Abacus Diagnostica

Abacus Diagnostica manufactures and develops rapid polymerase chain reaction (PCR) instrument GenomEra® CDX for the decentralised molecular diagnostics of infectious diseases.

GenomEra is suitable for applications ranging from point-of-care (POC) to large-scale laboratory screening programmes.

This CE-marked, in-vitro diagnostic (IVD) platform consists of an automatic analyser and disposable test chips. These detect a wide range of diseases, including influenza A/B and respiratory syncytial virus (RSV), as well as healthcare-associated infections. The solution can also identify Group B Streptococcus, which is the leading cause of life-threatening infections in babies.

The small-sized GenomEra Test Chips are contamination-free and cause a low amount of plastic waste.

GenomEra CDX uses time-resolved fluoresce (TRF) to eliminate background fluorescence, which improves detection sensitivity and reliability.

A wide range of clinical samples can be processed, from stool to transport media, swabs, blood culture and plates.

The company's patented polymerase chain reaction (PCR) cycling principle achieves rapid thermal cycling using thermal blocks in different constant temperatures.

GenomEra® CDX requires a smaller sample volume than other devices.

Up to four samples can be tested at once.

Automated benchtop solution for molecular diagnostics

Abacus’ GenomEra is a benchtop instrument designed for the fast amplification of disposable and ready-to-use test chips containing reverse-transcription (RT) PCR reagents in a stable, dry format.

These chips provide a simple and cost-effective solution for daily reverse-transcription RT-PCR testing.

Abacus’ proprietary software is easy-to-use and automatically interprets results to indicate a clear positive / negative outcome.

All GenomEra tests are performed without DNA / RNA extraction, reducing time requirements to less than two minutes per sample. Results are available in around one hour.

Molecular diagnostics instrument for respiratory infections

Abacus’s GenomEra Flu A/B + RSV testing kit replaces quick tests that are commonly used for influenza and RSV diagnostics, which are not always reliable.

GenomEra Flu A/B + RSV offers a wide strain coverage and reports influenza A, influenza B, RSV A and RSV B viruses separately.

Using state-of-the-art sample processing controls, the device accepts samples such as nasopharyngeal swabs, nasopharyngeal aspirates (NPA) and nasal and throat swabs. GenomEra Flu A/B + RSV testing is performed directly from transport media without RNA extraction to enable POC use.

Gastrointestinal infection diagnostics device

GenomEra Norovirus is one of the fastest tests for the detection and separation of GI and GII norovirus directly from stool samples. Norovirus is one of the most common causes of viral gastroenteritis globally. It spreads easily and effective control actions are essential to prevent epidemics. With minimal hands-on-time, GenomEra Norovirus’ results are available in around one hour.

GenomEra C. difficile is a direct stool test for detecting toxigenic Clostridium difficile, a leading cause for antibiotic-associated diarrhoea. The test targets the tcdB-gene found in a wide range of toxigenic Clostridium difficile strains to enable reliable and fast detection.

Assay kit for MRSA prevention and control

Abacus offers a comprehensive solution for the screening and diagnosis of methicillin-resistant Staphylococcus aureus (MRSA). This GenomEra MRSA/SA Multi Swab assay kit is intended for high-sensitivity screening of MRSA and Staphylococcus aureus from swab samples.

To achieve maximal sensitivity and ensure that no carrier is missed, the test uses three different swabs taken from nasal, throat and groin or perineum. The kit provides results within an hour.

Abacus also offers a solution for the detection of MRSA and Staphylococcus aureus from culture plates and directly from positive blood culture. MRSA/SA AC targets the conserved genetic region of Staphylococcus aureus and also has separate amplicons for the mecA and mecC genes. This approach allows a greater strain coverage than assays targeting the orfX-junction.

Screening programmes for newborn infections

Abacus’ GenomEra S. pneumoniae test provides automated detection of Streptococcus pneumoniae from positive blood cultures. This bacterium commonly causes blood poisoning for infants and the elderly.

Approximately 10%-30% of pregnant women are colonised with Group B Streptococcus (GBS). During labour, GBS can cause early onset group B streptococcal disease (EOGBSD) in newborn babies. GBS diseases can be prevented by antibiotic prophylaxis. The GenomEra GBS test can be performed during pregnancy or in the intrapartum period.