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- How does the system
work?
The AtheNA Multi-Lyte® Test System is a multiplexed
system that uses the patented Luminex xMAP® technology.
Polystyrene microspheres of uniform size are used as the solid
phase. Each bead set is treated with a unique combination of two
fluorescent dyes and conjugated to a different antigen, making it
possible for the system to identify unique bead sets. These
different bead sets are mixed together in a single well to create a
multiplexed assay capable of simultaneously analyzing a single
specimen for multiple analytes. Bound analyte is detected,
qualified and quantitated by the AtheNA Multi-Lyte®
instrument using highly sensitive fluorescent dyes. See How It Works.
- How does the
internal calibration work?
Proprietary Intra-Well Calibration Technology™*, unique to the
AtheNA Multi-Lyte® Test System, automatically adjusts
the calibration curve within every well to match the unique
characteristics of the patient serum. Since calibration is
well-specific, this technology virtually eliminates issues such as
cross-plate drift, inflexible incubation schemes and complications
due to fluctuating ambient temperatures.
| Advantages of Intra-Well Calibration
Technology™* |
- Improved accuracy and precision
- No assay drift
- Automatic adjustment due to specimen condition factors
- Monitoring of specimen background
- Similarity in results reported (<100 Neg / >120 Pos /
100-120 Equivocal)
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*patent pending
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- Is calibration
single- or multi-point?
Multi-point(see above).
- Can results be
correlated to titer?
No. The ANA titer depends not only on the quantity of antibody
present, but also on the specificity of the antibodies. Most
patients with systemic lupus erythematosus (SLE) and connective
tissue disease have polyclonal antibodies, most of which are not
that specific. Because the AtheNA assay is measuring the clinically
significant antibodies, the test is going to be more accurate than
the standard FANA with far fewer false positives.
- What
steps are involved in the test procedure?
The same basic procedure is followed for all AtheNA assays. General
test steps are provided below.
| Step No.: |
Test Step: |
| 1 |
Dilute specimens according to package insert. |
| 2 |
Combine 50 μL of bead suspension and 10 μL of diluted specimen
in an empty well. |
| 3 |
Incubate at room temperature for 30 + 10 minutes. |
| 3a |
If heterogeneous assay, perform wash step. |
| 4 |
Add 150 μL of conjugate to each well. |
| 5 |
Incubate at room temperature for 30 + 10 minutes. |
| 6 |
Read results within 60 minutes. |
*See package insert for complete instructions.
- How long does the
test take to run?
The AtheNA saves time, labor and cost compared to the IFA and
ELISA. A time comparison is shown below.
|
AtheNA
- Total assay time
– 2 hours, 15 minutes
- Hands-on time
– 15 minutes
|
ELISA
- Total assay time
– 10 hours
- Hands-on time
– 1 hour, 15 minutes
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- Is the software
user-friendly?
Very, and it offers a variety of useful features:
| AtheNA Software
Features |
Bi-directional
interface
- Reports that include population statistics (positivity rates by
lot, tech, or date)
- Levy-Jennings plots (kit and in-house controls)
- Choice of reporting options (complete profile reports,
qualitative reports, user-defined analyte reports)
- Virtually unlimited data storage
- Data can be exported to spreadsheets (e.g., Excel)
The software lets users easily: 
- Set up a patient list
- Read a plate
- Time assays (built-in timer)
- Search for a specimen-by-specimen ID
- Set up new users or delete existing users
- Add a new lot
- Evaluate or query the results of previous runs
- Automatically review generated Levy-Jennings plots
- Set up and monitor the facility's own external controls
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- Can I
get a report with one patient per page?
Yes.
- How much does AtheNA testing cost?
Overall, the reagent cost per reportable should be comparable to
current methods.
- How much does the
equipment cost?
The cost of the AtheNA Multi-Lyte® instrument is
included in the reagent cost.
- How much maintenance
is involved?
Though neither difficult or time consuming, maintenance is
extremely critical to proper operation of the instrument. Inverness
Medical Professional Diagnostics offers a separate maintenance kit
with all reagents necessary for performing daily maintenance.
Maintenance must be performed, at a minimum, each morning and each
afternoon that the machine is used. The machine is preprogrammed
for AM and PM maintenance. This process is not labor intensive,
involving only a few mouse clicks on the part of the user.
In addition to daily maintenance, other types of maintenance
(e.g., calibration, cleaning) are necessary. A summary sheet of all
maintenance requirements can be printed simply by pressing a button
on the AtheNA's main screen.
- How reliable is the
equipment?
Very reliable. The AtheNA Multi-Lyte® Test System has
been in the field since 2002. The mean time to service call is
approximately six months.
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- Can I download
results to a system?
The AtheNA Multi-Lyte® software has the ability to
download via an ASTM interface or a comma-delineated file
(*.csv).
-
Can I upload patient lists into the system? What about
work lists?
Yes. These have to be handled on a case-by-case basis.
- Can I run multiple AtheNA Test System assays on the
same plate?
This feature is not available in the current generation of software
but may be made available as new software is developed.
- Will additional AtheNA applications become
available?
Yes, several infectious disease applications are currently under
development including ToRCH, HSV 1 & 2 and MMRV. And, as shown
below, many other technologies/applications have been licensed from
Luminex.
| Licensed
Technologies/Applications |
- Allergy
- Autoimmune
- Bacterial immunoassays
- Bacterial nucleic acids
- Cancer marker immunoassays
- Cancer marker nucleic acid tests
- Cardiac event immunoassays
- Coronary artery disease marker testing
- Cytokine immunoassay testing
- Ctyokine nucleic acid tests
- Drugs of abuse
- Endocrinology
- Hemostasis
- Hereditary disease testing
- HLA testing
- Identity testing
- Serum protein testing
- Mycology/parasitology immunoassays
- Mycology/parasitology nucleic acid testing
- Nutritional status testing
- Osteoporosis testing
- Therapeutic drug monitoring
- Transfusion and blood product testing
- Virology immunoassays
- Virology nucleic acid assays
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Ordering
Information
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