2.2 05/2008, version 1.0
Roche-Manufactured External Controls (RMECs)
Each batch requires Roche-manufactured external controls (RMECs).
The number of RMECs required is test-specific.
MPX testing encompasses five analytes. Five positive RMECs plus one
negative RMEC must be pipetted for each batch. During pipetting, an
aliquot of the negative control is transferred to the S-tube in position 19 of
each SK24 rack. Then, aliquots from each positive control are transferred
to S-tubes in positions 20 through 24 of each SK24 rack (Figure 2.2).
WNV testing encompasses a single analyte. One negative RMEC and one
positive RMEC must be pipetted for each batch. During pipetting, an
aliquot of the negative control is transferred to the S-tube in position 23 of
each SK24 rack. Then an aliquot of the positive control is mixed with a
second aliquot of the negative control (obtained from a second tube of
negative control to dilute the positive control) in the S-tube in position 24
of each SK24 rack (Figure 2.3).
Pipetting of RMECs always occurs before sample pipetting. This
allows the operator to correct any control pipetting errors before
sample pipetting begins.
RMECs are always placed in the last positions in each SK24 rack so
that the entire testing process, from sample preparation through
amplification and detection, is monitored by control samples.
Figure 2.2
MPX RMECs in an SK24 Rack
Negative
Positive
Controls
Control
Figure 2.3
WNV RMECs in an SK24 Rack
Negative
Positive
Control
Control