Description
INTENDED USE:
The Exact Diagnostics Bulk CSF Negative is an independent external quality run control intended to monitor the absence of Anaplasma phagocytophilum, Babesia microti, Bartonella quintana, Borrelia burgdorferi, Ehrlichia chaffeensis, Enterovirus (EV), Herpes Simplex Virus-1 (HSV1), Herpes Simplex Virus-2 (HSV-2), and Varicella Zoster Virus (VZV) in various molecular assays.
This product can be used to detect errors in laboratory testing procedures, including potential contamination events.
This product also allows laboratories to evaluate their molecular assay and test for operator proficiency.
This product may be utilized to dilute cerebrospinal fluid (CSF) specimens or to spike-in specimens that are in matrices other than CSF.
PRODUCT DESCRIPTION:
The Exact Diagnostic Bulk CSF Negative is a synthetically formulated CSF (cerebrospinal fluid) matrix intended to simulate negative patient specimens for the purpose of testing the entire process of a molecular assay including extraction, amplification and detection. This product is non-reactive for Anaplasma phagocytophilum DNA, Babesia microti DNA, Bartonella quintana DNA, Borrelia burgdorferi DNA, Ehrlichia chaffeensis DNA, Enterovirus RNA, Herpes Simplex Virus-1 DNA, Herpes Simplex Virus-2 DNA and Varicella Zoster Virus DNA.
LIMITATIONS:
For In Vitro Diagnostic Use.
