Bio-Rad Laboratories has expanded its molecular offering of quality controls with the launch of two new Exact Diagnostics products: Synthetic Negative Run Control, which complements the Tick-borne, Meningitis/Encephalitis and Sexually Transmitted Infections products; and HAI Negative Run Control, which complements the Hospital-Associated Infections products, according to a news release.
Both products are external quality controls designed to be used with molecular assays to monitor their intra- and inter-run performance. These products may also be used for dilution or spike-in purposes such as assay validation and verification.
The Exact Diagnostics Synthetic Negative Run Control is screened negative for 9 targets: Anaplasma phagocytophilum, Babesia microti, Bartonella quintana, Borrelia burgdorferi, Ehrlichia chaffeensis, Enterovirus (EV) Coxsackievirus A9, Herpes Simplex Virus-1 (HSV-1), Herpes Simplex Virus-2 (HSV-2), and Varicella Zoster Virus (VZV).
The Exact Diagnostics HAI Negative Run Control is screened negative for 3 targets: Clostridium (Clostridioides) difficile, Methicillin-resistant Staphylococcus aureus (MRSA), and Methicillin-susceptible Staphylococcus aureus (MSSA).
These products enable laboratories to capture run-to-run, day-to-day, instrument-to-instrument, operator-to-operator, and lot-to-lot variations of their molecular assays. They can also be used to train laboratory operators and evaluate proficiency. Another application is the spike-in and dilution of positive specimens or analyte-containing materials for assay validation and verification.