BEACON CONTROL NORM & PATH

(BIOCHEMISTRY)
Code Product Name Pack Size
LP010B Beacon Control Norm & Path 6x1 ml

INTENDED USE
This product is intended for in vitro diagnostics use in the quality control of PREPARATION FOR USE
diagnostic assay. This Beacon Control Norm & Path is for the control of The Beacon Control Norm & Path is supplied lyophilised.
accuracy.
1. Carefully reconstitute each vial of lyophilised serum with exactly 1 ml of
DEVICE DESCRIPTION distilled water at +15°C to +25°C. Close the bottle and allow to stand for 30
The Beacon Control is supplied at 2 levels, Beacon Control Norm and Beacon minutes before use. Ensure contents are completely dissolve by swirling
Control Path. Target values and ranges are supplied for the analytes listed in gently. Avoid formation of foam. Do not shake.
value section at both levels.
2. Refer to the Control section of the individual analyser application.
SAFETY PRECAUTIONS AND WARNING
For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal 3. Refrigerate any unused material. Prior to use, mix contents thoroughly.
precautions required for handling laboratory.
MATERIALS PROVIDED
Human source material from which this product has been derived has been
tested at donor level for the Human Immunodeficiency Virus (HIV I, HIV 2) Beacon Control Norm & Path 6x1 ml
antibody, Hepatitis B Surface Antigen (HbsAg) and Hepatitis C Virus (HCV)
antibody and found to be NON-REACTIVE. FDA approved methods have
been used to conduct these tests. MATERIALS REQUIRED BUT NOT PROVIDED
However, since no method can offer complete assurance as to the absence of Volumetric Pipette
infectious agents, this material and all patient samples should be handled as Distilled Water
though capable of transmitting infectious disease and disposed of
accordingly.
WASTE MANAGEMENT
Health and Safety Data Sheet are available on request. Please refer to local legal requirements.

STORAGE AND STABILITY

OPEN : Store refrigerated (+2°C to +8°C). Reconstituted serum is stable

for 8 hours at +15°C to +25°C or 7 days at +2°C to 8°C, and 1 month
when frozen once at -20°C (See limitations).

UNOPEN :Store refrigerated (+2°C to +8°C). Stable to expiration date printed

on individual vials.

LIMITATIONS
For Total & Prostatic Acid Phosphatase, the materials should be stabilised
adding 1 drop (25 - 30) of 0.7 M Acetic acid solution to 1 ml of the serum
exactly 30 minutes after reconstitution. After stabilisation Total and Prostatic
Acid Phosphatase is stable for 2 hours at +15°C to +25°C, 2 days at +2°C to
+8°C nd 1 month when frozen once at -20C.
Alkaline Phosphatase levels in the reconstituted serum will rise over the
stability period. It is recommended that the reconstituted serum be allowed to
stand for 1 hour at +15°C to +25°Cbefore measurement.
The reconstituted stability for ALT is 5 days, when stored at +2°C to +8°C. The
ALT is stable for 8 hours at +15°C to +25°C, and 28 days when frozen once at -
18°C to 24°C.
Bilirubin in the serum is light sensitive and it is recommended that the serum
be stored in the dark. Stored in the dark, it is stable for 4 days at +2°C to +8°C.
Do not store at +15°C to +25°C. Do not freeze.
NEFA is stable for 1 day at +2°C to +8°C.
Total PSA is stable for 4 days at +2°C to +8°C, or 28 days in aliquots frozen at -
18°C to -24°C.
Bacterial contamination of the reconstituted serum will cause reduction in the
stability of many components.
Different lot number of this control should not be interchanged, as the
assigned to the controls vary from lot to lot.
The control should not be used as a calibration materials.
The reconstituted stability for Beacon Control Norm for Iron, Alkaline
Phosphatase (ALP) and Alanine Amino Transferase (ALT) is 3 days, when
stored at +2°C to +8°C.
ALP, ALT and Iron are stable for 8 hours at +15°C to +25°C, and 28 days when
frozen once at -18°C to -24°C.
Alkaline Phosphatase levels in the reconstituted serum will rise over the stability
period. It is recommended that the reconstituted serum be allowed to stand for 1
hour at +15°C to +25°C before measurement.
 Lot No. : LP10-007
Mfg. : DEC-2022
Exp. : NOV-2024

