LabPad® INR

The smart device for PT/INR test

LabPad® adapted for PT/INR test in the lab

The LabPad® INR is an In-Vitro Diagnostic (IVD) device designed to measure blood coagulation time and indicate INR value (International Normalized Ratio), Prothrombin Time (PT), and the Quick Time (QT). Use of the LabPad® INR has been adapted for monitoring of your oral anticoagulant treatment through type vitamin K antagonists (VKA).

Description of the LabPad® device for PT/INR test
LabPad® displays three results for PT/INR test

The LabPad® INR system

To perform a PT/INR test with Avalun testing device, you will need:

  • The LabPad® INR with its battery charger
  • Tsmart® INR microcuvettes individually packed in boxes of 12, 24, or 48 units
  • A carrying bag for all you need to perform a test

Complementary elements that are not provided with the device and that are necessary to perform a test properly are the following:

  • A 21G lancet or a lancing device adequate for healthcare professional use
  • Dressing gauze or a paper tissue
  • A bandage
Elements required for the PT/INR test system

3 steps for an efficient handling of blood sample

Step 1: inserting the microcuvette

Place your LabPad® INR on a stable, flat, and vibration-free surface and use single-use gloves. Insert the Tsmart® INR microcuvette in the insertion area. The device switches on.

PT/INR test for healthcare professionals of the laboratory
Microcuvette for PT/INR test performed in laboratory

Step 2: sampling and applying blood

Disinfect the finger of the patient and leave it to dry completely or dry it with a soft rag or lint-free cloth. The patient’s hand must be warm and relaxed. Prick on the side of the fingertip, preferably the ring or middle finger.

Apply light pressure to the finger and massage it towards the fingertip to get a drop blood with a sufficient volume (3µL minimum).

Capillary blood needed for PT/INR test
Drop of blood required for PT/INR test with LabPad®

“How to apply the blood drop onto the microcuvette Tsmart® INR

Step 3: Discarding the microcuvette and result reviewing

To discard the Tsmart® INR microcuvette, pick up your LabPad® INR, turn it down face towards the floor above a bin or any other appropriate recipient, and press the side blue button.

How to discard the PT/INR test microcuvetteOnce the Tsmart® INR is discarded, the screen displays the list of results with the newest result at the top.

LabPad® INR user guide

Tsmart® INR instructions for use

What is the Tsmart® INR microcuvette ?

The Tsmart® INR microcuvette is an In-Vitro Diagnostic (IVD) medical device used for measuring the clotting activity of the blood with the LabPad® INR. It can be used with whole capillary blood or non-anticoagulated venous blood.

Microcuvette to perform PT/INR test

Microcuvette individually packed for PT/INR test

Applying blood

When the “drop blood” icon is displayed, prick the side of the fingertip and drop the blood on the Tsmart® INR microcuvette curved plate without squeezing the finger.

When the Tsmart® INR is properly filled, you hear a “beep”. Remove the finger of the patient.

How to perform a PT/INR test

Automatic release

Do not try to pull out the Tsmart® INR, as you may damage the microcuvette and leave part of it inside the device.

Precautions of use during PT/INR test

Specifications

Operating conditions

Operating conditions

LabPad® INR

Flat, stable and vibration-free surface

Place properly enlightened

Ambient temperature 15-32°C

Relative humidity level < 85%

Tsmart® INR microcuvette

The desiccant must be orange

In ambient temperature before use

Within 10 min after opening the pouch

Storage conditions

LabPad® INR

-10°C to +50°C (14°F to 131°F)

Tsmart® INR microcuvette

Between 2 and 32°C until the expiry date indicated on the pouch

Possible refrigeration

Transport conditions

LabPad® INR

-20°C to +70°C

Tsmart® INR microcuvette

-20°C to +50°C

In its cover

Power off

After 2 minutes by default

Can be set from the “Settings” menu

INR measuring

Measuring range

INR 0.8-8

PT 7.2 -72 seconds

QT 10-110%

Analysis time

~ 1 minute

ISI

~1
Quality controls

LabPad® INR and Tsmart® INR microcuvette

Quality controls every time a Tsmart® INR microcuvette is inserted:

