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PURPOSE:
The DCA 2000 Analyzer quantitatively measures the percent concentration of
Hemoglobin A1c in blood. The measurement of hemoglobin A1c concentration is
recommended for monitoring the long-term care of persons with diabetes. This procedure
has been prepared for the University Hospitals (UUHSC) and Clinics.
PRINCIPLE:
The DCA 2000 uses an immunochemical method for the measurement of HbA1c,
employing a monoclonal antibody which recognizes the glycated N-terminus of the β
chain of hemoglobin. The antibody does not bind to hemoglobins glycated at other
positions, because both glucose and the specific amino acid sequences must be present for
binding. An agglutinator, present as one of the reagents, causes agglutination of specific
anti-HbA1c coated latex particles. This is measured as an increase in turbidity by the
spectrophotometer. Patient’s sample HbA1c, bound to the HbA1c coated particles, causes
an inhibition of the agglutination in proportion to its concentration in the blood. This is
quantified by comparison to a lot specific calibration curve whose parameters are
contained in the instrument software. The final concentration is calculated as a ratio of
HbA1c to total hemoglobin, previously determined as methemoglobin using a
ferrocyanide reaction.
SCOPE:
This procedure applies to medical personnel performing waived HbA1c testing in the
University Hospitals (UUHSC) and Clinics. Personnel performing waived HbA1c testing
may perform this procedure if previously trained by the ARUP/University Hospital Point
of Care Department.
PERSONAL PROTECTIVE EQUIPMENT:
Performance of this procedure will expose testing personnel to biohazardous material and
possible chemical hazards.
This procedure may expose you to:
[X] Bloodborne pathogens
To perform this procedure, you must use:
[X] Gloves
[X] Protective Clothing (scrubs, lab coats..)
Disinfect following procedure:
[X] Sodium Hypochlorite, (Diluted bleach)- a 10% solution made fresh daily
References for spill/decontamination:
[X] MSDS
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SPECIMEN COLLECTION:
Collect: Whole blood using established capillary technique.
Acceptable: Capillary blood.
Unacceptable: Non-capillary sample.
Stability: Capillary samples cannot be stored.
REAGENTS AND EQUIPMENT:
NOTE: Make sure to label any reagents/controls with the open date and operator
initials.
1. DCA 2000 Analyzer
2. Reagent Kit:
a) Reagent Cartridges
b) Capillary Holders
c) Calibration Card
i. Upon receipt of the kit, check the temperature indicator located on the front of
the carton. If the indicator has turned red, the reagent cartridges should not be
used. Record the received date on the carton.
ii. Store cartridges refrigerated (2-8˚ C) until expiration dated on kit. Capillary
holders may be stored refrigerated or at room temperature (15-30˚ C).
iii. Cartridges may be stored at room temperature for up to three months (before the
expiration date). Record on the carton, the date the carton was placed at room
temperature.
3. DCA 2000 Controls:
a) Normal control / Abnormal Control / Reconstitution Fluid
b) Eyedropper Cap Assemblies
c) Control Card (double sided)
i. Unreconstituted controls: should be stored 2-8˚ C or –20˚ C. Stable until the last
day of the expiration month shown on the bottle.
(see Quality Control:, Reconstituting the control vial.)
Note: Appearance of moisture in the bottle, prior to reconstitution, is an indication of
deterioration of the material. The control should not be used. Control solution
appearing turbid or obviously contaminated should be discarded.
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ii. Reconstituted controls: Should not be frozen. Control material may remain at
room temperature for 30 minutes during testing, but should be stored
refrigerated, upright and tightly capped at all other times.
iii. Reconstituted controls are stable for 3 months refrigerated.
4. Optical Test Cartridge
a) Run initially when instrument is first installed.
b) Quarterly.
c) After cleaning the cartridge compartment.
d) After changing the air filter.
e) When Customer Service instructs you to.
CALIBRATION:
Initially the manufacturer performs the calibration and thereafter the instrument selfadjusts upon power-up and during each assay.
1. A calibration card is placed in each new box of reagent cartridges with values of the
calibration parameters. The calibration for the reagent cartridges is encoded onto the
card.
2. Prior to using the lot of reagent cartridges, the calibration card is scanned into the
instrument.
3. Also, before a sample can be analyzed, the reagent cartridge bar code is scanned by
the instrument. This accesses the appropriate calibration parameter values (calibration
curve), previously scanned into the instrument for that particular lot number of
reagent cartridges in use.
Scanning the Calibration Card:
1. Locate the dot (on the instrument) next to the bar code track.
2. Locate the bar code on the calibration card.
3. Hold the card so that the bar code faces right.
4. Insert the card into the bar code track (above dot). Hold card gently against the right
side of track.