BEACON CONTROL NORM BEACON CONTROL PATH

Range Range
Analytes Unit Target Low High 1 SD 2 SD Target Low High 1 SD 2 SD Method
g/dl 4.27 3.63 4.91 0.32 0.64 2.96 2.52 3.40 0.22 0.44
Albumin Bromocresol Green Method
g/l 42.7 36.3 49.1 3.20 6.40 29.6 25.2 34.0 2.20 4.40
Alkaline Phosphatase U/L 190 162 218 14.00 28.00 342 291 393 25.5 51 AMP Optimized IFCC 37°C
Amylase U/L 99 84 114 7.50 15.00 345 293 397 26 52 Direct Substrate Method
mg/dl 0.761 0.603 0.919 0.08 0.15 1.61 1.28 1.94 0.17 0.33
Bilirubin (Direct) DMSO Method
µmol/l 12.99 10.31 15.71 1.40 2.80 27.53 21.88 33.17 2.82 5.64
mg/dl 1.48 1.15 1.77 0.14 0.28 5.06 4.00 6.12 0.53 1.06
Bilirubin (Total) DMSO Method
µmol/l 25.30 19.66 30.26 2.65 5.30 86.5 68.3 105 9.1 18.2
mg/dl 9.06 8.14 9.98 0.46 0.92 12.8 11.5 14.1 0.65 1.30
Calcium Arsenazo III Method
mmol/l 2.26 2.03 2.49 0.12 0.23 3.19 2.87 3.51 0.16 0.32
Chloride mmol/l 103 94.8 111 4.10 8.20 116 107 125 4.5 9 Colorimetric Method
mg/dl 155 135 175 10.00 20.00 273 237 309 18 36
Cholesterol CHOD/POD Method
mmol/l 4.01 3.49 4.53 0.26 0.52 7.07 6.15 7.99 0.46 0.92
CK NAC U/L 194 159 229 17.5 35.00 507 416 598 45.5 91 Optimized IFCC 37°C
mg/dl 1.56 1.24 1.88 0.16 0.32 4.33 3.46 5.20 0.44 0.87
Creatinine Enzymatic Method
µmol/l 138 110 166 14.00 28.00 383 306 460 38.5 77
Gamma GT U/L 51 43 59 4.00 8.00 168 143 193 12.5 25 SASZ Method
mg/dl 110 93.7 126 8.15 16.30 281 240 322 20.5 41
Glucose GOD/POD Method
mmol/l 6.12 5.20 7.04 0.46 0.92 15.6 13.3 17.9 1.15 2.3
mg/dl 51 43.2 58.8 3.90 7.80 77.2 65.6 88.8 5.8 11.6
HDL Direct PEGME Method
mmol/l 1.32 1.12 1.52 0.10 0.20 2.0 1.7 2.3 0.15 0.3
mg/dl 70 60 80 5 10 140 122 158 9.00 18.00
LDL Direct Detergent Method
mmol/l 1.81 1.55 2.07 0.12 0.25 3.62 3.16 4.09 0.23 0.46
Lipase U/L 29 23 35 3 6 53 42 64 5.5 11 Methyl Resorufin Method
LDH U/L 199 169 229 15 30 360 306 414 27 54 L-P Kinetic Method
mg/dl 2.20 1.94 2.46 0.13 0.26 4.35 3.82 4.88 0.27 0.53
Magnesium XB Method
mmol/l 0.91 0.80 1.02 0.05 0.11 1.79 1.57 2.01 0.11 0.22
mg/dl 4.56 3.88 5.24 0.34 0.68 6.88 5.83 7.93 0.53 1.05
Inorganic Phosphorous Molybdate UV Method
mmol/l 1.47 1.25 1.69 0.11 0.22 2.22 1.88 2.56 0.17 0.34
Potassium mmol/l 4.21 3.87 4.55 0.17 0.34 6.08 5.59 6.57 0.25 0.49 Colorimetric Method
SGOT U/L 35 28 42 3.5 7.00 150 120 180 15 30 IFCC Method
SGPT U/L 36 29 43 3.5 7.00 138 111 165 13.5 27 IFCC Method
Sodium mmol/l 143 136 150 3.5 7.00 162 154 170 4 8 Colorimetric Method
g/dl 5.91 4.73 7.09 0.59 1.18 4.49 3.59 5.39 0.45 0.90
Total Protein Biuret Method
g/l 59.1 47.3 70.9 5.9 11.8 44.9 35.9 53.9 4.50 9.00
mg/dl 100 84.3 116 7.85 15.7 258 218 298 20.00 40.00
Triglycerides GPO/POD Method
mmol/l 1.13 0.95 1.31 0.09 0.18 2.92 2.46 3.38 0.23 0.46
mg/dl 43.7 37.1 50.3 3.3 6.6 117 99.8 134 8.60 17.2
Urea UV GLDH Method
mmol/l 7.27 6.18 8.36 0.55 1.09 19.5 16.6 22.4 1.45 2.90
mg/dl 5.86 5.11 6.61 0.38 0.75 9.39 8.16 10.6 0.62 1.23
Uric Acid Uricase / POD Method
mmol/l 0.35 0.30 0.39 0.02 0.05 0.56 0.49 0.63 0.04 0.07

SYMBOLS USED ON LABELS

REF Catalogue Number Manufacturer See Instruction for Use

LOT Lot Number CONT Content Storage Temperature

Expiry Date IVD In Vitro Diagnostics

BEA/24/BNP/LP/IFU-03 DATE :12.08.2022