Test Protocols VIDAS® / mini VIDAS® Units VIDAS

advertisement
Test Protocols
VIDAS® / mini VIDAS®
Units
VIDAS® / mini VIDAS®
Compatible assays
01-13 / 9300651/008/ KR/A / This document is not legally binding. bioMérieux reserves the right to modify specifications without notice / BIOMERIEUX, the blue logo, VIDAS and D-Dimer Exclusion are used, pending and/or registered trademarks
belonging to bioMérieux S.A. or one of its subsidiaries / bioMérieux SA RCS Lyon 673 620 399 / Photos: N. Bouchut, bioMérieux / Printed in France / THERA Conseil / RCS Lyon B 398 160 242
VIDAS test
TSH
T4
TSH3
FT3
FT4N
CORS
ATPO
ATG
T3
CKMB
TNIU
PBNP
PBNP2
PCT
MYO
DEX2
PC
HCG
FER
Ig E
AFP
STA
ST
STO (1)
SE1 - SE2 - SM6 - SD1
SD2 - SW21 - SW6 - SG6
SG3 - ST9 - ST3 - ST6 - SK82
SI6 - SF85 - SF4 - SF3
SF14 - SF1 - SF2 -
E2II
TEST
PRL
LH
FSH
PRG
CEAS
199
125
TPSA
FPSA
153
CDAB
HIV5
HIV6
Only parameters for which results can be expressed in different units are given in this table.
Sample volume
200 µl
200 µl
200 µl
100 µl
100 µl
100 µl
250 µl
200 µl
150 µl
150 µl
200 µl
100 µl
100 µl
100 µl
200 µl
200 µl
200 µl
2 LH
200 µl
200 µl
200 µl
100 µl
200
VIDAS test
Sample volume
P24
P24 confirmation test
MPG
VZG
MSG
RBM
TXC
TXGA (0)
TXG
TXM
RBG
B2M
LYT
CMVG
CMVU
HPY
CMVM
HBCM II
HBS
HBS confirmation test
HBST
HBCT II
HAVT
HBE
HBL
HBL confirmation test
HBET
HAVM
LYM
LYG
LYGS
VCAG
VCAM
EBNA
100 µl
300 µl *
200 µl
200 µl
200 µl
200 µl *
100 µl
100 µl
125 µl
2 x 100 µl
100 µl
µl
100
Parameter Proposed
Code
VIDAS Unit
E2II
FT4
T4
FT3
2 x 100 µl
100 µl
100 µl
100 µl
150 µl
150 µl *
150 µl
150 µl
150 µl
150 µl
150 µl
T3
150 µl *
150 µl *
150 µl *
100 µl
PRL
100 µl
FER
CORS
B2M
100 µl
100 µl
AFP
TNIU
PBNP
PBNP2
PCT
* = After sample processing
0 = After dilution to obtain 15 IU/ml
1 = These tests are performed with VIDAS Stallergy.
pmol/l
nmol/l
pg/ml
pg/ml
ng/dl
ng/100 ml
pmol/l
µg/l
µg/100 ml
µg/dl
nmol/l
pg/ml
ng/l
pmol/l
ng/ml
µg/l
µg/100 ml
µg/dl
nmol/l
µg/l
ng/ml
nmol/l
µg/dl
µg/l
ng/ml
µUI/ml
µIU/ml
ng/ml 1 IRP
ng/ml 3 IS
µg/ml
UI/ml
IU/ml
mg/l
µg/l
ng/ml
µg/ml
IU/ml
UI/ml
ng/ml
µg/l
pmol/l
pg/ml
µg/l
ng/ml
Conversion
Factors
pg/ml x 3.67 pmol/l
Parameter Proposed
Code
VIDAS Unit
MYO
pmol/l x 0.272 pg/ml
pmol/l x 0.777 pg/ml
pg/ml x 1.29 pmol/l
nmol/l x 0.777 µg/l
µg/l x 1.29 nmol/l
CEAS
FSH
LH
HAVT
HCG
pmol/l x 0.651 pg/ml
pg/ml x 1.54 pmol/l
nmol/l x 0.651 µg/l
µg/l x 1.54 nmol/l
PRG
TES
IGE
nmol/l x 0.362 ng/ml
ng/ml x 2.76 nmol/l
ST
TSH
1 ng 1st IRP = 32 µ UI
1 ng 3rd IS = 21 µ UI
1 ng/ml 3rd IS =
1.524 ng/ml 1st IRP
TSH3
HBST
mg/l x 14 UI/ml
UI /ml x 0.071 mg/l
P24
CMVG
ng/ml x 0.826 UI/ml
