The next generation in diagnostic testing is here. The Accula™ System is a sample-to-answer nucleic acid PCR amplification platform solution for the point-of-care (POC) with the simplicity, convenience and procedural familiarity of traditional rapid immunoassays. This patented system provides actionable, laboratory-quality results at POC with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. The Accula Flu A/Flu B and the Accula RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the US Food and Drug Administration (FDA).
The system is comprised of a palm-sized dock with single-use cassettes.
The small, bench-top Accula Dock controls reaction temperatures, timing, and fluid movements within the Accula Test Cassettes resulting in a is a sample-to-answer and automated assay.
The palm-sized Dock requires no maintenance or calibration. Installation is simple and the Dock can run any assay in the system.
Accula Flu A/Flu B Test Cassette
Influenza (flu) is a contagious respiratory illness caused by influenza viruses. It can cause mild to severe illness. Serious outcomes of flu infection can result in hospitalization or death. The FDA cleared, CLIA Waived and CE-marked Accula Flu A/Flu B Test is a is a sample-to-answer molecular diagnostic test utilizing polymerase chain reaction (PCR) technology providing accurate results for early diagnosis and proper management of influenza.
The Accula Flu A/Flu B test is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient.
Accula RSV Test Cassette
RSV is a common respiratory virus that can lead to serious health problems in infants and older adults. RSV can be dangerous for some infants and young children. Each year in the United States, an estimated 57,000 children younger than 5 years old are hospitalized due to RSV infection. The FDA cleared, CLIA Waived and CE-marked Accula RSV Test is a is a sample-to-answer molecular diagnostic test utilizing polymerase chain reaction (PCR) technology that provides accurate fast results for early diagnosis and proper management of respiratory syncytial virus (RSV).