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.
|
