BIOLABO

www.biolabo.fr GLUCOSE GOD-PAP

MANUFACTURER:
BIOLABO SAS,
Liquid ready for use
Les Hautes Rives
Reagent for quantitative determination of glucose
02160, Maizy, France
in human serum and plasma, urines or cerebrospinal fluid (CSF)

REF LP80209 R1 2 X 200 mL R2 1 x 5 mL

REF LP87809 R1 8 X 200 mL R2 1 x 5 mL

TECHNICAL SUPPORT AND ORDERS

Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
| IN VITRO DIAGNOSTIC USE
support@biolabo.fr

CLINICAL SIGNIFICANCE (1) (6) STABILITY AND STORAGE

The glucose level in blood is maintained within a fairly narrow range Stored away from light, well cap in the original vial at 2-8°C,
under diverse conditions (feeding, fasting, or severe exercise) by reagents are stable when stored and used as described in the
regulatory hormones such as insulin, glucagon, or epinephrin. insert:
Measurement of glucose is one of the most frequently performed Unopened,
procedures in clinical chemistry laboratories in conjunction with other · Until the expiry date stated on the label of the Kit.
tolerance testing (Glucose tolerance test, Glucose 2h post-prandial…).
Once opened:
The most frequently encountered disorder of carbohydrate metabolism
· Transfer requested quantity, well recap vials and store at 2-8°C,
in blood is hyperglycemia due to diabetes mellitus.
· Reagent (R1) is stable at least 3 months without contamination.
Hyperglycemia higher than 300 mg/dL (16.5 mmol/L) may induce keto-
· Discard reagent (R1) if cloudy or if reagent blank at 500 nm > 0.400.
acidosis and hyperosmolar coma.
In prolonged hypoglycemia, lower than 30 mg/dL (1.7 mmol/L), severe SPECIMEN COLLECTION AND HANDLING (2)
irreversible encephalic damage may occurs.
Serum or plasma:
PRINCIPLE (4) (5) Separate promptly from cells to prevent glycolysis. If fluoride is used
Trinder Method. Glucose is oxidised by GOD to gluconic acid and as a preservative, a decrease of 9 mg/dL (0.5 mmol/L) is seen within
hydrogen peroxide which in conjunction with POD, reacts with chloro- the first 2 hours, then concentration stabilises.
4-phenol and PAP to form a red quinoneimine. The absorbance of the Glucose is stable in serum or heparinised plasma:
coloured complexe, proportional to the concentration of glucose in the
specimen is measured at 500 nm. · for 8 h at 25°C
· for 72 h at 2-8°C
REAGENTS COMPOSITION Glucose is stable in plasma (Sodium fluoride or iodoacetate) :
· for 24 h at room temperature.
R1 GLUCOSE GOD PAP Reagent
CSF:
Phosphate Buffer 150 mmol/L Process immediately to avoid falsely low results. Store at –20°C.
Glucose oxidase (GOD) > 20 000 UI/L Urines:
Peroxidase (POD) > 1000 UI/L
Collect in dark bottle and store at 2-8°C. Preserve 24 h urines with
4-Amino-antipyrine (PAP) 0.8 mmol/L
5 mL glacial acetic acid or 5 g sodium benzoate or sodium fluoride.
Chloro-4-phenol 2 mmol/L

R2 GLUCOSE GOD PAP Standard LIMITES (3)

For a more comprehensive review of factors affecting this assay refer
Glucose 100 mg/dL (5.55 mmol/L) to the publication of Young D.S.
According to 1272/2008 regulation, these reagents are not classified as dangerous

MATERIAL REQUIRED BUT NOT PROVIDED

SAFETY CAUTIONS
1. Basic medical analysis laboratory equipment.
BIOLABO reagents are designated for professional, in vitro diagnostic 2. Spectrophotometer or Biochemistry Clinical Analyzer
use (do not pipette with mouth).
· Refer to current Material Safety Data Sheet available on request or
on www.biolabo.fr
· Verify the integrity of the contents before use.
· Waste disposal: Respect legislation in force in the country.
All specimens or reagents of biological origin should be handled as
potentially infectious. Respect legislation in force in the country.

