1. AEROSET & ARCHITECT cSystems MULTIGENT DOA Assay Training AEROSET PN No. 3.6.55 Version 2
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2. Presentation Contents
1- Basic Information
2- Ordering Information
3- Reaction Methodology
4- Sample Handling
5- Reagent Handling
6- Calibration
7- Quality Control
8- Precision
9- Accuracy by Recovery and Ethanol Linearity
10- Cross Reactivity and Interfering Substances
11- Method Comparison
12- Print Options
13- Assay Specific Information
14- Q & A
Attachment to Presentation Examples of AEROSET and c 8000 calibration and result printouts.
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3. Section 1 Basic Information
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4. MULTIGENT DOA Assays Launch & Customer Support
The MULTIGENT DOA assays are available for use on the AEROSET and ARCHITECT cSystems (i.e. c4000, c8000, and c16000).
Abbott will provide primary customer support, similar to all other Abbott Clinical Chemistry products.
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5. Assay Disk / CD
An ARCHITECT cSystems assay disk containing the MULTIGENT DOA Assays is planned for Q
There will be no AEROSET assay disk available. Assays can be manually configured.
Perform assay configuration per the parameters provided in the assay specific application sheets.
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6. Nine MULTIGENT DOA Assays
Qualitative & Semiquantitative DOA assays (all eight - urine only)
Amphetamine/Methamphetamine
Barbiturates
Benzodiazepines
Cannabinoids (multiple cutoffs)
Cocaine
Ecstasy (MDMA)
Methadone
Opiates (multiple cutoffs)
Quantitative DOA assay – Serum, plasma, urine
Ethanol
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7. Qualitative DOA Assays
Qualitative DOA assays provide only a preliminary screening analytical test result.
Qualitative results may be reported as the numeric value and/or as Positive / Negative.
An alternate more specific analytical method must be used to obtain a confirmed result.
Gas chromatography/mass spectrometry (GC/MS) is one well established confirmatory method.
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8. Semiquantitative DOA Assays
Semiquantitative (SQ) DOA assays still provide only a preliminary analytical test result. However, the result is reported as an approximate concentration, usually in ng/mL.
Results are “semi”-quantitative because metabolites and drugs related to the drug used for calibration may not give responses identical to the calibrator compound.
The semiquantitative result should still be confirmed since the identity of the detected drug or metabolite is often unknown.
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9. Section 2 Ordering Information
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10. Ordering Information - Reagents
*Package insert value reflects rounding “down” to 31 mL volume. Tests per kit is based on 31.7 mL fill volume.
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11. Ordering Information Multiconstituent Calibrators I (DOA MC I)
These Calibrators are used for six assays: Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cocaine, Methadone, Opiates. Each cal has a unique L/N and must be ordered separately. They do not come as a “set”.
Note: SQ applications require use of all five levels. Qualitative applications require only: DOA MC I Cal 2 and DOA MC Neg Cal.
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12. Ordering Information-Cannabinoids Calibrators
Using the available Cannabinoids calibrators, a semiquantitative (SQ) assay may be performed to an upper-limit of 100 ng/mL or 200 ng/mL. For both Qualitative and SQ applications, the MC Neg Cal is required. The Qualitative application uses the Cannabinoids 50 Cal to define the cutoff.
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13. Ordering Information - Ecstasy Calibrators
Ecstasy analysis (MDMA or methylenedioxymeth-amphetamine) requires Ecstasy calibrators. The SQ application uses all levels. The qualitative assay uses Ecstasy 500 Cal to define the cutoff. Both applications require use of the DOA MC Neg Cal.
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14. Ordering Information - Opiate Calibrators
The MC I calibrators are used for the SQ Opiates application which has an upper-limit of 6000 ng/mL. A separate set of calibrators, shown below, is used for a SQ application with an upper-limit of 1000 ng/mL. Again, the DOA MC Neg Cal is used for calibrating both SQ and qualitative applications.
Note: DOA MC I Cal 2 is used for the qualitative cutoff of 2000 ng/mL.
The Opiates 300 Cal is used for the qualitative cutoff of 300 ng/mL.
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15. Ordering Information - Ethanol Calibrators
The Ethanol assay is quantitative and has a linear calibration curve. It requires only two calibrators, as shown below.
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16. Ordering Information - Controls
There are nine (9) control products, as listed on the following two pages.
Control Name
List Number
Config.
Used for
DOA MC I Control Set
3L43-10
2x5 mL Low 2x5 mL High
Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cocaine, Opiates (when using the DOA MC I Cals), Methadone
DOA MC II Control Set
3L42-10
