Overview
Independent external quality run control to monitor the absence of Adenovirus (ADV), BK virus (BKV), Candida auris (C. auris), Chlamydia trachomatis (CT), Cytomegalovirus (CMV), John Cunningham virus (JCV), Mycoplasma genitalium (MG), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Zika virus (ZKV) in various molecular assays. (1x 50 mL)
Safety Data Sheet
Description
Description
INTENDED USE:
The Exact Diagnostics Bulk Urine Negative is intended to be validated as an independent external quality run control to monitor the absence of Adenovirus (ADV), BK virus (BKV), Candida auris (C. auris), Chlamydia trachomatis (CT), Cytomegalovirus (CMV), John Cunningham virus (JCV), Mycoplasma genitalium (MG), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Zika virus (ZKV) 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 urine specimens or to spike-in specimens that are in matrices other than urine.
PRODUCT DESCRIPTION:
The Exact Diagnostics Bulk Urine Negative consists of pooled human urine and intends 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 Adenovirus DNA, BKV DNA, Candida auris DNA, Chlamydia trachomatis DNA, CMV DNA, JC virus DNA, Mycoplasma genitalium DNA, Neisseria gonorrhoeae DNA, Trichomonas vaginalis DNA and Zika virus RNA.
LIMITATIONS:
For Research Use Only (not for use in diagnostic procedures).