External Quality Controls for Molecular biology...

External Quality Controls for Molecular biology laboratory applications

An Italian SME has developed a series of External Quality Control
programmes for molecular diagnostics.
All programmes are certified and all focus on quality control of the extremely delicate laboratory applications within the field of molecular diagnostics,
and more specifically, in the microbiology, oncology and genetic
sectors. The company is looking for joint venture agreements and
commercial agreements with technical assistance.

An Italian company has developed some External Quality Control programmes for molecular diagnostics. These programmes are certified and fall under the patronage of different scientific societies and universities. The programmes focus all on quality control of the extremely delicate laboratory applications within the field of molecular diagnostics, and more specifically in the microbiology and virology: nucleic acid extraction from biological matrices, amplification of specific targets and their detection on gel, on microplates or microchips and in Real Time PCR (polymerase chain reaction).
The programmes have been designed to precisely evaluate the performance of the single laboratories and make it possible to compare the results of each single laboratory with the performance of the other participating laboratories. Some specified applications can be jointly produced or developed within the technical cooperation foreseen.

Programmes based on screening for HPV (human papilloma virus) infection are particularly interesting, not only for the availability of the different genotypes (HPV-16, 18, 30, 31, 35, 42, 45, 51, 54, 56, 58, 59, 73) but also because the controls contain both the L1, that characterizes the viral type, and the E6/E7 regions involved in tumoral transformation of the cell.

The scientific community considers the E6/E7 regions to be the most
reliable target for screening of carcinoma of the uterine cervix since the virus may integrate within cells and lose all or part of the L1 region. Other programmes cover Herpesviridae infections such as CMV(Cyto-Megalo Virus), EBV (Epstein-Barr Virus), HSV (Herpes Simplex Virus) 1 and HSV2.

One-tube PCR internal controls containing sequences of HBV (Hepatitis B Virus), HCV (Hepatitis C Virus) or CMV, are currently
available.

Innovative Aspects:
The company offers a series of External Quality Control programmes all of which employ a panel of cloned positive controls containing different sequences.
These positive controls can find application in a variety of assays and/or diagnostic protocols. In some cases, the positive controls may contain sequences that compete with the test target sequence during amplification. Such controls can be used for internal reaction control or to monitor the entire diagnostic process starting from the phase of extraction.

Availablefordemonstration

SecretKnowhow

Recombinant DNA
Other diagnostic

11-50

Joint venture agreement, Technical cooperation agreement