UI /ml x 1.21 ng/ml
RBG
TXG
PC
DEX2
µg/l
ng/ml
ng/ml
mUI/ml
UI/l
mIU/ml
IU/l
mUI/ml
UI/l
mIU/ml
IU/l
kUI/l
kIU/l
mUI/ml
nmol/l
ng/ml
nmol/l
ng/ml
UI/ml
kIU/l
IU/ml
kUI/l
kIU/l
kUI/l
mUI/l
µIU/ml
mIU/l
µUI/ml
µIU/ml
µUI/ml
mIU/ml
mUI/ml
pg/ml Ag P24
pg/ml HIV Ag
AU/ml
UA/ml
UI/ml
IU/ml
IU/ml
UI/ml
UI/ml
IU/ml
%
µg/ml
ng/ml
= Default unit
FEU = Fibrinogen Equivalent Unit
Conversion
Factors
ng/ml x 15.43 mUI/ml
nmol/l x 0.3145 ng/ml
ng/ml x 3.1796 nmol/l
nmol/l x 0.288 ng/ml
ng/ml x 3.47 nmol/l
1pg/ml of P24 =
3.65 pg/ml of HIV Ag
(FEU)
(FEU)
VIDAS or mini VIDAS : Parameters
Allergy
Reproduction
Fertility
Tumor
Markers
ImmunoHemostasis
Cardiovascular
Others
Measurement
Range
or Interpretation
Code
Sample
Volume
TSH
30400
TSH
200 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep., Beads, Gel)
40
0.05 - 60 µIU/ml
TSH3
30441
TSH3
200 µl
S1 S1 S2 S2 C1 C2
14 days
no
Serum, Plasma (Hep., Silicone, Gel)
80
0.005 - 100 µIU/ml
FT4
30459
FT4N
100µl
S1 S1 C1
14 days
no
serum, plasma,(Hep.,silicon, gel)
40
1-100 pmol/ml
FT3
30402
FT3
200 µl
S1 S1 S1 C1
14 days
no
Serum, Plasma (Hep.)
40
0.7 - 45 pmol/l
T4
30404
T4
200 µl
S1 S1 S1 C1
14 days
no
Serum, Plasma (Hep.)
40
6 - 320 nmol/l
T3
30403
T3
100 µl
S1 S1 S1 C1
14 days
no
Serum, Plasma (Hep.)
40
Anti-TPO
30461
ATPO
100µl
S1 S1 C1
28 days
no
serum, plasma,(Hep. EDTA, silicon, gel)
Anti-Tg
30462
ATG
100µl
S1 S1 C1
28 days
no
Total IgE
30419
IgE
100 µl
S1 S1 C1
14 days
Stallertest
30800
STA
200 µl
S1 S1 C1 C2
Stallergy(6)
30801
ST
200 µl
Stallertroph(5)
30830
STO
HCG
30405
LH
Parameter
Test
Frequency
Sample
Pre-Treatment
Test
time
Reference*
Range
Thyroid
Calibration-Control
®
Test validated using
(minutes)
Range
Parameter
Reference* Code
Calibration-Control
Sample
Volume
Test
Frequency
Sample
Pre-Treatment
Test validated using
Measurement
Range
or Interpretation
Test
time
(minutes)
TOXO IgG II
30210
TXG
100 µl
S1 S1 C1 C2
14 days
no
Serum(3), Plasma (EDTA, Hep.)
40
TOXO IgM
30202
TXM
100 µl
S1 S1 C1 C2
14 days
no
Serum(3)
40
TOXO Competition
30211
TXC
125 µl
S1 S1 C1 C2
14 days
no
Serum, Plasma (EDTA, Hep.)
40
TOXO IgG Avidity (4)
30222
TXGA
2 x 100 µl
C1 C2
14 days
no
Serum(3), Plasma (EDTA, Hep., Cit)
40
RUB IgG II
30221
RBG
100 µl
S1 S1 C1 C2
14 days
no
Serum, Plasma (EDTA, Hep.)
40
0.4 - 9 nmol/l
RUB IgM
30214
R BM
100 µl
S1 S1 C1 C2
14 days
no
Serum
60
25
0,8-1000 IU/ml
CMV IgG
30204
CMVG
100 µl
S1 S1 C1 C2
14 days
no
Serum
40
serum, plasma,(Hep. EDTA, silicon, gel)
25
6,4-800 IU/ml
no
Serum, Plasma (Hep., EDTA)
30
0.5 - 1,000 kIU/l
CMV IgG Avidity
30203
CMVU
2 x 100 µl
CH CL
14 days
no
Serum
40
14 days
no
Serum, Plasma (Hep.)
