LACTATE DETECTION SYSTEM

          

The LactoMeter analyzer is a handheld device that pack all the features required by athletes and coaches to accurately assess the capability of the muscles for an athletic performance.

Lactate measurement in blood is far more precise than the old and inefficient method of using percentage of maximum hearth rate to set training zones.

There are many factors influencing the Rate of Lactate Accumulation in the body such as:

 

·         Absolute Exercise Intensity

·         Training Status of Active Muscles

·         Fibre Type Composition  

·         Distribution of Workload 

·         Rate of Blood Lactate Clearance

 

It is fundamental for athletic training to determine the Individual Lactate Threshold by repeating lactate tests during specific exercises in order to prevent OBLA: the onset of blood lactate accumulation with consequent reduction of performance up to muscle contraction inhibition.

 

The LactoMeter holds up to 300 results, each date and time stamped, any users can transfer these results into a PC for in dept analysis. It can be used by coaches, trainers, sports scientists, sport medicine personnel in training of individuals and teams at all levels of competition, or as a flexible and inexpensive tool complementary to Lab analysis.

 

Main features

  • Advance biosensors test strips

  • Low blood volume required: only 3 microliters blood.

  • Measuring range: 6 to 200 mg/dL

  • Fast testing time: 45 sec.

  • Date and time stamped memory

  • Large LCD display

  • Small size

  • PC interface

 

Specification

 

 Measuring range

 6 – 200 mg/ dL

Sample volume  

 3 microl whole blood

Measuring time   

 45 sec

Precision 

 mCV < 5%

HCT % range

35% - 50%

Operating environment

10 °C – 40°C; Humidity 20 % - 80% (RH)

Battery life

Approx 1000 tests

Calibration

External code card

Memory Capacity

300 sets with date & time

Temperature compensation

Auto sensing compensation

Battery source

1 x CR2032 3.0V lithium battery

PC Interface

RS 232

Audible Beep

Yes

Weight

64 g with battery

 

PRECISION EVALUATION STUDY

Derived by the Technical file for CE marking

The  LactoMeter precision assay includes within-run and between-run assay.

The Within-run tests were performed by using venous heparinised whole blood.

The whole blood was spiked to provide samples at four different lactate concentrations.

Between-run tests were performed by using two levels of lactate control solutions.

The reference method used was the L-lactate (PAP) kit by Randox, that is the enzymatic determination of L-lactate.

The Within-run precision assay contains ten replicates of each of the four spiked whole blood lactate levels.

The Between-run precision tests   consisted  of six replicates per day at the two lactate concentrations, for six days.

Each sample was tested on the lactate meter with same lot of test strips.

Finally, all lactate concentrations were determined by the L-Lactate (PAP) kit.

The mean (mg/dL), standard deviation (SD, mg/dL) and coefficient of variation (CV, %) were calculated for each test set.

 

Acceptance criteria.

Mean CV% of within run and between-run components of precision shall be  <5%.

Results: Exhibit 1 and Exhibit 2 contain the results of the Within-run and Between-run tests.

Precision: the mean coefficient of variation is 2.5% and 2.6% respectively.