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
- T3 (Free), Acid Phosphatase (Total) and Prostatic Acid
Phosphatase (PAP) – 3 Days
|
7 Days
- Bilirubin & Total PSA – 4 days
- NEFA – 1 day
|
9.
|
Reconstituted Stability @ Frozen
(-10 to - 20ºC)
|
30 Days
- Tobramycin : 20 Days
- T3 (Free) : 10 Days
|
28 Days
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.
|
Mr.V.SELVAM, M.Sc (Biochemistry)
Consultant - ISO 9001 & NABL (ISO 15189 & ISO 17025)
Chennai, Tamilnadu, India
✆ +91-9940014466

Great sir!!
ReplyDeleteThank You
DeleteThank you. May I know your name.
DeleteBio-Rad is the best using it for the past 20 yrs
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