5. Quickly (within 1 second), and smoothly slide the card down past the dot. A beep will
sound to signal a successful scan.
Note: If no beep sounds, repeat procedure. If a beep repeatedly fails to sound, call the
Teaching Assistant at pager 339-5487.
QUALITY CONTROL:
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Run both DCA controls, (one normal and one abnormal) on each analyzer:
 Daily (each day of patient testing)
 With each new shipment of test kits.
 With each new lot of test kits.
 Each time a calibration card is scanned.
 Anytime an unexpected result is obtained.
Reconstituting the control vial:
1. Remove the control bottles from the refrigerator just prior to reconstitution.
2. Gently tap the bottom of the control bottle.
3. Carefully remove the cap from the control bottle.
4. Add six drops of reconstituting fluid to the control bottle.
5. Replace the cap (not the eyedropper), and swirl the control bottle several times. Let
stand at room temperature for approximately 15 minutes.
6. After 15 minutes, coat all surfaces of the control bottle by rotating and inverting the
bottle. Continue mixing until the solution is reconstituted.
7. Remove and discard the cap, replace with the eyedropper cap.
Procedure for running control samples:
Obtain a capillary holder and remove it from the plastic wrap.
(Refer to PROCEDURE: Opening the Capillary Holder).
1. Remove a reagent cartridge from the foil wrapper, and label the cartridge with the
appropriate level of control to be tested. Scan the control card located in the control
box prior to scanning the reagent cartridge. (Refer to PROCEDURE: Opening the
Foil Package of the Reagent Cartridges).
2. Unscrew the Eyedropper Cap Assembly. While applying only slight pressure to the
bulb, insert the tip of the eye-dropper into the control solution (tilt bottle as necessary)
and release pressure on the bulb to aspirate a very small amount of control solution.
3. Hold the glass capillary tube to the control solution collected in the eye dropper and
completely fill the 1 µL tube. Touch ONLY the tip of the tube to the control solution.
If an air bubble is present in the filled tube, discard the capillary holder and refill a
new one.
4. Squeeze any excess control solution back into the control bottle. Replace the
eyedropper cap back onto the bottle.
5. Using a lint-free tissue, carefully wipe any control solution off the sides of the glass
capillary tube. DO NOT ALLOW THE TISSUE TO TOUCH THE OPEN END OF
THE TUBE. Contact with the open end of the capillary could result in loss of sample.
6. Insert the capillary holder into a DCA 2000 Hemoglobin A1c Reagent Cartridge until
the holder gently snaps into place.
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Scanning and Inserting the Reagent Cartridge:
1. Locate the dot (on the instrument) next to the bar code track.
2. Locate the bar code on the reagent cartridge.
3. Hold the cartridge so that the bar code faces right.
4. Insert the cartridge into the bar code track (above dot). Hold cartridge gently
against the right side of track.
5. Quickly (within 1 second), and smoothly slide the cartridge down past the dot. A
beep will sound to signal a successful scan.
6. Insert the reagent cartridge into the compartment until a subtle snap is heard / felt.
7. Pull the flexible plastic pull-tab completely out of the reagent cartridge.
8. Close door. Dispose of the flexible plastic pull-tab.
9. Following a six minute wait, the result will appear on the display screen. Record
the results on the either the DCA QC Log or DCA Result Log.
10. Remove the reagent cartridge and discard in appropriate bio-hazard container.
11. If the result is not within range from the values printed on the Normal and
Abnormal Control Kit Insert, rerun the control solution.
12. If the results remain outside the given range, check the reagent cartridge, control,
instrument and technique and rerun the control.
13. If results are still not within range, reconstitute new bottles of normal and
abnormal control solution and repeat steps 1-6.
14. If the result(s) continues to remain outside the given range, discontinue patient
testing and contact the Teaching Assistant at pager 339-5487.
15. Record any problems on the Corrective Action Log.
(Refer to: Procedure CN-QC6001).
PROCEDURE:
Opening the Foil Package of the Reagent Cartridges:
1. DO NOT USE SCISSORS
2. To open, tear down from corner notch (until entire long side of pouch is open).
a) Do not touch the optical window or erroneous test results may occur.
b) Discard the cartridge if it is damaged, the pull-tab is loose or missing, the
desiccant is missing, or if loose desiccant particles are found inside the foil pouch.
3. Allow the reagent cartridge to warm to room temperature (15-30˚ C), for
approximately 10 minutes.
Note: The cartridge must be used within one hour. Do not refrigerate the reagent
cartridge after the foil pouch has been opened.
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Opening the Capillary Holder:
Unused capillary holders may be saved and used with any lot of Hemoglobin A1c
Reagent Cartridges.
