NAT and ELISA in one room

[khalidm3]

At our center we face shortage of area to bring virology marker testing under the same roof. At present we have unsuitable room in other corner of building having no direct passage. We transport samples there.

We have sufficient place in our NAT testing room. At present we test our donors for Nat by Hamilton MICROLABSTAR/COBAS TAGMAN/COBAS AMPLIPREP.

The Cobas Local distributor is rising official objection to install any machine there; open system or closed other than their machines. They claim ELISA testing in the same area shall cause contamination and give false positive results

Can we place there open system ELISA or Closed one.

[David Saikin]

Many of the newer amplification technologies do not require "clean" rooms. Check the manufacturer's procedure . . . since you are FDA licensed (I assume), you will need to comply with that document unless you perform some very stringent validation studies. You would probably be wise to contact the agency (your consumer rep) and discuss it with them prior to altering any manufacturing processes. It would be unfortunate if you had to "recall" all your products which were tested by a non-conforming method.

Duh - I see you are in the Kingdom - What is their official policy? Are you governed by FDA at all? You will need to comply with your governmental regulations/manufacturer's directions.

[khalidm3]

Thanks David, I am in Riyadh, kingdom of Saudi Arabia. Here we are ruled by MOH. Recently they have established Saudi FDA, We have Saudi Board for heath care institutions accreditation, saudi council for health specialities.MOH usually gets guide lines from US FDA/CAP/AABB. In my town we have some hospitals JCI/CAP/AABB accredited. Our Centre is going for Joint Commission International during 2011, November 2011 is our final inspection month. Hope soon we shall go for CAP and AABB also.

I appreciate ur advice we shall follow it.