The below chart and attachments detail the steps involved
on collecting a sample with the RTube™ (Respiratory Research,
Inc.) and the EcoScreen (Viasys Inc.). This is a time study
based on estimates and actual experience. Labor costs, depreciation
of assets, and cost of consumables are factored into the study.
The study model is that of a NIH-funded multi-center trial
currently underway in the US.
The remaining asset value of the 10 EcoScreens left over after
the study is greatly offset by the direct costs of operating
the EcoScreen. The RTube is the lower cost alternative up to
a total break-even sample collection of 7500 samples, after
which the EcoScreen is the lower cost alternative. Break-even
is the total number of collections at which the economics of
either system are equal and is calculated below. The 3000 samples
are the stated study goal and it is assumed all equipment is
fully depreciated over the study period in addition to recurring
costs of collection, hence the higher per-collection cost.
The following X samples are free of any equipment cost burden
and represent only the recurring costs of collection.
Do the algebra and the break-even point is 750 sample collections
per center. In this case, the 10-center study would perform
7500 samples before the EcoScreen would compete economically
with the RTube. Put differenly, the RTube is the lower cost
solution for any number of samples up to about 750; the EcoScreen
is the lower cost solution only if you plan to do 750 collections
or more over the service life of the equipment.
The assumes a serial usage model which does not take full
advantage of the RTube's parallel sampling capability nor the
ability to easily gather large number of samples in the field.
If these factors are weighed in, it is unlikely there is ever
a break-even point and the RTube emerges as the low-cost device
over any number of samples. The additional consistency of the
RTube cleaning process and the ability to collect, store, transport,
and plunge all in the same collection tube greatly reduces
the risk of sample contamination. The disposable patient-specific
design eliminates any cross-contamination risks.
| Step |
EcoScreen |
Time/Freq |
Notes |
RTube |
Time/Freq |
Notes |
| 1 |
Turn on (1/day) to cool (NOT INCLUDED
IN LABOR COSTING BELOW) |
30 min/ day |
Assume machine turned on/off daily |
Not required |
N/A |
Multiple cooling sleeves always immediately
available in lab/clinic freezer |
| 2 |
Clean collection tube (to reduce risk
of patient cross-contamination) |
5 min/ collection |
Inhalation through 1-way valve presents
inter-patient contamination risk |
Not required |
N/A |
Disposable device is patient-specific
and cleaned a manufacture. |
| 3 |
Clean condensation chamber insert |
4 min/ collection |
Condensation chamber must be free of
contaminants. Possible variation in cleaning technique
between centers and users with no documented standard.
Infrastructure and ~$1.00 in consumable chemicals required. |
Not required: Disposable device is cleaned
and packaged in class 10,000 cleanroom with alcohol and
reagent-grade deionized water |
N/A |
Strictly controlled cleaning procedure
is documented and executed by ISO9000 certified medical
device manufacturer. |
| 4 |
Retrieve cooling sleeve from freezer |
N/A |
Refrigeration is built into the machine
itself and requires no external cooling source. |
Multiple cooling sleeves can be stored
in the same freezer for fast swap |
1 min/ collection |
Cooling sleeve is 100% aircraft aluminum
and rapidly cools to ambient freezer conditions. |
| 5 |
Sample collection |
7 min/ collection |
Requires electrical power, nurse supervision,
and laboratory or clinic space. Only one sample can be
collected at a time |
Sample collection |
7 min/ collection |
Hand-held self-contained device can be
used anywhere by the unsupervised patient. A single research
nurse can easily monitor 50 simultaneous collections. |
| 6 |
Sample storage and transport (before
removal from condensate chamber) |
N/A |
EcoScreen has no provision for this other
than removing the sample and placing in separate storage
container. This increased handling increases exposure of
sample to contamination. |
RTube condensation cartridge doubles
as a storage tube simply by capping the ends. |
1 min/ collection |
Since sample is stored in the same chamber
it was collected in, the opportunities for handling-induced
contamination are minimized. |
| 7 |
Removal of sample |
13 min/ collection |
Sample often freezes in chamber and must
thaw. Centrifuge is needed to effectively drive droplets
inside cooling chamber to collection point. Manually swinging
the chamber in a circle can also aid collection but with
much lower efficiency and reduced condensate yield. This
also increases exposure to handling-induced contamination. |
RTube utilizes syringe-style plunging
to rapidly and easily wipe chamber walls clean even when
frozen. Simple design provides nearly complete condensate
yield in any condition. |
.5 min/ collection |
Since plunging and collection are done
in the original collection chamber, opportunities for handling
contamination are minimized. |
| 8 |
Sample Storage and transport (after removal) |
2 min/ collection
Collected droplets are poured into a separate container. |
This is a manual process where the condensate
is transferred from one container to another. |
This step can also be done with the RTube
but is not required since the sample is easily stored in
the original collection chamber. |
N/A |
|
| |
ANALYSIS
|
| |
TOTAL TIME |
31 min/ collection |
|
TOTAL TIME |
9.5 min/ collection |
Assuming one collection at a time |
| |
Labor cost/sample (one patient
at a time) |
$15.50 |
|
Labor cost/sample (one patient
at a time) |
$4.75 |
|
| |
Labor cost/sample (10 patients
at a time)
FOR REFERENCE ONLY: NOT CALCULATED INTO COSTS BELOW |
N/A |
Can not be done. The EcoScreen is a lab-based
device that is only designed to be used by one patient
at a time. |
Labor cost/sample (10 patients
at a time)
FOR REFERENCE ONLY: NOT CALCULATED INTO COSTS BELOW |
$0.38 |
The RTube allows the researcher to collect
a large number of samples simultaneously in the clinic
or in the field |
| |
Total Consumables |
$1.00/ collection |
Chemicals for cleaning |
Total Consumables |
$23.25 |
The disposable RTube assembly |
| |
Depreciation of capitol equipment assets
over life of study |
$30.67/ collection |
$9,200 purchase price per center spread
over 300 samples |
$570 purchase price per center spread
over 300 samples. (3 cooling sleeves, plunger) |
$1.90/ collection |
More cooling sleeves enable simultaneous
collection. This analysis assumes only 1 patient at a time
for comparison |
| |
TOTAL EcoScreen USAGE COSTS PER COLLECTION (with
depreciation) |
$47.17/ collection |
|
TOTAL RTUBE USAGE COSTS PER COLLECTION (with
depreciation) |
$29.90/ collection |
|