1. Open the plastic wrap by tearing wrap at serrated edge.
2. Inspect the capillary holder for the presence of :
a) Absorbent pad
b) Glass capillary
c) Latching mechanism
Note: If the capillary holder is missing any of the above parts, discard the capillary
holder.
Filling the capillary with a patient sample:
1. Hold the capillary holder at an angle.
2. Touch ONLY the tip of the capillary to a small drop of blood until the capillary is
filled.
3. Using a lint-free tissue, carefully wipe the outside of the glass capillary. Contact with
the open end of the capillary could result in loss of sample (by wicking into tissue). If
sample loss is obvious, discard capillary holder; then repeat procedure using a new
capillary holder.
4. Inspect the glass capillary for the presence of bubble(s). If bubbles are obvious,
discard the capillary holder, repeat with a new holder.
5. Position the capillary holder in the correct orientation for insertion into the reagent
cartridge. Insert the holder into the reagent cartridge until the holder gently snaps into
place.
6. Label the reagent cartridge with the patient’s name and date of birth or patient’s
medical record number. Do not obscure the bar code.
Analyzing the Patient Sample:
1. Locate the dot (on the instrument) next to the bar code track.
2. Locate the bar code on the reagent cartridge.
3. Hold the reagent cartridge so that the bar code faces right.
4. Insert the reagent cartridge (above dot) into bar code track.
5. Quickly (within 1 second) and smoothly, slide the reagent cartridge down past the dot.
A beep sounds to signal a successful scan.
6. Open the cartridge compartment door.
7. Hold the reagent cartridge so that the bar code faces right. Insert the reagent cartridge
into the compartment until a subtle snap is heard / felt.
8. Pull the flexible plastic pull-tab completely out of the reagent cartridge.
9. Close door. Dispose of the flexible plastic pull-tab.
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10. Record the displayed result on the DCA Result Log before removing the reagent
cartridge.
Removing the reagent cartridge.
1. Open the cartridge compartment door
2. Locate the button on the right side of the compartment. Push and hold it down
with your right hand.
3. With your left hand, gently push the plastic tab on the cartridge to the right; this
action releases the cartridge.
4. Pull the reagent cartridge out of the compartment and discard in appropriate biohazard container.
ERROR MESSAGES AND TROUBLESHOOTING:
Refer to the DCA 2000 Analyzer Operating Manual for a complete listing of error codes
and troubleshooting. Document all errors and corrective action on the corrective action
log (Refer to: Procedure CN-QC6001).
Call the Teaching Assistant at pager 339-5487 if any further help is needed.
DCA 2000 ANALYZER MAINTENANCE AND CLEANING:
Do not use sprays. Sprays will permanently damage the optical system.
Weekly:
Instrument Exterior / Bar Code Window.
1. Turn off the power and unplug the power cord.
2. Clean the exterior of the instrument, including the display panel and bar code window
with a lint-free cloth dampened with water. A cloth dampened with ethanol may also
be used
Note: Do not allow water or other cleaning fluid to drip inside instrument, bar code
window area or keypad area.
Quarterly:
Cartridge Compartment / Change Air Filter / Optical Test Cartridge
Refer to DCA 2000 Analyzer Operating Manual: Instrument Care and Routine
Maintenance section for complete instructions.
Procedure for Running Optical Test Cartridge:
1.
2.
3.
4.
Locate the bar code on the optical test cartridge.
Hold the cartridge so that the bar code faces right.
Insert the cartridge (above the dot on the instrument) into bar code track.
Quickly (within 1 second) slide the cartridge down past the dot.
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5. Open the cartridge door and hold the optical test cartridge so that the bar code faces
right.
6. Insert the cartridge into the compartment until a subtle snap is heard.
7. Close door.
8. Record the displayed results on the Optical Test Cartridge Results form, specific for
each analyzer, located in the DCA 2000 Analyzer Operating Manual.
9. Compared results obtained with results obtained initially.
Note: The Mean Transmittance should be within the range of 0.9500 to 1.0500, and
should not have varied by more than ±0.0100. The Standard Deviation should be less
than 0.00150 and Drift should be less than 0.01400.
10. Remove the cartridge.
As Required:
Weekly and Quarterly maintenance above may need to be done more frequently due to
spillage, contamination or troubleshooting.
Refer to each individual instruction above.
RECORDS AND RETENTION:
Record the patient results along with the Patient’s full name, MRN/DOB, date and time
of testing, the location of the testing, performing individual’s initials and evidence of
Quality Control (cartridge lot #) on the patient specific report form.
Records need to be retained for 2 years.
REPORTING AND INTERPRETING RESULTS:
1. Report results from the meter in % HbA1c.
2. Reportable range: 2.5% - 14.0%
3. Results proceeded by a less than (<) sign indicates a concentration below the lower
limit of the test. Report the result as being <2.5%.