Ecstasy only (at this time)
Opiates Low Control Set
3L34-10
1x5 mL Low 1x5 mL High
Opiates (when using the Opiates low calibrators up to 1000 ng/mL)
Ethanol 50 Control
3L36-10
1x5 mL
Ethanol
Ethanol 300 Control
3L36-12
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17. Ordering Information - Controls (continued)
For Cannabinoids, there are four controls available for use with the SQ applications having the lower (100 ng/mL) or higher (200 ng/mL) maximum range, or for the qualitative application with a cutoff of 50 ng/mL.
Control Name
List Number
Config.
Used for
Cannabinoids 40 Control
3L41-10
1x5 mL
SQ Cannabinoids assay up to 100 ng/mL or qualitative assay with 50 ng/mL cutoff.
Cannabinoids 60 Control
3L41-12
Cannabinoids 75 Control
3L41-14
SQ Cannabinoids assay up to 200 ng/mL.
Cannabinoids 125 Control
3L41-16
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18. Section 3 Reaction Methodology
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19. Reactions: All DOAs except Ethanol
Methodology is Enzyme Immunoassay (EIA)
Specimen is added to R1 reagent.
R1 reagent contains Antibody to the drug of interest, NAD, and Glucose-6-Phosphate.
Antibody binds to drug in the specimen.
R2 reagent is added to the reaction mixture.
R2 reagent contains Enzyme (G6PD)-drug conjugate. The enzyme-labeled drug competes for antibody with drug present in the sample. Antibody not bound to drug analyte in the specimen will bind to the conjugate.
When antibody binds to the conjugate, the conjugate enzyme’s (G6PD) active site is blocked and substrate (NAD) is not converted to product (NADH) and no absorbance is produced.
(G6PD = Glucose-6-phosphate dehydrogenase)
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20. Reactions - DOAs (continued)
When there is more analyte (drug or metabolite) present in the specimen, there are more active conjugate enzymes (G6PD) available to convert substrate (NAD) to product (NADH).
This results in a greater absorbance and therefore a higher result (analyte concentration). The methodology is exactly the same for the qualitative and semiquantitative applications. The difference between the qualitative and SQ applications is in the number of calibrators used. The qualitative applications use only two calibrators; the SQ applications use five calibrators, except for cannabinoids which uses four.
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21. Reaction with R1
Antibody to the drug, NAD and Glucose-6-Phosphate in the R1 reagent is added to specimen and binds with the drug analyte contained in it.
Antibody to drug + Drug Drug: Antibody complex (Sample)
Also present in R1: NAD and Glucose-6-Phosphate
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22. Reaction with R2
Enzyme-antigen conjugate (R2) is added to reaction mixture.
Antibody not bound to drug analyte in the specimen will bind to the conjugate. This inactivates the G-6-PD.
G-6-PD-Drug Conjugate + Drug:Antibody complex
(R2)
G-6-PD-Drug:Antibody complex (Enzyme becomes inactive)
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23. Reaction: Detection of Drug
Remaining ACTIVE Enzyme-antigen conjugate catalyzes the reduction of NAD to NADH. The resultant absorbance change is measured spectrophotometrically at 340 / 412 nm.
G-6-PD-Drug Conjugate + NAD+Glucose-6-Phosphate
(Active)
NADH + 6-phosphogluconate
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24. Reaction with little or no drug
In the absence of drug in the sample, R1 antibody binds to R2 Enzyme-antigen conjugate.
This forms an INACTIVE complex of antibody and enzyme labeled drug.
NAD is not converted to NADH.
Antibody to drug + G-6-PD-Drug (Active)
(R1) (R2)
G-6-PD-Drug:Antibody complex (Inactive)
(G-6-PD = Glucose-6-phosphate dehydrogenase)
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25. Reaction – Summary
When analyte is present in the sample, enzyme activity is higher, resulting in a higher absorbance value.
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26. Section 4 Sample Handling
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27. Sample Handling – Urine DOA assays
Urine is the only acceptable specimen for Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cannabinoids, Cocaine, Methadone, Opiates, and Ecstasy.
The following materials are acceptable for urine collection containers: glass, plastic.
Frozen specimens - thaw and mix well
Turbid specimens – centrifuge as described in the package insert.
Specimen storage
5 days store frozen or refrigerated
After 5 days, store frozen at -5° C or colder
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28. Sample Handling - Cannabinoids
Certain types of plastics adsorb cannabinoids (THC) from solutions, decreasing the concentration.
To prevent adsorption:
Sample cups should be filled with 600 uL of cal, control or specimen, minimizing surface-to-volume ratio.
Do not use disposable polyethylene transfer pipettes to dispense calibrators, controls, or specimens.
Do not redispense solutions from a pipette back into a calibrator, control, or specimen container (includes redispensing after wetting a pipette tip).
Immerse pipette tips below the surface of the liquid only far enough to aspirate the needed volume.
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29. Sample Handling – Ethanol assays
