only test on cdc list., page-2

The best result that CST could obtain is to have QF-Gold approved by the FDA/CDC as a standalone alternative to the Mantoux test.

CDC are putting on a staff member to co-ordinate field trials for QF - Gold. The supplementary application to the FDA seems to be on the 180 day track. This points to a positive outcome in the US in 2004.

CST has to have approval in US/Japan + Europe as they control the funding bodies that approve funds for TB testing and subsequent treatment in third world countries where TB is prevelant.

To clarify the 12 hour and three week testing periods.

The whole blood sample when harvested contains full strength interferon levels. This level falls over time and statistically the required levels for testing are still high enough in 12 - 16 hours from harvest. The FDA has been conservative and selected 12 hours as the cut-off.

However, a technician could apply three drops of a fixer to the whole blood sample, incubate it and decant the plasma fron the top of the tube [white cell] and leave the red blood component at the bottom. This plasma can be stored in a fridge for three weeks before testing or if frozen indefinitely stored.

This procedure will be useful in the third world as a technician + nurse can travel to villages take a lot of samples say over a week, treat them to recover plasma [ within the 12 hour window], store them and then bring them back to a lab.

Approval and then acceptance by the medical profession so sales ensue is a tortuous process. It takes time and money and most fail.

I believe CST is entering the stadium nearing the end of its marathon - this year CST should be running past the stands.