Tuesday, May 19, 2020

Biorad & Randox - QC Product Comparison Review (Lyophilized Clinical Chemistry Control)

BIORAD RANDOX QC


Biorad(USA) & Randox (UK) QC are preferred third party Internal Quality Control (IQC) materials in worldwide. They are major key players in the global IVD quality control market. Herewith provided comparison review of Lyophilized Clinical Chemistry Control Material based on product details & kit literature published in their webportal.

The comparison will be useful for Lab Directors,Clinical Biochemists,Medical Biochemists & Medical laboratory professionals to choose easily their QC materials according to Equipment & Test Scope.

S.No
Particulars
Biorad (USA)
Randox (UK)
1.      
Product Name
Lyphochek - Assayed Chemistry Control
Acusera – Assayed Chemistry Premium Plus Control
2.      
Product Code
Level 1 : C-310-5
Level 2 : C-315-5
Bilevel MiniPak : 313X
Level 2 : HN1530
Level 3 : HE1532
Level 2 & Level 3 : HS2611
3.      
Matrix Type
Human Serum ,
Lyophilized
Human Serum,
Lyophilized
4.      
QC Levels
Level 1 (Normal),
Level 2 (Abnormal)
Level 2 (Normal),
Level 3 (High)
5.      
Available Pack Sizes
12 × 5 mL – Level 1
12 × 5 mL – Level 2
02 × 5 mL – Level 1 & Level 2
20× 5 mL – Level 2
20× 5 mL – Level 3
2× 5×5 mL – Level 2 & Level 3
6.      
Shelf life
3 Years
4 Years
7.      
Reconstituted Stability @ 15ºC
Not Provided
8 hours
8.      
Reconstituted Stability @ Refrigeration (2-8 ºC)
7 Days
 Except :
- T3 (Free), Acid Phosphatase (Total) and Prostatic Acid Phosphatase (PAP) – 3 Days
7 Days
 Except:
- Bilirubin & Total PSA – 4 days
- NEFA – 1 day
9.      
Reconstituted Stability @ Frozen (-10 to - 20ºC)
30 Days
 Except :
- Tobramycin : 20 Days
- T3 (Free) : 10 Days
28 Days
 Note :
After stabilization Total and Prostatic Acid Phosphatase is stable for 2 hours at +15°C to +25°C, 2 days at +2°C to +8°C, and 28 days when frozen once at –18°C to –24°C.
10.   
Reconstituting Material
Distilled Water
Distilled Water
11.   
QC Target/Range
+/- 3 SD
+/- 2SD
12.   
Total No of Analytes
80 Analytes
70 Analytes




S.No
ANALYTES LIST
Biorad (USA)
Lyphochek - Assayed Chemistry Control
Randox (UK)
Acusera – 
Assayed Chemistry Premium Plus Control
1.      
Alpha-1-Antitrypsin
2.      
Alpha-1-Globulin (Electrophoresis)
3.      
Alpha-2-Globulin (Electrophoresis)
4.      
Alpha-Hydroxybutyrate Dehydrogenase (αHBDH)
5.      
Acetaminophen