4. Results proceeded by a greater than (>) sign indicates a concentration above the upper
limit of the test. Report the result as >14.0%.
REFERENCE RANGES:
As per therapeutic protocol.
CRITICAL VALUES;
Not applicable.
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PROCEDURAL NOTES:
1. If when scanning any cards or reagent packs you do not hear a beep sound for a
successful scan, repeat the procedure. If a beep repeatedly does not sound, try
scanning the item from below the dot on the instrument in an upward motion. If a
beep is still not heard, obtain a new reagent pack and repeat same steps as above. If
beep in still not heard, call the Teaching Assistant at 585-5247.
2. Do not use scissors to cut open foil package. Scissors can damage the reagent
cartridge, the flexible plastic pull-tab on the cartridge or the sack containing the
desiccant. Discard the reagent cartridge if any of these conditions exist.
3. Failure to allow a reagent cartridge to come to room temperature may cause
condensation to form on the optical window inside the cartridge. This will result in
erroneous results and/or an error message.
4. The reagent cartridge must be used within one hour. Do not refrigerate the cartridge
after the foil pouch has been opened.
5. Unused capillary holders may be saved and used with any lot of Hemoglobin A1c
reagent cartridge.
6. Discard the capillary holder if any of the following are missing from the holder:
Absorbent pad / glass capillary / latching mechanism
7. Once the capillary is filled with sample, analysis must begin within 5 minutes.
8. Do not allow blood to contact the plastic part of the capillary holder. Any blood
touching the plastic will be transferred into the reaction buffer, along with the blood
in the glass capillary. This can cause an invalid HbA1c result and/or an error message.
If blood does contact the plastic part of the capillary holder, discard the capillary
holder.
9. If you accidentally close the door before you pull the flexible plastic tab, you have 5
seconds to re-open the door; the display returns to “LOAD CARTRIDGE.” You may
now pull the tab or correct existing problem.
10. Record the displayed results before removing the reagent cartridge. If the door is
opened (within 15 minutes after assay completion), the test result is displayed for only
30 seconds. If the door is not opened, the test result will remain displayed for 15
minutes.
INSTRUMENT VALIDATION:
Instrument validation was performed on 10/5/01. Validation material may be obtained
from the Teaching Assistant at 585-5247.
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BACKUP METHOD:
ARUP Special Chemistry Department.
LIMITATIONS:
1. Patients with conditions resulting in hemolytic anemia may demonstrate
inappropriately decreased A1c values relative to glycemic control. Results < 2.5% are
rare and may indicate that the sample contains substantial amounts of fetal
hemoglobin, or that the patient may be suffering from hemolytic anemia or
polycythemia (conditions which often result in a significant decrease in the life span
of red blood cells).
2. If Hemoglobin F are at levels >10% of the total hemoglobin, the HbA1c level will be
lower than expected.
3. Results >14% need to be re-assayed using another method.
4. If the test result is questionable, or clinical signs and symptoms appear inconsistent
with test results, re-assay the sample or confirm the result using a different method.
5. Patients with hemoglobin values of <7.0 g/dL and >24 g/dL should have the HbA1c
measured by a different assay method
REFERENCES:
DCA 2000 Analyzer Operating Manual, copyright 1991, 1996, 2004 Bayer Corporation,
Revised 10/96, 07/04.
DCA 2000 Hemoglobin A1c Reagent Kit product insert, Revised 10/00, 05/07.
DCA 2000 Hemoglobin A1c Normal and Abnormal Control Kit product insert, Revised 4/98.
CLINICS USING PROCEDURE:
Utah Diabetes Center
PROCEDURE:
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PREPARED BY:
APPROVED BY:
DCA 2000 Analyzer
CN-CH3000
December 2008
Louis Millan
Chris Lehman
DCA 2000 ANALYZER
APPROVED BY:
DATE APPROVED:
MEDICAL DIRECTOR:
GROUP MANAGER APPROVAL:
TECHNICAL SUPERVISOR APPROVAL:
DATE ADOPTED:
RETIRED:
REPLACES: Rev.1
Copy #
Location
1
2
Master SOP Manual
Utah Diabetes Center
REVIEWED:
Date ____________ By ____________________________ Comments ________________________________________
Date ____________ By ____________________________ Comments ________________________________________
Date ____________ By ____________________________ Comments ________________________________________
Date ____________ By ____________________________ Comments ________________________________________
AUTHORIZED TO APPROVE:
Medical Director
Assistant Medical Director
AUTHORIZED TO REVIEW:
Medical Director
Assistant Medical Director
Group Manager
Technical Supervisor