapsid protein (N) and the spike protein (S1) are suitable.

 

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HNL chooses HELIOS for complete IFA Automation of ANA testing

hnl interview image sHealth Network Laboratories (HNL), a regional leader in laboratory medicine, provides high quality personalized laboratory services in Eastern PA and Southern NJ. 

The immunology laboratory at HNL is led by Kimberly Pacella, Director of Clinical Operations. Kim and her team decided to implement the AESKU HELIOS, distributed in the US by Grifols Diagnostics Solutions. The HELIOS, a revolutionary new platform that employs automated immunofluorescence (IFA) technology to process and analyze patient samples, is the first clinical platform to offer the highest level of automation.