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WHY 100% REAL?

UTAK 100% REAL human matrices yield predictable, consistent results.  Though we knew that using a 100% REAL Human matrices for our products presented challenges to manufacturing, we understood, that with Laboratory Testing, there is no more appropriate solution for improved patient care and outcomes than a Quality Control Matrix that mimics the patient specimen.

According to the International Organization for Standardization, the (ISO) Standard regarding Quality Control Materials for Laboratories, ISO 15189, Section 5.6.2.2 states;

  • The laboratory shall use quality control materials that react to the examining system in a manner as close as
  • Quality control materials shall be periodically examined with a frequency that is based on the stability of the possible to patient samples. procedure and the risk of harm to the patient from an erroneous result.

NOTE 1 The laboratory should choose concentrations of control materials, wherever possible, especially at or near clinical                     decision values, which ensure the validity of decisions made.

NOTE 2 Use of independent third party control materials should be considered, either instead of, or in addition to, any                            control materials supplied by the reagent or instrument manufacturer.

Our 100% REAL Serum, Urine, and Whole Blood bulk matrices and Quality Control Products are manufactured to mimic the patient specimen. These products will also are support your compliance with the ISO 15189 and other Regulatory and Lab Accreditation standards.

The Control Freaks have but one focus, and that is the customer. Seeking and identifying Laboratories and Laboratorians that we can work with and manufacture Bulk Matrices, Specialty Matrices, and Quality Control products to support quality control and method development activities.

When accuracy matters, create CONTROL.