Objective insight
Adds an objective tear osmolarity measurement to the dry eye evaluation.
In-Office Procedures · Diagnostic Test
ScoutPro Portable, practical, precise tear osmolarity testing.
ScoutPro is a portable, point-of-care system that quantitatively measures the osmolarity of human tears from a 50 nanoliter sample. It is a CLIA-waived test that aids in the diagnosis of dry eye disease and supports preoperative ocular surface assessment in cataract patients.
50 nLTear sample volume
SecondsTime to result
1.5%Coefficient of variation
308 mOsm/LUpper limit of normal
How it works
How ScoutPro works
A single-use test card attached to the handheld pen collects a nanoliter tear sample from the tear line and analyzes it on the spot. The osmolarity result appears on the pen display within seconds, with no docking required.
Workflow fit
Portable pen with integrated sample collection and analysis gives results in seconds at the point of care.
Preoperative assessment
Supports ocular surface evaluation before cataract surgery. Hyperosmolar patients had more refractive misses over 1.0 D (9.8% vs 0%) and greater dissatisfaction (17.1% vs 2.5%).
Epitropoulos et al. 2015; Starr et al. 2019Precision
1.5% coefficient of variation and 95% analytical accuracy compared to a standard laboratory osmometer.
Reimbursable CLIA-waived test
CLIA-waived test reimbursable under CPT 83861.
System components
ScoutPro pairs a handheld pen with single-use test cards and a compact charging base.
- 50 nL tear sample
- Results in seconds
- CLIA-waived, CPT 83861
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ScoutPro pen
Handheld reader with integrated specimen collection and analysis, LCD results and recall of up to 2 prior results.
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Test cards
Single-use, interchangeable test cards, compatible with first-generation TearLab test cards.
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Charging base
Compact, wall-mountable base charging rechargeable AAA batteries that hold a charge for 8 hours.
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Quality control
Electronic check cards for daily checks and normal and high osmolarity control solutions.
The test
Testing workflow
Evaluate, measure, discuss: identify patients where ocular surface insight is relevant, measure tear osmolarity at the point of care and use the result in planning and patient conversations.
Sample
A 50 nL tear sample is collected by lowering the test card tip until it touches the line of moisture at the eyelid, with the patient looking up and away. Test before drops, staining or slit lamp exam.
Time to result
The result appears on the pen display within seconds. Normal is below 308 mOsm/L with an inter-eye difference under 8.
CLIA-waived
Each testing site needs a CLIA Certificate of Waiver. Run the electronic check card daily and both control solutions monthly and with each new lot or shipment of test cards.
Order ScoutPro
Specifications and safety information
Technical specifications
| Sample volume | 50 nL |
|---|---|
| Time to result | Seconds |
| Result memory | Up to 2 prior results |
| Coefficient of variation | 1.5% |
| Pen power | AAA rechargeable batteries, 4.5 to 5.5 VDC, 0.6 A |
| Battery life | 8 hours per charge |
| Power input | 100 to 240 VAC, 0.6 A max, 47 to 63 Hz |
| Power output | 12 VDC, 1.5 A |
| Operating temperature | 15°C to 30°C (59°F to 86°F) |
| Operating humidity | 10% to 85% noncondensing |
| Operating altitude | 0 to 2,000 meters |
| Storage temperature | 2°C to 35°C (36°F to 95°F) |
| Equipment classification | Class III; powered by Class II power supply; Type 2 applied part; continuous service |
| In the box | Pen, charging base, AAA rechargeable batteries, power supply and cords, 2 electronic check cards, technician guide with CLIA logs |
| Sold separately | Osmolarity test cards, osmolarity control solutions, ScoutCase |
| CLIA status | Waived (CPT 83861) |
Indications for use
The ScoutPro Osmolarity System is an automated device intended to quantitatively measure the osmolarity of human tears to aid in the diagnosis of dry eye disease.
Contraindications
- 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.
Warnings and precautions
- Each laboratory or testing site using the ScoutPro must have a CLIA Certificate of Waiver before starting testing.
- Federal law restricts this device to sale by or on the order of a physician.
- DO NOT reuse test cards.
- DO NOT DOCK the pen on the charging base while waiting for results.
Common questions about ScoutPro
What is tear osmolarity?
A measure of how much salt is in the tears. High salt content, called hyperosmolarity, can damage cells on the surface of the eye.
What is a normal result?
Below 308 mOsm/L, with a difference between the two eyes of less than 8. Results above 308 mOsm/L or an inter-eye difference over 8 are abnormal.
How much tear fluid is needed?
50 nanoliters, collected directly by the test card on the pen.
How fast are results?
Results appear on the pen display within seconds, with no docking required.
Is ScoutPro CLIA-waived and billable?
Yes. It is a CLIA-waived test reimbursable under CPT 83861. Each testing site needs a CLIA Certificate of Waiver.
What quality control is required?
Test the blue electronic check card once a day before patient testing or if the pen is dropped. Test both control solution levels with each new shipment or lot of test cards and monthly.
Does ScoutPro work with TearLab test cards?
Yes. The test cards are interchangeable with first-generation TearLab test cards.
Do you sell ScoutPro outside the United States?
No. We sell and ship ScoutPro systems and test cards to practices in the USA only.
Peer-reviewed clinical studies
- Schechter B, Mah F. Ophthalmol Ther. 2022;11(3):1001-1015. PubMed
- Hirata H, et al. Invest Ophthalmol Vis Sci. 2015;56(13):8125-40. PubMed
- Huet E, et al. Am J Pathol. 2011;179(3):1278-86. PubMed
- Epitropoulos AT, et al. J Cataract Refract Surg. 2015;41(8):1672-7. PubMed
- Kursite A, Laganovska G. J Ophthalmol (Ukraine). 2023;2(511):11-15.
- Gupta PK, et al. J Cataract Refract Surg. 2018;44(9):1090-1096. PubMed
- Starr CE, et al. J Cataract Refract Surg. 2019;45(5):669-684. PubMed
- Artal P, et al. PLoS One. 2011;6(2):e16823. PubMed
- Sullivan BD, et al. Clin Ophthalmol. 2024;18:2419-2426. PubMed
Objective tear osmolarity at the point of care
A portable, CLIA-waived system that measures tear osmolarity from a 50 nL sample in seconds. Available to practices in the USA only.
ScoutPro Osmolarity System is a trademark of Trukera Medical (Bausch + Lomb). Review the full manufacturer instructions for use, including all warnings, precautions and contraindications, before use. Individual results vary.