REAGENTS PREPARATION
Ready for use.

IVD REF LOT ®

Manufacturer Use by In vitro diagnostic Temperature limitation Catalogue number See insert Batch number Store away from light sufficient for dilute with

H2O
Demineralized water Biological hazard

Made in France Latest revision : www.biolabo.fr Revision : 25/02/2019

QUALITY CONTROL CALIBRATION (7)
· BIOLABO EXATROL-N (level I) REF 95010 · REF 95015 BIOLABO Multicalibrator traceable to SRM 965b
· BIOLABO EXATROL-P (level II) REF 95011 · Standard (vial R2)
· REF 95012 Urinary controls The calibration frequency depends on proper instrument functions and
· External quality control program. on the preservation of the reagent.
It is recommended to control in the following cases:
· At least once a run.
· At least once within 24 hours. PROCEDURE
· When changing vial of reagent. Detailed Kenza 240TX procedure is available on request
· After maintenance operations on the instrument.
If control is out of range, apply following actions: Wavelength: 505 nm
1. Repeat the test with the same control. Temperature: 37°C
2. If control is still out of range, prepare fresh control and repeat the Let stand reagents and specimens at room temperature.
test.
3. If control is still out of range, use a new vial of calibrator or a fresh Automated Manual
calibrator and repeat the test. analyzer procedure
4. If control is still out of range, calibrate with a new vial of reagent.
5. If control is still out of range, please contact BIOLABO technical Reagent 300 µL 1000 µL
support or your local Agent.
Standard, Controls, 3 µL 10 µL
EXPECTED VALUES (2) Specimen
Mix. Let stands for 10 minutes at 37°C or 20 minutes at room
GLUCOSE in serum or plasma :
temperature.
Population mg/dL [mmol/L] Read absorbance at 500 nm (460-560) against reagent blank.
Newborn, 1 day 40-60 [ 2.2-3.3 ] Coloration is stable for 15-20 minutes at 37°C, and then slowly
Newborn > 1 day 50-80 [ 2.8-4.4 ] decreases.
Children 60-100 [ 3.3-5.6 ]
Adult 74-106 [ 4.1-5.9 ] Notes:
60-90 years 82-115 [ 4.6-6.4 ] 1- For urines, use standard of the kit to calibrate and control with
> 90 years 75-121 [ 4.2-6.7 ] REF 95012
2- Performances and stability data’s have been validated with serum on
In CSF : mg/dL [mmol/L] KENZA 240TX and KENZA 450TX
Infant, Child 60-80 [ 3.3-4.4 ] 3-With Manual Procedure on Spectrophotometer and on other
Adult 40-70 [ 2.2-3.9 ] automated analyzers, performances and stability should be validated by
user.
In 24 h urines : 1-15 mg/dL [0.1-0.8 mmol/L] 4- Applications proposal are available on request
< 0.5 g/24 hours [<2.78 mmol/24 hours]
Each laboratory should establish its own normal ranges for the
population that it serves. CALCULATION

Calculate the result as follows:

PERFORMANCES at 37°C on KENZA 240TX
Linearity Range: between 8 and 500 mg/dL Result = Abs (Assay) x Standard concentration
Detection limit: approx. 2 mg/dL Abs (Standard)
Precision:
Within-run Low Normal High Between run Low Normal High REFERENCES
N = 20 level level level N = 20 level level level (1) TIETZ Textbook of clinical chemistry. 3rd Ed. C.A. Burtis. E.R. Ashwood.
W.B. Saunders (1999) p. 750-785.
Mean (mg/dL) 36 108 300 Mean (mg/dL) 36 108 291 (2) Clinical Guide to Laboratory Test. 4th Ed.. N.W. TIETZ (2006) p. 444-451
S.D. mg/dL 0.7 1.8 3.2 S.D. mg/dL 0.7 2.1 4.0 (3) YOUNG D.S.. Effect of Drugs on Clinical laboratory Tests. 4th Ed. (1995)
p. 3-274 to 3-294.
C.V. % 1.9 1.7 1.1 C.V. % 2.0 1.9 1.4 (4) FARRANCE I. Clin. Biochem. reviews (1987). 8. p.55 to 68.
(5) TRINDER P.. Ann. Clin. Biochem.(1969). 6. p.24-27.
Comparison studies on Spectrophotometert with commercially (6) BERNARD S., Biochimie clinique, 2cde éd.,Edition Maloine (1989),
available reagent: p.165-167.
Realised on serum specimens (n=61) between 24 and 357 mg/dL (7) SRM : Standard Reference Material ®
y = 0.969 x + 1.33 R= 0.9984
Analytical Sensitivity: approx. 0.060 abs for 10 mg/dL
Interferences:
Turbidity Positive interference from 0.181 OD
Total bilirubin Negative interference from 337 µmol/L
Direct bilirubin Negative interference from 190 µmol/L
Ascorbic acid Negative interference from 360 mg/dL
Haemoglobin Positive interference from 228 µmol/L
Other substances may interfere (see § Limits)
On the board stability: 2 months
Calibration Stability: 2 months
Make a new calibration when changing reagent batch, if quality control
results are found out of the established range and after maintenance
operations

Made in France Latest revision : www.biolabo.fr Revision : 25/02/2019

 H-1117 Budapest,
GLUCOSE GOD/PAP
Budafoki street 111-113 STABLE LIQUID REAGENT
Tel.: +36-1-205-3617 Cat. No.: 46861,46861S 46862,46862S 46863
120 ml 600 ml 20x20 ml
Tel./Fax: +36-1-205-3616

Reagent kit for the quantitative determination of glucose concentration in serum and Calculation
liquor. Enzymatic colorimetric method (GOD/POD/PAP).
Asample
Determination of glucose concentration is important in the diagnosis and treatment of
xC standard = C sample
disorders of carbohydrate metabolism. Values higher or lower than the reference are of
Astandard
diagnostic significance. The levels are increased in diabetes mellitus, hyperthyroidism and A = Absorbance C=Concentration
in the hyperactivity of the pituitary gland. Decreased levels are observed in cases of Quality control
overproduction of insulin by the pancreas, with tumors of the pancreas, as well as with A quality control program is recommended for all clinical laboratories. The analysis of
hypofunction of the organs involved in glucose synthesis and carbohydrate metabolism. control material in both the normal and abnormal ranges with each assay is recommended
for monitoring the performance of the procedure. Each laboratory should establish
Principle corrective measures to be taken if values fall outside the limits.
Glucose oxidase (GOD) converts the sample Glucose into gluconate. The
Hydrogenperoxide (H2O2) produced in the reaction is degraded by peroxidase (POD) and
PERFORMANCES DATA
gives a colored product Phenol and 4-Aminoantipyrine which is measurable using Trinder
indicator reaction at 505 nm. The increase in absorbance correlates with the glucose
The following data were obtained using the Olympus 400 analyzer (37°C).
concentration of the sample.