Suitable specimens: serum, plasma, and urine
Clean the venipuncture site with an alcohol-free disinfectant, such as aqueous benzalkonium chloride (Zephiran).
Ensure the sample tube is kept tightly closed to prevent evaporation of alcohol.
Acceptable anticoagulants: Fluoride/oxalate, citrate, EDTA, heparin. Fluoride/oxalate preserves alcohol by preventing glycolysis.
Frozen specimens - thaw and centrifuge to remove precipitates.
Turbid specimens - centrifuge as described in the package insert.
Specimen storage
Serum and plasma:
Up to two weeks at room temperature (20 to 25°C)
Up to 6 months refrigerated (4 to 8°C)
Up to 6 months frozen (-20°C)
Urine - Up to 30 days refrigerated (4 to 8°C)
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30. Section 5 Reagent Handling
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31. Reagent Handling-All DOA assays
Supplied as liquid, ready-to-use, two reagent kit
Storage must be at 2 to 8ºC
Unopened Kit is stable to expiration date
On board stability is a minimum of 30 days
Do not freeze or expose to temperatures above 32ºC
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32. Section 6 Calibration
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33. Calibration – Qualitative DOA Assays
MULTIGENT assays use the DOA MC Neg Cal and a second cal at the cutoff concentration.
Numbers generated by the assay will either be less than or greater than the cutoff concentration. If the number is less than the cutoff, the qualitative result is “Negative”; if the number is greater than or equal to the cutoff, the qualitative result is “Positive”.
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34. Calibration – Qualitative DOA Assays
There will be five package inserts that describe the detailed use of the cals and controls, and the drug concentrations present in each product.
Seven of the eight urine assays have just a single qualitative cutoff option, and use only one cutoff calibrator in addition to the DOA MC Neg Cal.
Assay
Cutoff Concentration
Cutoff Cal Used
Amphetamine / Methamphetamine
1000 ng/mL
DOA MC I Cal 2
Barbiturates
200 ng/mL
Benzodiazepines
Cannabinoids
50 ng/mL
Cannabinoids 50 Cal
Cocaine
300 ng/mL
Methadone
Ecstasy
500 ng/mL
Ecstasy 500 Cal
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35. Calibration – Qualitative DOA Assays
One of the eight urine assays, Opiates, has two options for the cutoff concentration - a lower cutoff and a higher cutoff. Each option uses just one cutoff calibrator in addition to the DOA MC Neg Cal.
Assay
Cutoff Concentration
Cutoff Cal Used
Opiates (Low cutoff)
300 ng/mL
Opiates 300 Cal
Opiates (High cutoff)
2000 ng/mL
DOA MC I Cal 2
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36. DOA Qualitative Cutoff Summary
Cutoff calibrator concentrations used for each assay are listed below:
DRUG
CUTOFF
Amphetamine/ Methamphetamine
1000 ng/ml
Methadone
300 ng/ml
Barbiturates
200 ng/ml
Opiates 300
Benzodiazepines
Opiates 2000
2000 ng/ml
Cocaine
Cannabinoids
50 ng/ml
Ecstasy
500 ng/ml
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37. Calibration – Ethanol Assay
Calibrate with Ethanol Calibrators in duplicate.
Ethanol 0 mg/dL Calibrator, List number 3L36-01
Ethanol 100 mg/dL Calibrator, List number 3L36-02
Verify calibration by running at least two levels of controls such as 3L36-10 at 50 mg/dL and 3L36-12 at 300 mg/dL.
The Ethanol 100 mg/dL calibrator is prepared by volumetrically spiking the diluent matrix (Ethanol 0 mg/dL Calibrator) with a calculated nominal volume of reagent grade ethanol.
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38. Calibration – Semiquantitative Assays
Semiquantitative applications are calibrated using the 4 or 5 calibrators specified in the assay specific package inserts. See also Section 13, Assay Specific Information, of this presentation.
Semiquantitative applications are calibrated in a manner identical to other multi-calibrator assays such as the serum proteins.
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39. Section 7 Quality Control
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40. DOA Quality Control: Qualitative Applications
Positive and negative controls should be run at least once each day of assay use. Customers may wish to monitor the difference between control results and the cutoff concentration.
Refer to pages 16 and 17 of this presentation for information on MULTIGENT Control Products
If controls do not show the appropriate POS or NEG response, patient test results may be suspect and corrective action should be taken.
Assay recalibration may be necessary.
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41. DOA Quality Control: Semiquantitative Applications
For SQ applications, customers should define ranges which include the nominal control concentrations provided in the package inserts for the Calibrators and Controls.
Controls should be run at least once each day of assay use.
If controls values fall outside the established ranges, patient test results may be suspect and corrective action should be taken.
Assay recalibration may be necessary.
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42. Section 8 Precision
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43. Precision Claims for AEROSET and cSystems
