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ChromaCode has launched the HDPCR SARS-CoV-2 real-time PCR assay for the diagnosis of coronavirus (Covid-19) SARS-CoV-2 from NP swab specimens.
The test has been launched in accordance with the US Food and Drug Administration’s (FDA) review for emergency use authorisation (EUA). While an independent review of the validation data by the FDA is pending, the assay has been validated by ChromaCode.
ChromaCode claims that the assay can run over 1,000 samples per qPCR instrument. It uses Applied Biosystems 7500 Fast and QuantStudio 7 with no software or hardware updates.
The results from HDPCR SARS-CoV-2 are analysed on ChromaCode’s HIPAA-compliant cloud-based software named ChromaCode Cloud.
The software enables laboratories to streamline test workflow. It will also help in reducing the complexity of results interpretation.
ChromaCode co-founder, president and CEO Greg Gosch said: “We are excited to be offering a higher-throughput PCR test to support the SARS CoV-2 testing needs of hospitals and clinical reference labs.
“I am grateful to the entire ChromaCode team for quickly marshalling efforts to meet the extraordinary demands of the Covid-19 pandemic.”
HDPCR SARS-CoV-2 assay is said to increase throughput by three times and consolidates Centers for Disease Control and Prevention’s 2019-Novel Coronavirus Real-Time Reverse Transcriptase PCR Diagnostic Panel into a single reaction well.
The High-Definition PCR combines low-cost chemistries with ChromaCode’s proprietary data science algorithms. It seamlessly integrates onto common real-time and digital PCR platforms.
In addition, the Covid-19 diagnosis test enables the development of advanced multiplexing levels without any hardware changes.