Raj Biosis Private Limited

INTENDED USE

The qLabs® PT-INR Test Strips are intended for in vitro diagnostic use to perform the test for patients taking oral 
anticoagulants (blood thinners) who need to monitor the clotting time of their blood.

FEATURES

• Individually wrapped

• On board quality controls

• Dry-reagent strips stored at room temperature for immediate use, no equilibration required

• High isolation between channels for high precision

• Strong correlation to central laboratory results

• Built in communication port for a printer and connectivity software

• LOW ISI as recommended by ACCP, CAP, and WHO

APPLICABLE DEVICES

qLabs^® Q-3 Plus, qLabs^® Q-3 Pro and qLabs^® Q-3

Hemostasis Analyzer Semi-automated Hemostasis Instrument Smart way to test:

• 4 independent measuring channels
• 20 incubation positions
• Easy to operate, innovative user interface
• QC management
• Master calibration curve (no calibration need)

• Bar code reading capability
• External data storage (USB device)
• Ready-to-use reagents

Increase efficiency:

• 3 reference measuring methods: clotting, immuno-turbidimetric and chromogenic
• 120 sec maximum measurement
• Maintenance free

User friendly features:

• Internal storage capacity
• Inegrated printer
• Reduced footprint
• Multiple connectivities

ECL 412 is an advanced analyzer for Complete Hemostasis. This four channel coagulation analyzer redefines the benefits in its class. Erba ECL 412, can perform PT, APTT, Fibrinogen, Thrombin Time , All Factors, Lupus , Protein S, Protein C , Antithrombin III and DDimer.

Product Features:

• Clotting Tests such as PT, aPTT, Fibrinogen, Thrombin time, Factors, Lupus anticoagulant, Protein S performed using Light scatter principle.
• Protein C, Antithrombin III done by Chromogenic Principle
• Tests like D Dimer performed using Immuno-turbidimetry principle
• Interactive touch screen interface
• Clotting Graph provides details of the clotting test
• Cuvette and reagent management software
• Twelve levels of QC with Levy-Jennings Plot- Identifies random and systematic errors
• Temperature stability at 37 degree C to perform the tests
• Low Reagent Consumption
• USB Connectivity
• CE mark

Product Applications:

• ECL 412 has uses in various routine IVD labs for doing routine PT and aPTT
• It has application in Blood Banks for Quality Control of Fibrinogen and Factor VIII
• It is used as Standby to bigger systems, in accredited centers
• It is used in Research Facilities to perform PT and aPTT on animal samples such as rat, mouse, rabbit, hamsters etc

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2. #CoagulationAssay#ClottingFactors#ThrombosisDetection#CoagulationProfile
3. #LaboratoryMedicine#CoagulationMonitoring

ECL 105 is a modern and advanced analyzer in Hemostasis. This single channel coagulation analyzer redefines the benefits in its class Erba. ECL 105 can perform PT, APTT, Fibrinogen, Thrombin Time, All Factors, Lupus and DDimer.

Product Features:

• Clotting Tests such as PT, aPTT, Fibrinogen, Thrombin time, Factors, Lupus anticoagulant performed using Light scatter principle
• Tests like D Dimer performed using Immuno-turbidimetry principle
• Interactive touch screen interface
• Clotting Graph provides details of the clotting testCuvette and reagent management software
• Twelve levels of QC with Levy-Jennings Plot- Identifies random and systematic errors
• Temperature stability at 37 degree C to perform the tests.
• Low Reagent Consumption
• USB Connectivity
• CE mark

Product Applications:

• ECL 105 has uses in various routine IVD labs for doing routine PT and aPTT
• It has application in Blood Banks for Quality Control of Fibrinogen and Factor VIII
• It is used as Standby to bigger systems, in accredited centres
• It is used in Research Facilities to perform PT and aPTT on animal samples such as rat, mouse, rabbit, hamsters etc.

ECL 760 is an advanced, fully automated random access analyzer for complete hemostasis. This seven channel coagulation analyzer redefines the benefits in its class. This system is ideal for mid-high range coagulation workload, especially for routine PT, aPTT and some rare parameters.

Product Features:

• Interactive touch screen interface/ keyboard
• Clotting Graph provides details of the clotting test
• Cuvette and reagent management software
• Twelve levels of QC with Levy-Jennings Plot- Identifies random and systematic errors and multirules.
• Temperature stability at 37 degree C to perform the tests
• Low Reagent Consumption
• Windows software
• CE mark

Product Applications:

• Clotting Tests such as PT, aPTT, Fibrinogen, Thrombin time, Factors, Lupus anticoagulant, Protein S can be performed using Light scatter principle
• Protein C, Antithrombin III can be done by Chromogenic Principle
• Tests like D Dimer can be performed using Immuno-turbidimetry principle

Hemostasis Analyzer Semi-automated Hemostasis Instrument Smart way to test:

• 4 independent measuring channels
• 20 incubation positions
• Easy to operate, innovative user interface
• QC management
• Master calibration curve (no calibration need)

• Bar code reading capability
• External data storage (USB device)
• Ready-to-use reagents

Increase efficiency:

• 3 reference measuring methods: clotting, immuno-turbidimetric and chromogenic
• 120 sec maximum measurement
• Maintenance free

User friendly features:

• Internal storage capacity
• Inegrated printer
• Reduced footprint
• Multiple connectivities

Whole Blood Point of Care System
The smallest analyzer for point of care laboratories to monitor oral anticoagulant.

