EQC - Program
The EQC Program for molecular diagnosis is articulated at two levels: Level 1 and Level 2
LEVEL 1
This level has been designed to evaluate qualitative efficacy starting from a specific biological matrix and eventual carry-over phenomena during the following processes:
- DNA Extraction
- PCR amplification
- Agarose gel electrophoresis
The participating laboratory will receive the Quality Control kit (L1) from bcs Biotech srl with the following components:
- 2 vials containing 5 μl of positive samples and 2 vials containing negative samples labelled in an anonymous fashion
- 4 vials containing the primers
- 1 vial containing the molecular weight marker
- 2 vials containing a negative and a positive control
- User’s Guide
- A Form, that must be compiled in full and returned to the Reference Center within 15 days of receiving the Kit, together with the following attachments: the extraction protocol (only if home-made) and the agarose gel photos.
Based on the data supplied by BCS and confirmed by the CR, the CeSI (Reference Centre-RC), will analyze the results within 30 days of receiving the Form, and will send a Scheme with the following information for each analyzed sample to each participating lab: a) the result obtained by the laboratory and the expected result, b) the mean results obtained by all participating laboratories for that specific sample, c) the mean results obtained by laboratories using the same analytical method.
At the end of each EQC cycle the participating laboratory will receive a Form containing a “performance score” with respect to all the other participating laboratories.
LEVEL 2
This level is for Molecular Medicine laboratories that operate in specific sectors and offers a variety of applications including hematologic viruses and a broad spectrum of human papilloma viruses. The scope of this level is to evaluate the qualitative efficacy (specificity) and the semiquantitative and/or quantitative efficacy /sensitivity) of diagnostic user protocols.
In order to participate to Level 2 of the EQC Program, it is essential that laboratories check the compatibility of the primers and probes used in their in-house diagnostic methods with the cloned sequences included in the different EQC programs supplied by BCS (see the information supplied under “EQC applications”. When you apply for participation to the EQC Program you will be required to send us a declaration that you have checked compatibility.
Level 2 of the EQC Program is articulated in two distinct phases:
Phase 2A qualitative
The participating laboratory will receive a kit from bcs Biotech srl with the following components:
- 5 vials containing 5 μl of positive control and 5
- 5 vials of the negative control which may be positive for other targets
- A Form, that must be compiled in full and sent back to the Reference Center within 15 days of receiving the kit, together with the user protocol and other documentation of the results obtained.
Based on the data supplied by BCS and confirmed by the CR, the CeSI (Reference Centre-RC), will analyze the results within 30 days of receiving the Form, and will send a Scheme to each participating lab with the following information for each analyzed sample: a) the result obtained by the laboratory and the expected result, b) the mean results obtained by all participating laboratories for that specific sample, c) the mean results obtained by laboratories using the same analytical method.
At the end of each EQC cycle the participating laboratory will receive a Form containing a “performance score” with respect to all the other participating laboratories.
Phase 2B semiquantitative
The participating laboratory will receive a kit from bcs Biotech srl with the following components:
- 4 vials containing 5 μl scaling dilutions of the positive control and 4 vials of the negative control that may be positive for other targets
- A Form, that must be compiled in full and sent back to the Reference Center within 15 days of receiving the kit together with the user protocol and other documentation of the results obtained.
Based on the data supplied by BCS and the standard curve of the RC, the CeSI (Reference Centre-RC), will analyze the results within 30 days of receiving the Form and will send a Scheme to each participating lab containing the following information for each analyzed sample: a) the result obtained by the laboratory and the expected result, b) the mean results obtained by all participating laboratories for that specific sample, c) the mean results obtained by laboratories using the same analytical method.
At the end of each EQC cycle the participating laboratory will receive a Form containing a “performance score” with respect to all the other participating laboratories.