6.      
Acid Phosphatase (Total)
7.      
Acid Phosphatase (Prostatic)
8.      
Acid Phosphatase (Non-Prostatic)
9.      
Alphafetoprotein (AFP)
10.   
Albumin
11.   
Albumin (Electrohoresis)
12.   
Alkaline Phosphatase (ALP)
13.   
ALT/SGPT
14.   
Amylase
15.   
Amylase (Alpha)
16.   
Amylase (Pancreatic)
17.   
Apolipoprotein A-1
18.   
Apolipoprotein B
19.   
AST/SGOT
20.   
Beta-1-Globulin (Electrophoresis)
21.   
Bile Acids
22.   
Bilirubin (Direct)
23.   
Bilirubin (Indirect)
Bilirubin (Total)
24.   
Calcium
25.   
Calcium (Ionized)
26.   
Carbamazepine
27.   
CEA
28.   
Ceruloplasmin
29.   
Chloride
30.   
Cholesterol (HDL)
31.   
Cholesterol (LDL)
32.   
Cholesterol (Total)
33.   
Cholinesterase
34.   
CO2
35.   
Complement C3
36.   
Complement C4
*
37.   
Copper
38.   
Cortisol
39.   
Creatine Kinase (CK)
40.   
Creatinine
41.   
D-3-Hydroxybutyrate
42.   
Digoxin
43.   
Folate
44.   
Gentamicin
45.   
GGT
46.   
GLDH
47.   
Globulin
48.   
Gamma-Globulin (Electrophoresis)
49.   
Glucose
50.   
Haptoglobin
51.   
hCG-β Subunit
52.   
Immunoglobulin A (IgA)
53.   
Immunoglobulin G (IgG)
54.   
Immunoglobulin M (IgM)
55.   
Iron
56.   
Iron (UIBC)
57.   
Lactate (Lactic Acid)
58.   
LAP-Arylamidase
59.   
LDH
60.   
Lipase
61.   
Lithium
62.   
Magnesium
63.   
NEFA
64.   
Osmolality
65.   
Paracetamol
66.   
PAP
67.   
Phenobarbital
68.   
Phenytoin
69.   
Phosphorus
70.   
Potassium
71.   
Protein Electrophoresis
72.   
Protein Total
73.   
Protein (Total) PSA
74.   
Salicylate
75.   
Sodium
76.   
T3 (Free)
77.   
T3 (Total)
78.   
T3 Uptake/T-Uptake
79.   
T4 (Free)
80.   
T4 (Total)
81.   
TBG
82.   
Theophylline
83.   
Tobramycin
84.   
Transferrin
85.   
Triglycerides
86.   
Thyroid Stimulating Hormone (TSH)
87.   
TIBC
88.   
Urea
89.   
Urea Nitrogen
90.   
Uric Acid
91.   
Valproic Acid
92.   
Vancomycin
93.   
Vitamin B12
94.   
Zinc


Note :  * No Claim is made for expected value or stability





S.No
INSTRUMENTS LIST
Biorad (USA)
Lyphochek - 
Assayed Chemistry Control
Randox (UK)
Acusera – 
Assayed Chemistry Premium Plus Control
1.      
ABAXIS-PICCOLO
2.      
ABX PENTRA 400
3.      
ABBOTT ARCHITECT cSYSTEMS
4.      
BECKMAN COULTER ACCESS / 2 / 2i
5.      
BECKMAN COULTER AU SYSTEMS
6.      
BECKMAN COULTER SYNCRON/UniCel DxC SERIES
7.      
BIOSYSTEMS A15
8.      
BIOSYSTEMS A25
9.      
BIOTECHNICA/WIENER BT & CB SERIES
10.   
ELITECH/VITALAB SELECTRA SERIES
11.   
ILAB 600 /650 /ARIES/TAURUS
12.   
KONELAB 20/30/60/THERMO SCIENTIFIC INDIKO PLUS
13.   
MINDRAY BS-200/300/400
14.   
ORTHO VITROS SERIES
15.   
ROCHE / HITACHI COBAS C SYSTEMS
16.   
ROCHE COBAS INTEGRA
17.   
RANDOX RX SERIES
18.   
SIEMENS ADVIA CENTAUR CP
19.   
SIEMENS ADVIA CENTAUR SYSTEMS
20.   
SIEMENS ADVIA CHEMISTRY SYSTEMS
21.   
SIEMENS ATELLICA CHEMISTRY SYSTEMS
22.   
SIEMENS BN SERIES NEPHELOMETERS
23.   
SIEMENS DIMENSION SERIES
24.   
SIEMENS DIMENSION VISTA SYSTEMS
25.   
SIEMENS IMMULITE / IMMULITE 1000
26.   
SIEMENS IMMULITE 2000 / 2000 XPi


Note: Target Values can be obtained from “Method List” for Equipment not listed.
Note: Target Values can be obtained from “Mean of All Instruments” for Equipment not listed.

Source Reference :
https://www.bio-rad.com/
https://www.randox.com/




POSTED BY: 

Mr.V.SELVAM, M.Sc (Biochemistry)
Consultant - ISO 9001 & NABL (ISO 15189 & ISO 17025)
Chennai, Tamilnadu, India
+91-9940014466

4 comments:

selvam.mindemits@gmail.com