SVLTest, Standard for Laboratory Verification of Legipid® (Ref. No. 311-30-SV)
The UNE-EN ISO/IEC 17025, 2017 standard says that "the laboratory must verify that it can properly carry out the methods before using them, ensuring that it can achieve the required performance." The Legipid® test is a method already validated by the competent international organization AOAC-RI and the user is only responsible for providing "objective evidence" that it is suitable for the "intended use" (verification).
SVLTest, Legipid® Standard for Laboratory Verification (Ref. No. 311-30-SV) is a simple and fast system for the laboratory to verify its performance with the Legipid® test. It provides materials, protocol, and a spreadsheet, to carry out the verification by determining the operational characteristics of the test (accuracy, recovery, uncertainty).
Reference 311-30-SV contains 10 vials per level (high, medium, low) with a volume of 0.6 mL/vial of a frozen suspension of a known concentration of Legionella Log10UFCeq and a bottle of L0 with a volume of 300 mL.
Once received, the vials should be immediately stored at -20 °C and the L0 reagent bottle in the refrigerator at 5±3 °C. The expiration of the material, properly stored, is 3 months from the date of supply. Each set of vials per level is labeled with its batch number and storage conditions. In addition, the protocol includes code, batch number and expiration, which guarantees traceability.
Ask us for the excel sheet to calculate the verification parameters.