Technical considerations for the performance of Nucleic acid Amplification Technology (NAT). The NAT Task Force Group.
The complexity of Nucleic acid Amplification Technology (NAT(1)), comprising sample preparation, amplification and detection methods, requires specific design considerations for both the laboratory and the procedures utilized in such testing. The purpose of this paper is to establish technical considerations for the performance of NAT. These include the collection, handling and assay of specimens and the design of laboratories to routinely and reliably detect low levels of nucleic acid sequences. The sensitivity of NAT due to the exponential amplification of nucleic acids makes contamination a major concern from specimen collection to sample detection. Therefore, laboratories need to be designed to prevent and control contamination through adequate equipment and appropriate workflow. These technical considerations should provide a basis for establishing a robust and reproducible NAT system.
Chudy
Michael
M
Paul-Ehrlich-Institut, Germany.
Hewlett
Indira
I
Saldanha
John
J
Bianco
Celso
C
Conrad
Andrew J
AJ
Gierman
Todd
T
Heldebrant
Charles
C
Rautmann
Guy G
GG
Roth
W Kurt
WK
Stramer
Susan
S
Weimer
Thomas
T
Whitaker
Barbee
B
Zerlauth
Gerold
G
D006801:Humans; D007318:Inservice Training; D025202:Molecular Diagnostic Techniques / Q000592:standards; D021141:Nucleic Acid Amplification Techniques / Q000379:methods / Q000592:standards; D013048:Specimen Handling / Q000592:standards; D013223:Statistics as Topic / Q000379:methods / Q000592:standards