90
Qualitative Test: Negative
Positive or Equivocal
CMV IgM
30205
CMVM
100 µl
S1 S1 C1 C2
14 days
no
Serum
60
S1 S1 C1
14 days
no
Serum, Plasma
90
0.35 - 35 kIU/l
EBV VC A IgM
30237
VC AM
100 µl
S1 S1 S1 C1 C2
28 days
no
Serum
40
200 µl
S1 S1 C1
14 days
no
Serum
90
0.35 - 35 kIU/l
EBV VC A /EA IgG
30236
VC AG
100 µl
S1 S1 S1 C1 C2
28 days
no
Serum
40
HCG
100 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep., EDTA)
30
2 - 1,500 mIU/ml
30406
LH
200 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep.)
40
0.1 - 100 mIU/ml
EBV EBNA IgG
30235
EBNA
100 µl
S1 S1 S1 C1 C2
28 days
no
Serum
40
FSH
30407
FSH
200 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep.)
40
0.1 - 110 mIU/ml
Lyme IgG and IgM
30298
LY T
100 µl
S1 S1 C1 C2
14 days
no
Serum
35
Prolactin
30410
PRL
200 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep.)
40
0.5 - 200 ng/ml
Lyme IgM
30319
LYM
100 µl
S1 S1 C1 C2
28 days
no
Serum, Plasma (Hep.)
27
Estradiol II
30431
E2II
200 µl
S1 S1 S1 C1
14 days
no
Serum, Plasma (Hep.)
60
9 - 3,000 pg/ml
Lyme IgG
30320
LYG
100 µl
S1 S1 C1 C2
28 days
no
Serum, Plasma (Hep.)
27
Progesterone
30409
PRG
200 µl
S1 S1 S1 C1
14 days
no
Serum, Plasma (Hep., EDTA, Silicone, Gel)
45
0.25 - 80 ng/ml
LYGS
100 µl
S1 S1 C1 C2
28 days
no
CSF (cerebrospinal fluid)
27
Testosterone
30418
TES
200 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep.)
60
0.1 - 13 ng/ml
Measles IgG
30219
M SG
100 µl
S1 S1 C1 C2
14 days
no
Serum
40
CEA S
30453
CEAS
200 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep.)
60
0.5 - 200 ng/ml
Mumps IgG
30218
M PG
100 µl
S1 S1 C1 C2
14 days
no
Serum
40
TPSA
30428
TPSA
200 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep., EDTA)
60
0.07 - 100 ng/ml
FPSA
30440
FPSA
200 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep., EDTA)
60
0.05 - 10 ng/ml
Varicella-Zoster IgG
30217
VZG
100 µl
S1 S1 C1 C2
14 days
no
Serum
40
AFP
30413
AFP
100 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep., EDTA), Amniotic Fluid
30
0.5 - 400 IU/ml
H. Pylori IgG
30192
HPY
100 µl
S1 S1 C1 C2
14 days
no
Serum, Plasma (EDTA)
40
CA 125 IITM
30426
125
200 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep, EDTA)
60
4 - 600 U/ml
HBs Ag Ultra (1)
30315
150 µl
S1 S1 C1 C2
14 days
no
Serum, Plasma (Hep.)
CA 19-9TM
30427
199
200 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep., EDTA)
60
3 - 500 U/ml
CA 15-3®
30429
153
100 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep. EDTA)
60
2 - 400 U/ml
Anti-HBsT Quick
HBc IgM II
30238
30439
HBS
• HBL
HBST
HBCM
150 µl
100 µl
S1 S1 C1 C2
S1 S1 C1 C2
14 days
14 days
no
no
Serum, Plasma (Hep.)
Serum, Plasma (EDTA, Hep., Cit.)
60
90
60
55
Anti-HBc Total II
30314
HBCT
150 µl
S1 S1 S1 C1 C2
14 days
no
Serum, Plasma (EDTA, Hep., Cit.)
90
D-Dimer ExclusionTM II (8)
30455
DEX2
200 µl
S1 S1 C1 C2
28 days
no
Plasma (Cit.)
20
45 - 10,000 ng/ml (FEU)
Protein C
30115
PC
100 µl
S1 S1 C1
14 days
no
Plasma (Cit.)
35
1 - 120 %
HBe Ag
30305
HBE
150 µl
S1 S1 C1 C2
14 days
no
Serum, Plasma (EDTA, Hep., Cit.)
90
CK-MB
30421
CKMB
250 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep., EDTA)
30
0 - 300 ng/ml
Anti-HBe
30305
HBET
150 µl
S2 S2 C2 C3
14 days
yes
Serum, Plasma (EDTA, Hep., Cit.)
90
Troponin I Ultra
30448
TNIU
200 µl
S1 S1 S2 S2 C1 C2
28 days
no
Serum, Plasma (Hep.)
20
0.01 - 30 µg/l
HAV IgM
30307
HAVM
100 µl
S1 S1 C1 C2
14 days
no
Serum, Plasma (EDTA, Hep.)
60
Myoglobin
30446
MYO
150 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep.)