– electronic components

– reagent lyophilized and embedded inside the microcuvette

– filling of the micro channel

Features

Size

L 17.25 cm

W 7.21 cm

H 3.18 à 2.26 cm

Weight

230g net

User interface

Interface with two browse buttons and one central validation button

Color display

Easy settings

USB interface

Micro USB B port

Beep

4000 Hz

Memory

1,000 measurements with the date and time

Battery charger

Supplied with the device

Power pack 100-240v, 50-60Hz, input 0.2A, output 1.0A

Battery autonomy

Between 40 and 70 tests when the battery is completely recharged

3 months without use

Bluetooth

Low Energy

Can be set from the “Settings” menu

Biological waste management

Preferably in a bin specially dedicated to infectious clinical waste
Blood sample

Type of blood sample

Capillary blood or non-anticoagulated venous blood

Blood sample size

3µL minimum (1 drop)

Test limitations and interferences

  • Bilirubin                              up to 513 µmol/L (30mg/dL)
  • Hematocrit range           between 25 and 55%
  • Hemolysis                          up to 1 000mg/dL (Hemoglobin)
  • Triglycerides                     up to 11.3 mmol/L (1 000mg/dL)

Use of an alternative method of measurement is recommended in the event of a transition period with a heparinized treatment.

The clotting factor sensitivity for Factors II, V, VII and X has been evaluated. Data are available for healthcare professionals only, upon request.

If the presence of anti-phospholipid antibodies (APAs) is known or suspected, refrain from using. Such presence may cause incorrect results.

Do not use with New Oral Anti Coagulants (NOACs).

Tsmart® INR instructions for use

FAQ

Quality controls of the device

How are the quality controls performed?

No external controls are required; all controls are performed internally. Every time a Tsmart® INR microcuvette is inserted , the electronic components, the lyophilized reagent embedded inside the microcuvette, and the micro channel filling are controlled.
Performances of the device

How has the LabPad® INR Accuracy been assessed?

The LabPad® INR performances and its reliability have been assessed with two clinical trials, in 2014 and 2016.
Performing a test with the device

How can I be assured that the device will not switch-off during measurement?

The LabPad® INR cannot switch-off during a measurement. If the battery charge becomes too low, or if the device memory is full or else if the battery is empty, the LabPad® INR displays an icon or an error message at the beginning of the measurement. You cannot perform the measurement then.

Why should I use the microcuvette at the latest within 10 minutes after opening the pouch?

The microcuvette contains a lyophilized reagent sensitive to ambient humidity. Once the microcuvette is out of its pouch, the lyophilized reagent absorbs humidity and loses its properties in several minutes. The microcuvette is then unusable.

Is it important to wait for the “Drop blood” icon to appear on the screen before applying the blood drop onto the microcuvette?

Yes. You have 2 minutes to apply the blood drop onto the microcuvette. This period of time is more than enough to prick the patient finger, obtain a blood drop of a sufficient volume and apply the blood drop without hurry. When this icon is displayed, it means that the temperature of the microcuvette is correct (37°C) and that your device is ready to perform a test. Beyond these 2 minutes, if you have not applied the blood, the device will generate an error. You will then have to repeat the test.

Where can I find the expiry date of the microcuvette?

The expiry date is on the individual pouch in which the microcuvette is packed, as well as on the boxes of 12, 24, or 48 units. The LabPad® INR reads the expiry date coded in the Datamatrix when a microcuvette is inserted.

Can I press the patient finger on the microcuvette plate to ease the filling?

No, you may block the micro channel. Applying the blood drop must be completed in one go. You must apply blood gently and carefully, by approaching the finger towards the plate. The central micro channel is designed to suck the blood in as soon as the drop touches the center of the plate.

Why should I apply the blood in one go?

If you do not apply the blood drop in one go, the device may not detect properly the blood coagulation. An error message will then be displayed on the screen. You will then have to repeat the test with a new microcuvette.

Is it possible to repeat the test in case of an abnormal result?

Yes. Discard the used microcuvette and use a new microcuvette. Prick another finger and repeat the test.
Characteristics of the Tsmart® INR microcuvette

Can the LabPad® INR perform other biological tests?

The LabPad® INR works with Tsmart® INR and enables the measurement of the coagulation time (PT/INR). The optical technology of the LabPad® will eanble in the future the measurement of other biological tests.