Qualitative Applications: Precision is < 7.5% Total CV for all qualitative DOA assays.
SQ Applications: Precision is < 10% Total CV for all SQ DOA assays.
Ethanol: Precision is < 5% Total CV.
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44. Section 9 Accuracy by Recovery and Ethanol Linearity
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45. Accuracy by Recovery Semiquantitative Applications
Each SQ assay has been evaluated for accuracy by determining recovery of known analyte concentrations. Recovery values are generally between 90% and 110% with a few values falling slightly outside this range, as shown below.
Cannabinoids 10 ng/mL % (100 ng/mL cal)
Cocaine
375 ng/mL 111.8%
750 ng/mL 111.6%
Methadone
225 ng/mL 89.6%
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46. Ethanol Linearity: 10 to 600 mg/dL.
Linearity - Ethanol
Ethanol Linearity: 10 to 600 mg/dL.
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47. Section 10 Cross Reactivity and Interfering Substances
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48. Cross-Reacting Compounds
All of these DOA assays show some cross-reactivity with other drugs and compounds.
Cross-reactivity is good when it permits detection of similar drugs, but it is bad when unrelated drugs may give false positive results.
All package inserts contain tables of drugs and other compounds that cross-react in the specific assay. Tables may give the concentration that reacts equivalently to the cutoff calibrator or a concentration that still shows a negative response.
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49. Interfering Substances
A few MULTIGENT assays do provide information for interfering substances; these are Opiates, Ecstasy and Ethanol.
Abbott is acting as a distributor, and data is limited to what the vendor has available.
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50. Section 11 Method Comparison
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51. Method Comparison - Ethanol
Three method comparisons are described in the Ethanol package insert.
Slope values ranged from 1.02 to 1.10
Intercept values ranged from –1.15 and +2.05
Correlation coefficient values ranged from to 0.999
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52. Method Comparison – Urine DOA Assays
Package inserts contain method comparison data. The table below summarizes the %-agreement between AEROSET and the comparative device (A), and AEROSET vs. c 8000 (B) for the qualitative assays.
Assay A B
Amphetamine / Methamphetamine 97 99
Barbiturates
100
Benzodiazepines
Cocaine 98
Cannabinoids
Ecstasy
Methadone
Opiates-300
Opiates-2000
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53. Section 12 Print Options
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54. MULTIGENT DOA Print Options
Print options for the MULTIGENT DOA qualitative assays use two calibrators.
Print options are not included in the package insert. They are provided on the application sheets with the assay specific parameters.
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55. Print Options for AEROSET
As shown in the DOA application sheets:
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56. Print Options for cSystems
As shown in the DOA application sheets:
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57. Print Options: continued
All qualitative values should be positive numbers, and are interpreted as a negative result only if the number is below the concentration of the cutoff calibrator.
A negative result will NOT give a negative value.
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58. Section 13 Assay Specific Information
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59. MULTIGENT Amphetamine/Methamphetamine
Assay Method: enzyme immunoassay
Reagent List#: 3L37-20
Calibrator List #:
DOA MC Neg Cal: 3L43-05*
DOA MC I Cal 1: 3L43-01
DOA MC I Cal 2: 3L43-02*
DOA MC I Cal 3: 3L43-03
DOA MC I Cal 4: 3L43-04
Control List #
DOA MC I Control Set: 3L43-10
Assay Stability
On Board Stability: 56 Days
Calibration Stability: 13 Days
Assay Volumes
Specimen: uL
R1 Reagent: 100 uL
R2 Reagent: 100 uL
Smartwashes: Required on cSystems and AEROSET for ACETM, LN 2K99.
Required on AEROSET for Total Bilirubin, LN 7D60
Qualitative Cutoff Conc:
1,000 ng/mL (d-Methamphetamine)
Semiquantitative Limit
2,000 ng/mL
Limit of Detection: ng/mL
Qualitative Precision
< 7.5% Total CV
Semiquantitative Precision
< 10% Total CV
100
* Calibrators used for the qualitative application
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60. MULTIGENT Barbiturates
Assay Method: enzyme immunoassay
Reagent List#: 3L38-20
Calibrator List #:
DOA MC Neg Cal: 3L43-05*
DOA MC I Cal 1: 3L43-01
DOA MC I Cal 2: 3L43-02*
DOA MC I Cal 3: 3L43-03
DOA MC I Cal 4: 3L43-04
Control List #
DOA MC I Control Set: 3L43-10
Assay Stability
On Board Stability: 56 Days
Calibration Stability: 13 Days
Assay Volumes
Specimen: uL
R1 Reagent: 100 uL
R2 Reagent: 100 uL
Smartwashes: No smartwashes required.
Qualitative Cutoff Conc:
200 ng/mL (Secobarbital)
Semiquantitative Limit
1,000 ng/mL
Limit of Detection: 25.0 ng/mL
Qualitative Precision
< 7.5% Total CV
Semiquantitative Precision
< 10% Total CV
* Calibrators used for the qualitative application
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