17
5 - 1,000 µg/l
Anti-HAV Total
HIV P24 II (1)
30312
30117
HAVT
P24
150 µl
200 µl
S1 S1 C1 C2
S1 S1 C1 C2
14 days
14 days
no
no
Serum, Plasma (EDTA, Hep., Cit.)
Serum, Plasma (EDTA, Hep., Ox., Thrombin)
90
90
NT-proBNP
30449
PBNP
200 µl
S1 S1 S2 S2 C1 C2
28 days
no
Serum, Plasma (Hep.)
20
20 - 25,000 pg/ml
HIV DUO Quick
30447
HIV6
200 µl
S1 S1 C1 C2 C3
14 days
no
Serum, Plasma (EDTA, Hep.)(2)
80
NT-proBNP2
30458
PBNP2
200 µl
S1 S1 S2 S2 C1 C2
28 days
no
Serum, Plasma (Hep.)
20
20 - 25,000 pg/ml
HIV DUO Ultra
30443
HIV5
200 µl
S1 S1 S2 S2 C1 C2 C3
14 days
no
Serum, Plasma (EDTA, Hep.)(2)
120
Qualitative test: Negative, Positive
or Equivocal
Qualitative test: Negative, Positive
or Equivocal
Qualitative test: Negative, Positive
or Equivocal
Qualitative test: Negative, Positive
or Equivocal
Qualitative test: Negative, Positive
or Equivocal
Qualitative test: Negative, Positive
or Equivocal
Qualitative test:
Negative or Positive
Index, no interpretation (7)
Qualitative test: Negative, Positive
or Equivocal
Qualitative test: Negative, Positive
or Equivocal
Qualitative test: Negative, Positive
or Equivocal
Qualitative test: Negative, Positive
or Equivocal
Qualitative test:
Negative or Positive
5 - 500 mIU/ml
0 - 200 PEIU/ml
Qualitative test: Negative, Positive
or Equivocal
Qualitative test:
Negative or Positive
Qualitative test: Negative, Positive
or Equivocal
Qualitative test: Negative, Positive
or Equivocal
0 - 400 mIU/ml
0 - 400 pg/ml of Ag P24
Qualitative test:
Negative or Positive
Ag and Ab qualitative test:
Negative or Positive
Ferritin
30411
FER
100 µl
S1 S1 C1
14 days
no
Serum, Plasma (Hep., EDTA)
30
1.5 - 1,200 ng/ml
Antigen
detection
C. difficile Toxin A/B
30118
CDAB
300 µl
S1 S1 C1 C2 C3
14 days
yes(2)
Stool
75
Qualitative test: Negative, Positive
or Equivocal
Cortisol S
30451
CORS
100 µl
S1 S1 S1 C1
14 days
yes (urine)
Serum, Plasma (Hep., EDTA), 24-hour Urine
40
2 - 650 ng/ml
ß2 Microglobulin
30420
B2M
100 µl
S1 S1 C1 C2
14 days
yes (urine)
Serum, Plasma (Hep., EDTA), Urine
40
0.007 - 4 mg/l
Severe
Bacterial
Infections
BRAHMS PCT
30450
PCT
200 µl
S1 S1 S2 S2 C1 C2
28 days
no
Serum, Plasma (Hep.)(2)
20
0.05 - 200 ng/ml
Some of these reagents have not yet obtained regulatory clearance in some countries. Please contact your local bioMérieux representative for further information and product availability.
* Some references may vary according the country. Please contact your local bioMérieux representative for further information and product availability.
Serology
Hepatitis /
AIDS
(1) = Confirmation test available
(2) = See package insert
(3) = Inactivated or not 30 mins at 56°C
(4) = Double strips
(5) = Test performed with VIDAS Stallergy
(7) = Intrathecal antibody production has
(6) = Reagent strips for Stallergy tests (20 specific IgE available)
to be calculated by customer
(8) = Will progressively
replace D-Dimer
Exclusion™ (order reference 30442)
•
••
0 - 300 IU/ml
Qualitative test: Negative, Positive
or Equivocal
Qualitative test:
Negative or Positive
Avidity index (AI)
An AI ≥ 0,3 is a strong indication of a primary
infection dating back more than 4 months.
An AI < than 0,3 does not enable a recent infection
to be differentiated from a former infection.
0 - 400 IU/ml
Qualitative test: Negative, Positive
or Equivocal
0 - 400 AU/ml
Avidity index (AI)
An AI ≥ 0,8 is a strong indication of a primary infection
dating back more than 3 months.
An AI < than 0,2 is a strong indication of a primary
infection dating back less than 3 months.
An 0,2 < AI < 0,8 does not enable to distinguish
a recent infection from a former infection.
HBL = long protocol
CHB = test for confirmation of equivocal and positive CHL results
Cit. = Citrate Ox. = Oxalate Hep. = Heparin
VIDAS • PARAMETERS
®
Download
Study collections