Glucose+O2 
→ GOD
Gluconic acid+H2O2 Linearity
The test is linear up to 40 mmol/l (720 mg/dl) glucose concentration.
2H2O2+Phenol+4-Aminoantipyrine 
→ Red quinone+4H O
POD
2
Sensitivity
It is recommended that each laboratory establishes its own range of sensitivity as this is
Reference values
limited by the sensitivity of the spectrophotometer used. Under manual conditions
Serum: 3.89-5.84 mmol/l (70-105 mg/dl)
however, a change of 0.001 Abs is equivalent to 0.019 mmol/l (0,34mg/dl) Glucose
Cerebrospinal fluid: 2.78-3.89 mmol/l (50-70 mg/dl)
concentration at 492 nm.
It is recommended that each laboratory should assign its own normal range.
Precision
Reagents
1. Reagent (R1)
Phosphatase buffer, pH:7.40 100 mmol/l Reproducibility
Phenol 10 mmol/l Sample Average concentration (mmol/l) SD CV%
4-Aminoantipyrine 0.3 mmol/l
Glucose oxidase 10000 U/l sample I 5.54 0.08 1.47
Peroxidase 700 U/l sample II 13.9 0.16 1.17
2. Glucose standard
Ready for use.For details please check the insert.
Repeatability
Available only in Cat. No.: 46861S and 46862S
Sample Average concentration (mmol/l) SD CV%
Precautions sample I 4.5 0.04 0.88
Discard cloudy reagent. Avoid contamination by using clean laboratory material (pipettes,
plastic vials for analyzers, ...). sample II 15.4 0.12 0.75
The reagent contains sodium azide (0.1 %). To avoid the possible build-up of azide
compounds, flush waste-pipes with water after the disposal of undiluted reagent. Correlation
Comparative studies were done to compare our reagent with another commercial Glucose
Sample PAP reagent. The results from these studies are detailed below.
Serum free of haemolysis. Correlation coefficient: r = 0.9999
Cerebrospinal fluid. Linear regression: y (mmol/l)= 0.980x+0.099
(x= other commercial reagent, y= own reagent).
PROCEDURE
Specificity
Bilirubin 855 µmol/l (50 mg/dl), lipid 1000 mg/dl and ascorbic acid 0.14 mmol/l (25
Preparation and stability of working reagent
The reagent is ready for use.
mg/dl) don’t interfere with the assay up to the given levels.
If the absorbance of working reagent is higher than 0.1 at 492 nm the reagent can not be
used.
Note
With this assay the determination of glucose concentration in urine is not acceptable,
Assay conditions
because ascorbic acid influences the measurement. The reference method of glucose
Wavelength: 505 (492-520) nm
determination is the hexokinase and the glucose-6-phosphate-dehydrogenase (HK/G-6-
Temperature: 37 °C
PDH) UV test (It is also suitable for the determination of glucose concentration in urine).
Cuvette: 1 cm light path
Do not use reagents after the expiry date stated on each reagent container label. Do not use
Method: endpoint (increasing)
products, test solutions and reagents described above for any purpose other than described
Read against: reagent blank
herein.
Pipette into cuvette
Blank Standard Sample For in vitro diagnostic use only.
Working reagent 1 ml 1 ml 1 ml
The following symbols are used on labels
Distilled water 10µl
Standard 10µl
Sample 10µl For in vitro diagnostic use
Mix and measure the absorbance (A) after a five-minute incubation.
Use by (last day of the month)
Calibration (37°C, GOD/PAP test)
S1: Distilled water
S2: Glucose standard Cat. No.: 50411 or Temperature limitation
Roche C.F.A.S. (Calibrator for automated system)
Randox Calibration Serum Level I or Batch Code
Randox Calibration Serum Level II
Code
Calibration frequency
Two-point calibration is recommended:
- after reagent lot change,
Bibliography
- as required following quality control procedures.
Trinder P,: Ann. Clin. Biochem. 6,(1969),24.

Glucose GOD/PAP stable liquid reagent Date of revision: 2013-02 68-EN-2013-09

 INSTRUKSI
NO. DDK
001/5 001/IK/RS-MN/XI/2021
KERJA
PEMERIKSAAN NO. REVISI 01
KADAR
GLUKOSA TANGGAL 2 November 2021
DARAH METODE
GOD-PAP HALAMAN 1/4
DITETAPKAN
DIREKTUR RS MN MEDIKA PALEMBANG

