ChemoMetec NucleoCounter NC-202, Компиляция документации

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Doc.No: 994-2024 v. 1.1 · Issue date: 31-Jan-2020
Template 880-0011-79B v.3
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ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com ·
Materials
•
NC-202 PQ Kit (P/N: 912-2022)
•
15 x Via 2 -Cassette ™ (P/N: 941-0024, 100 pcs.)
Protocol
•
Select the IQ/OQ protocol in the drop-down menu, or via the protocol browser.
•
Start the analysis by selecting the Run icon or press the RUN button on the instrument.
•
Select to perform Zero Count in the message box.
•
Note in Tech note 994-2025 if Zero Count was passed.
•
Select the Count & Viability protocol in the drop-down menu, or via the protocol browser.
•
Resuspend the beads by vigorous shaking . This is to obtain a single-bead suspension, however; it is not
possible to avoid a certain degree of bead aggregation. Vortex mixing CANNOT replace shaking! (For a more
comprehensive description refer to tech note 994-2025).
•
Load a Via 2 -Cassette ™ with the bead suspension and carry out an analysis on the NucleoCounter® NC-202 ™
and note the results in the table provided in tech note 994-2025.
Important: Close the bottle and invert it gently before each of the five required measurements in order to
avoid settling of the beads. Incorrect handling of the beads may lead to higher variation of the individual
sample and the subsequent samples.
•
Calculate the average and the CV % of the obtained results to validate precision of the NucleoCounter®
NC-202
™ .
It is not recommended to use one NC-202 PQ Kit for more than one PQ test. The volume of the bead suspension in
each vial is deliberately kept greater than the volume required for five measurements, to mitigate the sample
modification effect caused by the sampling. Deviating from the this may result PQ test fail.
Even with stringent procedures for apportioning the bead slurry into the vials, variation in the total bead concentration
throughout a production lot is probable. If the total bead count average falls outside the acceptance range, while the
CV is below the specified limit, the vial probably represents such variation and ChemoMetec® customer support should
be contacted.
Statistical Analysis
To calculate whether the counting precision is in accordance with the specifications set by ChemoMetec A/S, four
statistical parameters are to be calculated namely, percent viability average, bead count average, bead count standard
deviation (SD) and bead count CV %. To calculate these values, the use of third-party spreadsheet software is
recommended, however the principles underlying these calculations are listed below.
Average % Viability
= Sum of % Viability / Numbers of counts performed
Average Bead Count = Sum of Bead Count Results / Number of counts performed
Bead Count Standard Deviation (SD):
𝑆𝐷 = √
Σ(𝑥 − 𝑦)
2
(𝑛 − 1)
Where
x
is the actual bead count,
y
is the average bead count and
n
is the number of counting assays performed.
CV % = (SD / Average bead count) × 100
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