61. MULTIGENT Benzodiazepines
Assay Method: enzyme immunoassay (Only assay to use Goat polyclonal Ab; all others use Mouse monoclonal Ab)
Reagent List#: 3L39-20
Calibrator List #:
DOA MC Neg Cal: 3L43-05*
DOA MC I Cal 1: 3L43-01
DOA MC I Cal 2: 3L43-02*
DOA MC I Cal 3: 3L43-03
DOA MC I Cal 4: 3L43-04
Control List #
DOA MC I Control Set: 3L43-10
Assay Stability
On Board Stability: 56 Days
Calibration Stability: 7 Days
Assay Volumes
Specimen: uL
R1 Reagent: 100 uL
R2 Reagent: 100 uL
Smartwashes: Required for AST LN 7D81, ALT LN 7D56, Lipase LN 7D80, T.Bil LN 8G62, Acet LN 2K99.
Qualitative Cutoff Conc:
200 ng/mL (Oxazepam)
Semiquantitative Limit
1,000 ng/mL
Limit of Detection: 18.6 ng/mL
Qualitative Precision
< 7.5% Total CV
Semiquantitative Precision
< 10% Total CV
* Calibrators used for the qualitative application
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

62. MULTIGENT Cannabinoids-100
Assay Volumes
Specimen: uL
R1 Reagent: 100 uL
R2 Reagent: 100 uL
Smartwashes: No smartwashes required for cSystems.
Required on AEROSET for Lithium, LN 8L25.
Qualitative Cutoff Conc:
50 ng/mL (11-nor-delta-9-THC)
Semiquantitative Limit
100 ng/mL
Limit of Detection: 10.0 ng/mL
Qualitative Precision
< 7.5% Total CV
Semiquantitative Precision
< 10% Total CV
Assay Method: enzyme immunoassay
Reagent List#: 3L41-20
Calibrator List #:
DOA MC Neg Cal: 3L43-05*
Cannabinoids 20 Cal: 3L41-01
Cannabinoids 50 Cal : 3L41-02*
Cannabinoids 100 Cal : 3L41-03
Control List #
Cannabinoids 40 Control: 3L41-10
Cannabinoids 60 Control: 3L41-12
Assay Stability
On Board Stability: 30 Days
Calibration Stability: 13 Days
* Calibrators used for the qualitative application
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

