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    M926S Chloride Analyser

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    Product Overview

    Providing precise measurement of Chloride in numerous sample types: the M926S Chloride Analyser is intended for general laboratory use and calibrated to give results in mmol/l Chloride. The Select Button allows the Operator to choose to work with 20µl or 100µl sample volumes. . The M926S is widely used for Chloride determination in Sweat samples

    Highlights

    • Principle coulometric method of operation is very robust, tried and tested
    • Analyser is ergonomically designed, easy to use and maintain
    • Sherwood Chloride Analyser Buffer enables outstanding performance for precision
    • Low cost per test
    • Low after test costs (reagent disposal)

    Further information about the product

    The M926S Chloride Analyser method of operation is based on a coulometric titration wherein the reagent (Silver ions) is precisely and quantitatively generated at the time of analysis by passing a constant current between electrodes. The endpoint is determined when excess Silver ions cause a change in conductivity; detected by the detector electrodes.

    Specification

    Instrument Model M926S
    Application Chloride measurement in mmol/l
    Units mmol/l
    Calibrated Sample Size 20µl and 100µl
    Readout Range 10 – 299 mmol/l
    Limit of Detection 4mmol/l for 20µl & 100ul sample
    Accuracy ± 2mmol/l at the 100 mmol/l level
    Reproducibility/Precision CV <1% for 100µl samples and CV <1.5% for 20 µl samples @100mmol/l (excluding pipetting errors)
    Measurement Time 26 seconds to 100mol/l
    Voltage (Mains Adapter Input) 100 – 240V, 50 – 60 Hz, 0.6A
    Size 315 x 200 x 250mm
    Packed Size 385 x 370 x 450mm
    Net Weight 1.9 Kg
    Gross Weight 5.4 Kg
    Packed Unit Contents M926S Chloride Analyser, Printer Cable 9 way RS232, Buffer (500ml), 100 mmol/l Chloride Standard Solution (100ml), 1 Pack of Anodes, 1 Pack of Electrodes, 2 Marked Beakers, Silver Electrode Polish, Stirrer, Operator Manual, Universal Mains Adapter and USB lead A(M) – B(M)

    Analytical Performance:

    Precision/Reproducibility:

    Using guidelines as per CLSI EP5A2, repeatability testing was performed using one M926S Chloride Analyser and one Batch of Chloride Analyser Buffer.

    Within run precision was obtained for both selectable titration volumes by performing 2 runs per day, two measurements per run for 1 standard (100mmol/l) and three concentrations of control material (Low, Medium , and High), using one M926S Chloride Analyser and Buffer from one batch (n = 80) for 20 days using both the 20µl and 100µl settings   The results were:

    For the 20µl Setting (n=80)

    Sample Mean(mmol/l) SD %CV
    0mmol/l 0.13 0.56 430.77
    3mmol/l 2.54 1.30 51.18
    23mmol/l 22.70 1.00 4.41
    50mmol/l 49.2 0.95 1.93
    98mmol/l 95.63 1.55 1.62
    100mmol/l 100.16 1.11 1.11

    For the 100µl Setting (n=80)

    Sample Mean(mmol/l) SD %CV
    0mmol/l 0.00 0.00 0
    3mmol/l 2.55 0.78 30.59
    23mmol/l 22.81 0.55 2.41
    50mmol/l 49.80 0.62 1.24
    98mmol/l 96.90 0.56 0.58
    100mmol/l 100.56 0.57 0.57


    Total precision study was performed using two M926S Chloride Analysers, buffer from two different batches and three operators.  Three levels of control materials and two Standard Solutions were analysed covering the measuring range of the device.  Controls were analysed in duplicate twice per day for consecutive 10 days (n= 240).  Summarised results are below:

    For the 20µl Setting

    Instrument 1 Instrument 2
    Sample Mean SD n Mean SD n
    100mmol/l 99.72 1.2 180 99.67 1.11 180
    0mmol/l 0.00 0.00 120 0.01 0.09 120
    3mmol/l 3.03 0.76 120 2.62 1.34 120
    10mmol/l 10.09 0.59 120 10.19 0.71 120
    23mmol/l 22.71 0.76 120 22.87 0.84 120
    50mmol/l 49.59 0.76 120 49.56 1.02 120
    98mmol/l 97.00 1.64 120 96.78 1.14 120
    Buffer Batch 1 Buffer Batch 2
    Sample Mean SD n Mean SD n
    100mmol/l 99.86 1.15 180 99.53 1.13 180
    0mmol/l 0.01 0.09 120 0.00 0.00 120
    3mmol/l 2.92 1.09 120 2.73 1.10 120
    10mmol/l 10.16 0.62 120 10.13 0.68 120
    23mmol/l 22.77 0.72 120 22.81 0.88 120
    50mmol/l 49.66 0.69 120 49.49 1.06 120
    98mmol/l 97.04 1.32 120 96.74 1.49 120

