Normal Clinical Matrix is derived from anterior nasal swab samples diluted into either UTM, VTM, or Saline solution. Samples are collected from IRB-approved and consented healthy donors in an FDA-registered facility. All donors are screened negative for FDA transfusion markers using FDA-cleared test methods. Donor material is then pooled and stored frozen to the volumes listed below. Normal Clinical Matrix is used to support your analytical studies. It may be used to titrate markers for determination of assay LOD and sample recovery, evaluation of assay precision, and other validation studies to support your regulatory submissions. This product is intended for research and development use and should not be used for clinical diagnostic purposes. Biosafety Level 1: The materials used to formulate this product contain no infectious material that pose hazard to laboratory personnel and the environment. All donors are screened negative for FDA-required viral markers using FDA-cleared test methods; however, all materials should be considered potentially infectious and handled with universal precautions.

Product Insert.pdf