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MULTICENTRE
STUDIES
THE STANDARDIZATION
PROJECT WITH THE DIAGNOSTIC COMPANIES
COORDINATORS
Meroni P.L.,
Cruini C., Pregnolato F., * Malacarne F., *Tincani A.
Clin Immunol Unit, IRCCS Ist. Auxologico I., University of Milan; *Rheumatology and Clinical
Immunology, Spedali Civili, Brescia - Italy
PROJECT
Antiphospholipid
ELISAs are part of the Antiphospholipid Antibodies Syndrome classification criteria, having comparable diagnostic value as lupus anticoagulant.
Minimal requirements have been identified at the European level to decrease the
inter-laboratory variability. During the IVth aPL European Forum
Meeting (London, 16-17 January 2004), the minimal requirements were presented
to the companies producing kits for the 2 assays and attending the meeting.
Upon a proposition from Marie-Claire Boffa, the Standardization Committee
invited 17 Companies producing aCL and anti-b2GPI immunoassays to an
interactive workshop that was held the 3rd of May
2004 in Milan, Italy.
The
Standardization Committee presented “proposals” derived from the “minimal
requirements”:
- to
calculate the cut-off in percentiles was the first proposal;
- the
possibility to use a semiquantitave (high, medium, low, negative) measurement
was also discussed;
-
external reference were proposed.
One
Company presented a new generation assay for aCL based on the minimal
requirements proposed by the Standardization Committee. Interestingly the kit uses a mixture of human and bovine -β2GPI.
Selected
samples have been tested with the commercial kit and with aCL home-made assays
carried out in two different reference centers. Preliminary results showed a
good reproducibility; a high sensitivity was also noted and related to the
ability of detecting aPL with specificity for human β2GPI that are not recognized by
standard aCL assays employing the bovine molecule.
For additional
information and applications, please e-mail: pierluigi.meroni@unimi.it
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Last updated: 17 November 2005 |
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