    <td”>240

    Overall
    Sample Mean SD n
    100mmol/l 99.69 1.15 360
    0mmol/l 0.00 0.00 240
    3mmol/l 2.83 1.10 240
    10mmol/l 10.14 0.65 240
    23mmol/l 22.79 0.80 240
    50mmol/l 49.58 0.90 240
    98mmol/l 96.89 1.41 240

    Total precision study was performed using two M926S Chloride Analysers, two Buffer lots and three operators. Three levels of control materials and two Standard Solutions were analysed covering the measuring range of the device.  Controls were analysed in duplicate twice per day for consecutive 10 days (n= 240).  Summarised results are below:

    For the 100µl Setting

    Instrument 1 Instrument 2
    Sample Mean SD n Mean SD n
    100mmol/l 100.65 0.74 180 100.36 0.78 180
    0mmol/l 0.00 0.00 120 0.00 0.00 120
    3mmol/l 2.75 0.69 120 2.52 0.99 120
    10mmol/l 9.94 0.42 120 9.91 0.37 120
    23mmol/l 22.94 0.37 120 22.88 0.48 120
    50mmol/l 50.19 0.47 120 50.01 0.54 120
    98mmol/l 98.23 0.76 120 97.92 0.68 120
    Buffer 1 Buffer 2
    Sample Mean SD n Mean SD n
    100mmol/l 100.60 0.76 180 100.41 0.77 180
    0mmol/l 0.00 0.00 120 0.00 0.00 120
    3mmol/l 2.66 0.76 120 2.61 0.95 120
    10mmol/l 9.95 0.36 120 9.90 0.42 120
    23mmol/l 22.89 0.44 120 22.92 0.42 120
    50mmol/l 50.10 0.35 120 50.10 0.65 120
    98mmol/l 98.21 0.73 120 97.93 0.72 120
    Sample Mean SD n
    100mmol/l 100.51 0.77 360
    0mmol/l 0.00 0.00 240
    3mmol/l 2.63 0.86 240
    10mmol/l 9.93 0.39 240
    23mmol/l 22.91 0.43 240
    50mmol/l 50.10 0.52 240
    98mmol/l 98.08 0.74 240

    Linearity/assay reportable range:

    The linearity study was based on CLSI EP6-A.  Eleven samples covering the measuring range of the Chloride Analyser system were formulated and analysed in triplicate on one instrument (Factory calibrated with a NIST traceable Chloride Standard Solution) with one reagent lot at both titration volume settings.  Results were analysed using 1st, 2nd and 3rd order least-squared regression to obtain the linear and non-linear regression coefficients.  Results were as follows:

    For the 20µl Setting

    Dilution Mean Expected values mmol/l Difference observed – Expected
    0% 0.0 -0.08 0.08
    3% 9.00 8.08 0.92
    10% 27.33 27.12 0.21
    20% 54.00 54.32 -0.32
    30% 80.67 81.53 -0.86
    40% 108.33 108.73 -0.40
    50% 136.00 135.94 0.06
    60% 164.00 163.14 0.86
    70% 191.00 190.34 0.66
    80% 217.67 217.55 0.12
    90% 244.33 244.75 -0.42
    100% 271.67 271.96 -0.29

    y = 0.9716x –0.0848, R2 = 1.0000

    For the 100µl Setting

    Dilution Mean Expected values mmol/l Difference observed – Expected
    0% 0.00 -0.33 0.33
    3% 8.00 7.99 0.01
    10% 27.33 27.40 -0.07
    20% 55.00 55.13 -0.13
    30% 82.67 82.86 -0.19
    40% 110.33 110.59 -0.26
    50% 138.33 138.32 0.01
    60% 166.33 166.06 0.28
    70% 193.67 193.79 -0.12
    80% 222.00 221.52 0.48
    90% 249.67 249.25 0.42
    100% 276.33 276.98 -0.65

    y = 0.9904x –0.3326, R2 = 1.0000

    The linearity study supports the claimed measuring range of 10 – 299 mmol/l for the M926S Chloride Analyser system and meets the recommended measuring range for Sweat Chloride Analysis by the National Cystic Fibrosis Foundation, and CLSI EPC34-A3.