RS MN
MEDIKA
PALEMBANG

dr. Maulidyah Nur, Sp.PK

NIP: 20020528 202505 1 005

I. PELAKSANAAN Petugas ATLM

II. PRINSIP Glukosa oksidase (GOD) mengubah glukosa sampel menjadi
glukonat. Hidrogenperoksida (H2O2) yang dihasilkan dalam
reaksi didegradasi oleh peroksidase (POD) dan memberikan
produk berwarna Phenol dan 4-Aminoantipyrine yang dapat
diukur menggunakan Trinder reaksi indikator pada 505 nm.
Peningkatan absorbansi berkorelasi dengan glukosa konsentrasi
sampel.
Glucose+O2¾¾¾® GOD
Gluconic acid+H2O2
2H2O2+Phenol+4-Aminoantipyrine¾¾¾® POD
Red quinone+4H2O
III. METODE GOD-PAP
IV. SAMPLE
(i) Jenis Serum/plasma bebas dari hemolisis/cairan
serebrospinal/CSF/Urine
(ii) Jumlah 1000µl
(iii) Stabilitas Serum atau plasma: 25°C selama 8 jam / 2-8°C selama 72 jam
Cairan serebrospinal/CSF: segera dikerjakan / simpan pada -20°C.
Urine : 2-8°C selama 24 jam dengan 5 mL asam asetat glasial atau
5 g natrium benzoat atau natrium fluorida.
V. REAGEN
(i) Jenis R1 Reagen Glukosa GOD PAP =
Phosphate Buffer 150 mmol/L
Glucose oxidase (GOD) > 20 000 UI/L
Peroxidase (POD) > 1000 UI/L
4-Amino-antipyrine (PAP) 0.8 mmol/L
Chloro-4-phenol 2 mmol/L
R2 Standar Glukosa GOD PAP =
Glucose 100mg/dL (5.55 mmol/L)
(ii) Penyimpanan 2-25°C R1 dan R2 stabil bahkan setelah dibuka
sampai tanggal kadaluwarsa
VI. KONTROL
(i) Jenis Kontrol normal dan Kontrol abnormal
(ii) Penanganan Buka tutup botol hati-hati dan pipet dengan tepat 5 ml aquabidest
kemudian botol ditutup dan campursecara perlahan selama 30
menit, dan hindari terbentuknya busa.
 INSTRUKSI
NO. DDK
001/5 001/IK/RS-MN/XI/2021
KERJA
PEMERIKSAAN NO. REVISI 01
KADAR
GLUKOSA TANGGAL 2 November 2021
DARAH METODE
GOD-PAP HALAMAN 2/4
DITETAPKAN
DIREKTUR RS MN MEDIKA PALEMBANG

RS MN
MEDIKA
PALEMBANG

dr. Maulidyah Nur, Sp.PK

NIP: 20020528 202505 1 005

(iii) Penyimpanan 2-8°C dalam bentuk lyophilisate sampai dengan waktu tanggal
kadaluarsa. Kontrol yang sudah dilarutkan stabil pada suhu :
25°C selama 12 jam, 4°C selama 5 hari
20°C selama 1 bulan (tidak beku ulang)
VII. KALIBRATOR
(i) Jenis S1: Air suling
S2: Standar glukosa Cat. No.: 50411 atau
Roche C.F.A.S. (Kalibrator untuk sistem otomatis)
Serum Kalibrasi Randox Level I atau
Serum Kalibrasi Randox Level II
(ii) Penanganan Buka botol dengan hati-hati dan tambahkan larutan. Kemudian
botol ditutup dan diamkan selama 30 menit. Campur perlahan
untuk mencegah terbentuknya busa.
(iii) Penyimpanan 2-8°C dalam bentuk lyophilisate sampai dengan waktu tanggal
Kadaluarsa
25°C selama 12 jam, 4°C selama 5 hari
20°C selama 1 bulan (tidak beku ulang)
VIII. ALAT Photometer 4020
Mikropipet 100uL, 1000uL
Blue Tip dan Yellow Tip
Tabung Reaksi
Rak Tabung
Sentrifugal
IX. LANGKAH 1.Pemrograman Alat
KERJA • Menyalakan alat dan tunggu hingga alat siap
• Mengatut tanggal pemeriksaan pada alat
• Tekan nomor pemeriksaan pada alat (misal no 5 untuk
pemeriksaan glukosa)
• Mengatur panjang gelombang pada 500 nm
2. Mengerjakan Blank
• Pipet 1000uL RGT warna Glukosa
• Masukkan Ke dalam tabung reaksi
• Inkubasi selama 10 menit dengan suhu 20-25°C atau 5 menit
pada suhu 37°C
• Masukkan pada photometer 4020 ketika terdapat perintah sip
reagen blank
 INSTRUKSI
NO. DDK
001/5 001/IK/RS-MN/XI/2021
KERJA
PEMERIKSAAN NO. REVISI 01
KADAR
GLUKOSA TANGGAL 2 November 2021
DARAH METODE
GOD-PAP HALAMAN 3/4
DITETAPKAN
DIREKTUR RS MN MEDIKA PALEMBANG

