Labmaster LUCIA™ Analyzer and Labmaster LUCIA™ test kits
Point-of-care (POC) testing (also known as near-patient testing, NPT) is medical diagnostic testing performed near the patient, e.g. at the doctor’s office or a patient care facility. Point-of-care test results are ready in a matter of minutes. These results provide rapid information for aid in diagnostic decision-making and patient’s care plans. Similarly, veterinary POC tests are performed at animal clinics, or in non-clinical settings such as stables and other animal care facilities.
POC reduces the need for laboratory testing, expedites diagnostic decision-making and monitoring of treatment.
POC tests can be performed by laboratory professionals at laboratory service points, but usually they are performed by healthcare professionals (nurses, paramedics and doctors not trained in laboratory work) outside of a laboratory setting; near the patient and at the site where care or treatment is provided.
Veterinary point-of-care tests can be performed by anyone familiar with the POC equipment, e.g. at animal care clinics, stables and other care facilities.
The Labmaster LUCIA™ is a point-of-care immunoassay platform based on patented cathodic electrochemiluminescence (LM-CECL) technology. It enables fast, accurate and affordable human and veterinary diagnostics. The Labmaster LUCIA™ Analyzer performs the measurement on whole blood, serum or plasma samples and returns the quantitative or qualitative result in a matter of minutes.
The Labmaster LUCIA™ product family includes the compact and easy-to-use analyzer and several innovative point-of-care test kits. The test kits are intended for measuring designated analytes using the Labmaster LUCIA™ Analyzer, including CRP, MxA, SARS-CoV-2 IgG NP, SARS-CoV-2 IgG RBD, and in veterinary diagnostics equine SAA, Foal IgG, Canine CRP and Feline SAA.
The Labmaster LUCIA™ Analyzer is to be stored in dry and clean conditions where it is not placed in direct sunlight. The storage temperature range is from +18 °C to +30 °C.
The storage conditions are the same for the Labmaster LUCIA™ Vet Analyzer.
The Labmaster LUCIA™ test kit contains test specific cassettes, dilution tubes or other reagents for preparing the sample, an assay and lot specific NFC card and instructions for use.
With IVD diagnostics, the CRP and MxA test kits include components for transferring the sample. However, it is also possible to use a pipette for sample transfer.
With veterinary diagnostic test kits, the 10 µL Single Volume Pipette and the 10 µL Filter Tip rack are available separately.
Materials for sample collection (e.g. lancets, needles, blood collection tubes) are not included in the Labmaster LUCIA™ test kit. They must be acquired separately.
The storage temperature for Labmaster LUCIA™ test kit is +2 °C to +8 °C. The kit can for example be stored in the refrigerator.
It is recommended that only the required number of tests and components are taken out to room temperature when performing a measurement.
Refer to the Labmaster LUCIA™ test kit insert to check the storage temperature and related information.
Labmaster LUCIA™ tests can be performed using a fingertip or venous whole blood sample. Some of the in vitro diagnostic tests can be performed using a serum or plasma sample.
Veterinary tests are performed using a venous whole blood sample or serum or plasma sample.
Refer to the kit insert of the test in question to make sure you are using the appropriate sample type.
To receive a reliable result the sample must be added immediately into the dilution tube unless the test kit insert instructs otherwise.
Refer to the test kit insert in question for the detailed instructions on how long the sample can be stored after being added into the dilution tube. The storage time depends on the test in question.
After the storage time has been exceeded, the Labmaster LUCIA™ test result is no longer reliable.
The Labmaster LUCIA™ CRP and MxA (IVD) test kits contain the required sample transfer equipment for performing the test. However, it is also possible to use a pipette for sample transfer.
With veterinary test kits, the 10 µL Single Volume Pipette (available separately) or any applicable 10 µL pipette (not provided in the test kit) can be used for sample transfer.
These components might vary between different tests, which is why it is of utmost importance to use only the test-specific components when performing the test.
With most Labmaster LUCIA™ tests it is possible to use pipette for sample transfer in place of the components included in the kit.
Refer to the test kit insert in question whether using pipette is possible.
Only the NFC card included in the test kit in question is to be used when performing the test. The NFC card is test and batch-specific, which means that it is encoded to return the correct result for the test kit batch in question. If another NFC card is used, it will produce a false result.
Ensure that a correct NFC card is being used by comparing the batch information on the NFC card label to the batch information on the test kit in question.
The measuring time varies between different Labmaster LUCIA™ tests. The shortest measuring time is 6 minutes, and the longest is 11 minutes.
Refer to the Labmaster LUCIA™ test kit insert in question that all instructions were followed and that the test kit has been stored according to instructions.
Ensure that the Labmaster LUCIA™ test kit has not expired.
Ensure that the kit-specific NFC card was used and that the NFC Card lot information correspond to that of the Labmaster LUCIA™ test kit.
Refer to the Labmaster LUCIA™ Analyzer Instructions for Use and the test kit insert for Trouble-shooting solutions.
For further assistance, contact the Labmaster technical support: email@example.com.
Expired Labmaster LUCIA™ test kits should not be used.
The Labmaster LUCIA™ Analyzer and the Labmaster LUCIA™ test kits are factory calibrated. The use of third-party control materials is advised to assure the day-to-day validity of results.
Refer to the Labmaster LUCIA™ test kit insert in question for specific instructions on quality control.
Sample collection materials (lancets, needles, blood collection tubes) are not included in the Labmaster LUCIA™ test kit. They must be acquired separately. The IVD test kits (Labmaster LUCIA™ CRP and MxA) contain all materials for performing the test.
With veterinary test kits, the 10 µL Single Volume Pipette is available separately and is not provided in the test kit.
With most Labmaster LUCIA™ tests it is possible to use pipette for sample transfer in place of the components included in the kit. Refer to the test kit insert in question whether using pipette is possible.
Performing the tests does not require calibration. The Labmaster LUCIA™ Analyzer and the test kits are delivered factory calibrated.
Measurement results can be exported from the Labmaster LUCIA™ Analyzer to a Windows PC or an Android device. For more information on result export, please refer to the Labmaster LUCIA™ Analyzer Instructions for Use.
The results cannot be exported straight from the analyzer into the electronic health record system.
Refer to the Labmaster LUCIA™ Instructions for Use for troubleshooting solutions.
For further assistance, please contact the Labmaster technical support: firstname.lastname@example.org.
Labmaster Ltd offers a two-year warranty for new analyzers. For more information on the warranty, refer to the Labmaster LUCIA™ Analyzer Instructions for Use.
The Labmaster LUCIA™ Analyzer or the Labmaster LUCIA™ Vet analyzer do not require maintenance or calibration. The device is delivered factory calibrated.
For further information on Analyzer cleaning, please refer to the analyzer Instructions for Use.
Tel. +358 22 760 555
Rauhalinnantie 31, 20780 KAARINA, Finland
Products designed, developed and manufactured by Labmaster Ltd. meet their specifications when stored, used and transported according to the instructions for use and product inserts. Labmaster LUCIA™ is a trademark designed and owned by Labmaster Ltd.
Not all products are available in all regions. Check with your local representative for availability in specific markets.