Bio-Rad Launches Synthetic Negative and HAI Negative Run Controls

Bio-Rad Laboratories (Hercules, CA, USA) 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. Both 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 nine 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. Both products are designed to save laboratories the time and costs associated with the labor-intensive screening, qualification, manufacturing and maintenance of clinical specimens that would otherwise be used as controls.

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