Smart Way to Test:

• Dedicated safety lancet
• Single use reaction cuvette
• Innovative RFID reagent identification
• QC Management

Reduce Cost of Care:

• Disposable single-test reagent
• Whole blood analysis
• Only one drop capillary blood needed

Increase Efficiency:

• INR Screening test based on reference measurement method
• Designed for professional users
• 120 sec measurement

User Friendly Features:

• 1'000 data storage capacity
• Mobile device (internal batteries)
• Multiple connectivities

CoaguChek XS PT Test strips (in a vial):

• Box with 2 vials of 24 strips each with a code chip
• Box with 1 vial of 24 strips with a code chip FAQ

What is the recommended test frequency?

• At least twice per month, preferably once per week. This has proven to increase TTR by enabling faster reactions to variations in INR due to exercise and diet. It also increases patient compliance and engagement.

What is time in therapeutic range (TTR)?

• The percentage of time that your patients INR values fell within the upper and lower target value set by you.

Do the CoaguChek XS systems need calibration?

• No, calibration is performed automatically upon inserting the code key from the strip vial.
• What steps can I take when the readings are different to the hospital lab?
• Due to diverse measurement standards used by labs, small variations should be expected. If the variation is of therapeutic significance, please contact your local Roche support organization.

Why cant I perform a liquid quality control?

• The meter has a built in internal quality control so liquid controls are not needed.

Why are strips not single sealed as with CoaguChek S?

• Single sealing of strips is done to prevent the chemistry from moisture and light, and to maintain a shelf life as long as possible. However, it is less convenient for the customer and more expensive for the manufacturer. Each test strip vial consists of a stopper with desiccant which prevents the test strips from moisture and light.

Are there interferences when testing with CoaguChek systems?

• Polyglobulism: Hematocrit outside the standard range (25 - 55 %)
• Lupus anticoagulant: INR abnormally high
• The presence of anti-phospholipid antibodies (APAs) such as Lupus antibodies (LA) can potentially lead to prolonged clotting times, i.e. elevated INR values. A comparison to an APA-insensitive laboratory method is recommended if the presence of APAs is known or suspected.

Does the user have to run the test immediately after taking the strip out of the vial?

• The open vial stability is 10 minutes maximum. Having the strip too long out of the vial, especially in situations with high humidity or temperature, would be detected by the onboard integrity system resulting in an error message. No INR would be displayed if the strips are found to be defective by the integrated quality control of the CoaguChek XS system.

What happens if the user does not change the code key?

• If the incorrect code key is in the machine, the PT/INR value may be incorrect. Depending on the lot variation, the error can be significant causing the wrong therapeutic decision to be taken with an adverse health effect.

In what way does the CoaguChek XS PT test differ from the CoaguChek S PT test

Beside the mentioned technology the differences are:

• top and side dosing capability,
• strip storage at room temperature,
• extended % Quick measuring range,
• the low ISI value of 1.0,
• insensitivity at therapeutic levels
• and the onboard single-channel control system (OS2C) = integrity check on each strip in the same channel where blood passes, which makes it unnecessary to run liquid controls.

Micropoint Electrometer Q3:-
Diagnostics on Demand for POC Touchscreen handheld rapid testing platform Features
• Reliable laboratory results in 30 -100 seconds for PT
• 10 μL of fingertip whole blood
• On board quality control
• External liquid QC (LQC) available
• Built-in temperature controlled testing
• No calibration or instrument manipulation required

Backed by the sound production facilities, we have emerged as one of the foremost suppliers of CoaguChek XS system.

qLabs® platform, enables (Fingerstick blood) rapid testing by patient-side, so that health care professionals and patients themselves can access real-time, lab-quality results within minutes, right at Point of Care or at home. The qLabs® platform is a rapid testing system that is composed of a handheld qLabs® ElectroMeter and disposable strips. Lightweight, portable, compact and easy to use.

Features:

• Single-use and cost effective disposable strip
• Lightweight and compact handheld meter
• High precision with lab quality: 5% CV
• Fingerstick blood: less than 10 µl
• Rapid testing: 1-5 minutes
• On board quality control
• User-friendly operation
• PT results displayed in about 2 minutes
• Heparin neutralization
• Proprietary cross-talk reduction technology to ensure high precision.

Whole Blood Point of Care System
The smallest analyzer for point of care laboratories to monitor oral anticoagulant.

Smart Way to Test:

• Dedicated safety lancet
• Single use reaction cuvette
• Innovative RFID reagent identification
• QC Management

Reduce Cost of Care:

• Disposable single-test reagent
• Whole blood analysis
• Only one drop capillary blood needed

Increase Efficiency:

• INR Screening test based on reference measurement method
• Designed for professional users
• 120 sec measurement

User Friendly Features:

• 1'000 data storage capacity
• Mobile device (internal batteries)
• Multiple connectivities