63. MULTIGENT Cannabinoids-200
Assay Method: enzyme immunoassay
Reagent List#: 3L41-20
Calibrator List #:
DOA MC Neg Cal: 3L43-05
Cannabinoids 50 Cal : 3L41-02
Cannabinoids 100 Cal : 3L41-03
Cannabinoids 200 Cal : 3L41-04
Control List #
Cannabinoids 75 Control: 3L41-14
Cannabinoids 125 Control: 3L41-16
Assay Stability
On Board Stability: 30 Days
Calibration Stability: 13 Days
Assay Volumes
Specimen: uL
R1 Reagent: 100 uL
R2 Reagent: 100 uL
Smartwashes: No smartwashes required for cSystems.
Required on AEROSET for Lithium, LN 8L25.
Qualitative Cutoff Conc:
Not applicable – No qualitative app.
Semiquantitative Limit
200 ng/mL
Limit of Detection: 10.0 ng/mL
Qualitative Precision
< 7.5% Total CV
Semiquantitative Precision
< 10% Total CV
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

64. MULTIGENT Cocaine Assay Method: enzyme immunoassay
Reagent List#: 3L40-20
Calibrator List #:
DOA MC Neg Cal: 3L43-05*
DOA MC I Cal 1: 3L43-01
DOA MC I Cal 2: 3L43-02*
DOA MC I Cal 3: 3L43-03
DOA MC I Cal 4: 3L43-04
Control List #
DOA MC I Control Set: 3L43-10
Assay Stability
On Board Stability: 56 Days
Calibration Stability: 13 Days
Assay Volumes
Specimen: uL
R1 Reagent: 100 uL
R2 Reagent: 100 uL
Smartwashes: Required on AEROSET and cSystems for Amikacin LN 6L35, Digoxin LN 1E06, Digitoxin LN 6K40, Tobramycin 7F93, and Vancomycin LN 6E44.
Required on cSystems for Gentamicin 1E11.
Ceruloplasmin, LN 6K91, requires smartwash for Cocaine on AEROSET and c 8000.
Qualitative Cutoff Conc:
300 ng/mL (Benzoylecgonine)
Semiquantitative Limit
1,000 ng/mL
Limit of Detection: 40.0 ng/mL
Qualitative Precision
< 7.5% Total CV
Semiquantitative Precision
< 10% Total CV
* Calibrators used for the qualitative application
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

