Standard Operating Procedure

Subject Cobas E411 Immunoassay System Routine Operation

Index Number Lab-1599
Section Laboratory
Subsection Regional/Affiliates
Category Departmental
Contact Rachel Blum
Last Revised 5/1/2018

References
Required document for Laboratory Accreditation by the College of American Pathologists (CAP), Centers
for Medicare and Medicaid Services (CMS), COLA and/or CLIA.

Applicable To
Employees of the Gundersen Health System Laboratories, Gundersen Tri-County Hospital laboratories,
Gundersen St. Joseph’s Health Services laboratories and Gundersen Boscobel Area Hospital laboratories
and Gundersen Palmer Lutheran Hospitals and Clinics laboratory.

Detail
The Roche Diagnostic cobas e411 Immunoassay System is a fully automated, random access, software-
controlled system for immunoassay analysis. Three test principles are available on the system:
competitive principle for extremely small analytes, sandwich principle (one or two steps) for larger
analytes and a bridging principle to detect antibodies in the sample.

The cobas e411 automates the immunoassay reactions utilizing electrochemiluminescence (ECL). ECL is
a process in which highly reactive species are generated from stable precursors at the surface of an
electrode. These highly reactive species react with one another, producing light.

The development of ECL immunoassays is based on the use of a ruthenium (II)-tris(bipyridyl)[Ru(bpy)]

complex and tripropylamine (TPA). The final chemiluminescent product is formed during the detection
step.

The chemiluminescent reactions that lead to the emission of light from the ruthenium complex are
initiated electrically by applying voltage to the immunological complexes that are attached to the
streptavidin-coated microparticles.

Implementation
PROCEDURE:
Turn front switch on analyzer to OFF position before doing maintenance procedures in the morning.
1. Remove reagent compartment lid and reagent wheel to check for condensation inside. Wipe out
any moisture. Replace wheel, replace lid.
2. Clean S/R probe with distilled H2O on gauze, and then dry gauze. Use 70% Isopropanol when
probe is visibly dirty.

Turn front switch to ON position. When analyzer has returned to standby, proceed with the following:
1. Check Inventory:

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 Standard Operating Procedure

a. Each test reagent cartridge is displayed with # of tests and position #. Additional
cartridges to be added should warm >45 minutes prior to loading.
b. Check for sample tips and cups. Do not add to partial racks.
c. Replace ProCell/Clean Cell if less than 20%. Move full bottles from left side to right and
load new bottles on left.
d. Empty waste containers.
e. Check volume of System Water.
f. Do a ‘clear sample data’ from the Overview screen.
2. Calibrate: Refer to “Calset calibration Instructions” for handling of calibrator. Confirm lot
number by checking Calibration, Calibrator, and Test. If lot number is not on this screen, go to
Install tab, insert card in slot and select BC Card Scan.
a. Allow calibrator vials to warm ~15 minutes before loading.
b. Load on ring aligning the slight extension on the rim of the calibrator vial with the notch
in the hole on the ring. Open caps to 90o angle.
c. Press START on keyboard. e411 will read barcodes on vials and perform calibration for
that test.
3. To Run QC:
a. (If running behind calibrators, leave a space open before inserting controls.) Allow
calibrator vials to warm to room temperature before loading.
b. Allow control cups to warm 15 minutes before loading. Replace ring with sample disk.
c. Load control cups on ring. Manually program by selecting QC from Overview screen,
then Control, Position Assignment, and select control and position, then assign.
d. Controls are identified by letter and are poured into large Hitachi cups.
e. Press START on right side of screen and START on the START screen.
f. Be sure to unassign positions for QC after running QC, so other samples may be run in
those same positions. From Overview screen, select QC, Control, and Position
Assignment; then, select control, position, and remove.
4. Standby reagent packs:
a. Place new reagent pack on e411, do a reagent scan.
b. Calibrate all new packs. To program calibration, from Overview screen, touch
Calibration, status, highlight standby, select manual, save. Check on system overview to
see if done correctly. Allow controls to warm to room temperature before loading.
c. Replace ring with sample disk.
5. To run QC on standby pack, go to QC, status, standby bottle QC, check box, OK. Check on system
overview to see if done correctly.
6. Place tube(s) in sample disk, barcodes facing out. Press START, and then START.
7. To run a STAT sample, if e411 disk is currently sampling other specimens, touch Work Place, Test
Selection, Stat (E), type in position #, and test(s). Place tube in proper position (bar code facing
out) and touch Save. Touch Stat mode on right side of screen, START and START. Return to home
screen and Sample Tracking to make sure sample was programmed in as STAT.
8. If disk is in S. Stop, samples can be added by starting at the STOP tube. Place new ones in sample
disk, bar codes facing out. Touch START and START.
9. Directions to print out selected reports when interface is down.
a. If the interface goes down, the instrument must be in STANDBY.

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 Standard Operating Procedure

b. Go to Workplace, data review. Select data by clicking on what samples you want to print
or do a sample range start and end. Click on Print, highlight result report, click on print,
printout.
10. Directions for Retransmission of cobas e411 results
a. To retransmit specimens when the interface was down once the interface comes back
up:
11. Go to Workplace, Data review, select sample, sample range start, click on last sample, click on
sample range end.
12. To delete samples one at a time, from data review screen select samples, delete record.
13. After transmitting the test to the host
Go to Utility, page 2, Documentation setup, upload, ok.
Refer to Roche Diagnostics cobas e411 System Operator’s Manual for detailed instruction.

REVIEW AND CHANGES:

This document and all attached forms should be reviewed optimally on an annual basis, with 2 years as
the maximum review date. Review will be done by the Supervisor, Manager, Technical Leader, Medical
Director or designated person. Changes require retyping document or form and review by the Medical
Director.

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