RS MN
MEDIKA
PALEMBANG

dr. Maulidyah Nur, Sp.PK

NIP: 20020528 202505 1 005

3. Mengerjakan Kontrol atau Standard

• Pipet 1000 uL RGT Warna Glukosa dan 10 uL RGT Standard
• Glukosa
• Masukkan ke dalam tabung reaksi • Inkubasi selama 10 menit
dengan suhu 20-25°C atau 5 menit
• pada suhu 37°C
• Masukkan pada alat photometer 4020 ketika terdapat perintah
• sip reagen standard
4. Mengerjakan Sampel
• Pipet 1000uL RGT Warna Glukosa dan 10 uL sampel atau
serum
• Masukkan ke dalam tabung reaksi • Inkubasi 10 menit dengan
suhu 20-25°C atau 5 menit pada suhu 37°C
• Masukkan pada alat photometer 4020 ketika terdapat perintah
sip sampel
5. Linearity
• Tes ini linear hingga konsentrasi glukosa 400 mg/dL atau 22,2
mmol/L.
• Encerkan sampel 1 : 2 dengan aquadest, jika konsentrasi
glukosa dari sampel masih melebihi batas ini ulangi
pengenceran dan hasilnya dikalikan tiga
X. PERHITUNGAN 𝐴𝑏𝑠𝑜𝑟𝑏𝑎𝑛𝑐𝑒 𝑡𝑒𝑠𝑡
x Konsentrasi standar (g/dL)
𝐴𝑏𝑠𝑜𝑟𝑏𝑎𝑛𝑐𝑒 𝑆𝑡𝑎𝑛𝑑𝑎𝑟𝑑
HASIL
XI. NILAI RUJUKAN Serum: 3.89-5.84 mmol/l (70-105 mg/dl)
Cerebrospinal fluid: 2.78-3.89 mmol/l (50-70 mg/dl)
XII. CATATAN Dengan uji ini penentuan konsentrasi glukosa dalam urin tidak
dapat diterima,karena asam askorbat mempengaruhi pengukuran.
Metode referensi glukosa penentuannya adalah heksokinase dan
glukosa-6-fosfat-dehidrogenase (HK/G-6-PDH) tes UV (Hal ini
juga cocok untuk penentuan konsentrasi glukosa dalam urin).
Jangan menggunakan reagen setelah tanggal kedaluwarsa yang
tertera pada setiap label wadah reagen. Jangan gunakan produk,
larutan uji, dan reagen yang dijelaskan di atas untuk tujuan apa
pun selain yang dijelaskan disini.
 INSTRUKSI
NO. DDK
001/5 001/IK/RS-MN/XI/2021
KERJA
PEMERIKSAAN NO. REVISI 01
KADAR
GLUKOSA TANGGAL 2 November 2021
DARAH METODE
GOD-PAP HALAMAN 4/4
DITETAPKAN
DIREKTUR RS MN MEDIKA PALEMBANG

RS MN
MEDIKA
PALEMBANG

dr. Maulidyah Nur, Sp.PK

NIP: 20020528 202505 1 005

Daftar Pustaka http://www.biolabo.fr/biolabo/pdfs/noticesE/biochimieE/AT-

80209LP.pdf

http://clinichem.hu/documents/Glucose_PAP_stable_liquid+standard.p
df
Siti Qomariah Anisa, S.Tr. Kes
Dibuat oleh
Koordinator Laboratorium
Amirah L, SKM., M.Kes
Disetujui oleh
Kepala Laboratorium