65. MULTIGENT Methadone Assay Volumes Assay Method: enzyme immunoassay
Specimen: uL
R1 Reagent: 100 uL
R2 Reagent: 100 uL
Smartwashes: No smartwashes required.
Qualitative Cutoff Conc:
300 ng/mL (Methadone)
Semiquantitative Limit
1,000 ng/mL
Limit of Detection: 10.0 ng/mL
Qualitative Precision
< 7.5% Total CV
Semiquantitative Precision
< 10% Total CV
Assay Method: enzyme immunoassay
Reagent List#: 3L35-20
Calibrator List #:
DOA MC Neg Cal: 3L43-05*
DOA MC I Cal 1: 3L43-01
DOA MC I Cal 2: 3L43-02*
DOA MC I Cal 3: 3L43-03
DOA MC I Cal 4: 3L43-04
Control List #
DOA MC I Control Set: 3L43-10
Assay Stability
On Board Stability: 56 Days
Calibration Stability: 10 Days
* Calibrators used for the qualitative application
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

66. MULTIGENT Opiates-2000 Assay Volumes Assay Method: enzyme immunoassay
Specimen: uL
R1 Reagent: 100 uL
R2 Reagent: 100 uL
Smartwashes: No smartwashes required.
Qualitative Cutoff Conc:
2,000 ng/mL (Morphine)
Semiquantitative Limit
6,000 ng/mL
Limit of Detection: 44.1 ng/mL
Qualitative Precision
< 7.5% Total CV
Semiquantitative Precision
< 10% Total CV
Assay Method: enzyme immunoassay
Reagent List#: 3L34-20
Calibrator List #:
DOA MC Neg Cal: 3L43-05*
DOA MC I Cal 1: 3L43-01
DOA MC I Cal 2: 3L43-02*
DOA MC I Cal 3: 3L43-03
DOA MC I Cal 4: 3L43-04
Control List #
DOA MC I Control Set: 3L43-10
Assay Stability
On Board Stability: 56 Days
Calibration Stability: 13 Days
* Calibrators used for the qualitative application
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

67. MULTIGENT Opiates-300 Assay Method: enzyme immunoassay
Reagent List#: 3L34-20
Calibrator List #:
DOA MC Neg Cal: 3L43-05*
Opiates 150 Cal: 3L34-01
Opiates 300 Cal: 3L34-02*
Opiates 500 Cal: 3L34-03
Opiates 1000 Cal: 3L34-04
Control List #
Opiates Low Control Set: 3L34-10
Assay Stability
On Board Stability: 56 Days
Calibration Stability: 13 Days
Assay Volumes
Specimen: uL
R1 Reagent: 100 uL
R2 Reagent: 100 uL
Smartwashes: No smartwashes required.
Qualitative Cutoff Conc:
300 ng/mL (Morphine)
Semiquantitative Limit
1,000 ng/mL
Limit of Detection: 10.3 ng/mL
Qualitative Precision
< 7.5% Total CV
Semiquantitative Precision
< 10% Total CV
* Calibrators used for the qualitative application
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

68. MULTIGENT Ecstasy Assay Method: enzyme immunoassay
Reagent List#: 3L42-20
Calibrator List #:
DOA MC Neg Cal: 3L43-05*
Ecstasy 250 Cal: 3L42-01
Ecstasy 500 Cal: 3L42-02*
Ecstasy 750 Cal: 3L42-03
Ecstasy 1000 Cal: 3L42-04
Control List #
DOA MC II Control Set: 3L42-10
Assay Stability
On Board Stability: 56 Days
Calibration Stability: 13 Days
Assay Volumes
Specimen: uL
R1 Reagent: 100 uL
R2 Reagent: 100 uL
Smartwashes: No smartwashes required.
Qualitative Cutoff Conc:
500 ng/mL (MDMA)
Semiquantitative Limit
1,000 ng/mL
Limit of Detection: 22.0 ng/mL
Qualitative Precision
< 7.5% Total CV
Semiquantitative Precision
< 10% Total CV
* Calibrators used for the qualitative application
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

