TearLab OSMOLARITY, Инструкция по эксплуатации

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930088 Rev M 5
TEARLAB OSMOLARITY DIAGNOSTIC PERFORMANCE
FOR DRY EYE DISEASE
Normal Dry Eye Total
≤316 32 34 66 48% NPV
>316 13 61 74 82% PPV
Total 45 95 140
Specificity 71% Sensitivity 64%
Figures 1 & 2. Distribution of Osmolarities in Normal and Dry Eye Disease subjects
Figure 1.
Osmolar
ity (mOsms/L)
Normal
Dry Eye Disease
309.9
324.3
Figure 2.
* Dry Eye distribution is not normal. It is skewed toward 400 mOsms/L.
Normal vs. Dry Eye Osmolarity
Normal
309.9 ± 11.0
Dry Eye*
324.3 ± 20.1
Pr
obabilit
y
0.05
0.04
0.03
0.02
0.01
Osmolarity (mOsms/L)
OSMOLARITY WAIVER DATA
An “untrained user” study was conducted in which participants were
given only the test instructions and asked to perform testing of 360 total
masked, randomized samples. The samples consisted of tear matrix
solution aliquoted across four levels over normal, mild, moderate and
high osmolarity. The participants were not given any training on the use
of the test. A total of 11 participants were enrolled from three sites,
representing a diverse demographic (education, age, gender, etc.)
population.
RESULTS OF UNTRAINED USER STUDY
Trained User
Average
UO
Average
Regression Analysis
(N=360 samples)
Level 1 295.3 ± 7.5 295.2 ± 6.6 y = 0.98 x + 6.51
Level 2 323.3 ± 8.4 322.9 ± 7.9 r2 = 0.9503
Level 3 339.6 ± 7.4 339.1 ± 6.7 Slope 95% CI = (0.95, 1.00)
Level 4 377.2 ± 7.2 377.0 ± 7.1 Intercept 95% CI = (-1.3, 14.3)
CONTRAINDICATIONS
Human tear fluid samples may be used. Collect tear fluid samples directly
from the eye. Refer to the TearLab Osmolarity System User Manual for
proper tear collection technique. Tear collection should be performed at
the lateral (temporal) extent of the eyelid where the risk of inadvertent
injury to the cornea can be minimized, rather than adjacent to the cornea
where injury is more likely.
• Do not collect tear fluid from a patient within two hours of medicinal eye
drop use or use of topical medications.
• Do not collect or store tear fluid samples for transport or testing at a later
time.
• Do not collect tear fluid after ocular surface staining.
• Do not collect tear fluid within 15 minutes of use of anesthetic or mydriatic
(dilating) eye drops or after other invasive ocular diagnostic testing.
• Do not collect tear fluid within 15 minutes after a slit lamp examination.
• Do not collect tear fluid within 15 minutes from a patient who has been
crying.
PATIENT TESTING PROCEDURE
(Refer to the TearLab Osmolarity System User Manual for more
information.)
1. Turn the Reader on.
2. Remove a Test Card from its package.
3. Attach a Test Card by sliding the wings of the Test Card onto the TearLab
Pen. The Pen will light up and beep when the card is attached properly.
The green light will stay on until you collect tears or the Pen times out
(after two minutes).
4. While holding the Test Card wings, remove the protective cover from
the Test Card just before tear collection.
5. Collect a tear fluid sample as described in the TearLab Osmolarity
System User Manual or Quick Reference Guide.
IMPORTANT:
Any Test Card that does not contain a protective cover should
not be used for patient testing.
6. Dock the Pen into the Reader within 40 seconds. Do NOT remove the
Test Card from the Pen before docking, or all data will be lost.
7. Locate the code on the top of the Test Card. Press the RECALL key below
the UP and DOWN arrows on the Reader keypad to match the Test Card
code. Press OK or wait eight seconds for the Reader to accept the code.
8. The Reader will display the Test Result in a few seconds. Record the Test
Result in the patient’s chart.
9. Remove the Test Card by pressing your thumb forward on top of the
Test Card. Do not pull from the wings. Dispose in an appropriate
container (refer to number eight in PRECAUTIONS).
QUALITY CONTROL
Electronic Check Card
Run the Electronic Check Card on each Pen before each day of patient
testing to confirm that the system is within the manufactured calibration
specifications. Refer to the Electronic Check Cards/Quality Control section
in the TearLab Osmolarity System User Manual for more information.
Control Solutions
Good laboratory practice suggests the use of Normal and High Osmolarity
Control Solutions to ensure that 1) Test Cards are working, and 2) the test
is being performed correctly.
Test both levels of control solution with each new shipment of Test Cards
(even if the lot number is the same), with each new lot number, and
monthly to check storage. Read the control solution instruction sheet for
expected values.
• Attach a Test Card to the Pen (refer to the TearLab Quick Reference
Guide).
• Do NOT collect tears.
• Instead of collecting tears, use a control solution.
• Use the blue sleeve to snap off the top of an ampule.
• Turn the ampule upside down (the fluid will not spill out).
• Touch the tip of the Pen to the control solution.
• Return the Pen to the Reader, and enter the code.
• Check control result to the expected value.
• If within the expected range, patient testing may proceed.