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2021-01
6.
Quality control according to the Guideline of the
German Medical Association
1)
The Gyn Photometer has been specially developed for near-patient immediate
diagnostics with unit-use reagents (German Medical Association, part B, chapter
2.1.5). According to the guideline of the German Medical Association, there is
therefore no obligation to participate in surveys (German Medical Association, part
B, chapter 2.2, paragraph (3) a). The user only has to carry out internal quality
checks.
Internal quality assurance is carried out in the form of a weekly accuracy check
(calibration) with subsequent documentation of the measured value. The
corresponding protocol forms are available from Diaglobal free of charge.
We recommend using the Diaglobal control solution GLU QS to check the accuracy
of glucose determinations
.
We recommend using the blood control HEM QS and ERY QS with target values in
the normal concentration area for checking the accuracy of determinations of
haemoglobin, haematocrit and erythrocyte counts.
In agreement with the requirements of the German Medical Association, a test of
the device function (see operating instructions, chapter 8.5) is integrated in the
Gyn Photometer, therefor a daily test by means of a standard manual test
(German Medical Association, part B, chapter 2.1.5, paragraph (2) is not
necessary.
The Gyn Photometer is suitable for the speedy detection of gestational diabetes
and fulfils the requirements of the Maternity Guidelines
2)
and the S3-Directive
3)
.
Glucose can be measured from whole blood as well as from venous plasma. The
displayed measured value is - according to the requirements - always related to
venous plasma.
1)
Guideline of the German Medical Association for the quality assurance of laboratory medical examinations
Deutsches Ärzteblatt | Jg. 116 | Heft 51-52 | 23. Dezember 2019
2)
BAnz. Nr. 36, S914
3)
AWMF-Register Nr. 057/008
7.
Measuring process
7.1 Endpoint measurement
The absorbance is measured after reaching the endpoint.
It is measured against the reagent’s blank count.
Parameters: Haemoglobin SLS (HB SLS), Erythrocytes (ERY), Haematocrit (HCT),
Haemoglobin (HiCN)
Calculation: Concentration = Absorbance x Factor
The erythrocyte and haematocrit counts are determined using stored reference
curves.