69. MULTIGENT Ethanol Assay Method: Alcohol dehydrogenase
Reagent List#: 3L36-20
Calibrator List #:
Ethanol Neg Cal: 3L36-01
Ethanol 100 Cal: 3L36-02
Control List #
Ethanol 50 Control: 3L36-10
Ethanol 300 Control: 3L36-12
Assay Stability
On Board Stability: 56 Days
Calibration Stability: 13 Days
Assay Volumes
Specimen: uL
R1 Reagent: uL
R2 Reagent: uL
Smartwashes: No smartwashes required.
Cutoff Conc:
Not applicable - Quantitative Assay
Limit of Detection: 0.4 mg/dL
Reportable Range:
10 to 600 mg/dL
Suitable Specimens: serum, plasma, urine
Anticoagulants Tested:
EDTA Citrate Fluoride/Oxalate Heparin
Precision
< 5 % Total CV
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

70. Section 14 Q & A
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

71. Questions and Answers
Why are Ethanol results higher on the c 8000 System than the AEROSET System? (Y=1.10x-1.15).
Data presented in the package insert indicate that
c 8000 may give higher Ethanol values. However we must remember that any such study is a “snapshot” of specific instruments and reagents. European (German) quality requirements permit a total error for Ethanol of 20% at or above 100 mg/dL and 20 mg/dL below 100 mg/dL. Values from both systems are within this range.
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

72. Questions and Answers How should qualitative controls be monitored?
Some users may wish to monitor the difference between the control result and the cutoff calibration concentration. If the cutoff concentration is 300 ng/mL, and the negative control consistently gives values around 275, then this difference of 25 can provide a check of assay consistency. However, this difference will be affected by reagent lot, calibrator lot and control lot. There is no defined specification for this difference.
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

73. Questions and Answers
Cannabinoids and Cocaine have calibrator levels that exceed 110% in the accuracy by recovery study? Are these levels considered out of specification? How can the data be explained?
There was no numeric requirement for this recovery testing. This is because these DOA assays are SEMI-quantitative. The calibration curve-fit is not as optimized as for a fully quantitative assay. Therefore, recovery values may vary in different regions of the cal curve. The assays still provide an approximate indication of drug concentration, which is what they are designed to do.
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

74. Attachment to Presentation Examples of AEROSET and c 8000 calibration and result printouts.
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

75. Example of AEROSET Calibration Printout
SQ Benzodiazepines: Five cal points
A Qualitative Cal Curve will look much the same – except, only two cals, ‘0’ and 200 and the line will be straight, not curved.
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

76. Example of AEROSET Result Printout
Qualitative Benzodiazepines: Cutoff 200 ng/mL
No flag if result is LESS THAN
the assay cutoff.
‘H’ Flag if result is EQUAL TO or GREATER THAN the assay cutoff.
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

77. Example of c 8000 Calibration Printout
SQ Benzodiazepines: Five cal points
A Qualitative Cal Curve will look much the same – except, only two cals, ‘0’ and 200 and the line will be straight, not curved.
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

78. Example of c 8000 “Sample Report” Printout
Qualitative Benzodiazepines: Cutoff 200 ng/mL
Printout will show a numeric value (not a concentration!) and an interpretation: Positive or Negative
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

79. Example of c 8000 “Details Report” Printout
Qualitative Benzodiazepines: Cutoff 200 ng/mL
Printout will show a numeric value (not a concentration!) and an interpretation: Positive or Negative
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,

80. Example of c 8000 “List Report” Printout
Qualitative Benzodiazepines: Cutoff 200 ng/mL
Printout will show a numeric value (not a concentration!) and an interpretation: Positive or Negative
End of Document
Formal approval and revision history of this document can be found in the AEROSET Project Notebook, Version 2
For Information Use Only, unless accompanied by associated electronic approval sheet from AEROSET Project Notebook,