Sample Requirements for Infectious Disease Testing

Sample Requirements for Infectious Disease Testing
SEROLOGY: CADAVERIC AND POST-MORTEM DONORS
SERUM
TEST
HBsAg
Bio-Rad
HIV I/II Plus O Ab
EIAs
Bio-Rad
Hep B Core Total Ab
Ortho
HCV Ab
Ortho
LABS
TEST
CODE
PLASMA
FDA CADAVERIC
Red Top, SST,
Gold, or Tiger Top
EDTA
Lavender/Pink Top
Heparin
Green Top
ACD
Yellow Top
Sodium Citrate
Blue Top
YES
YES
NO
NO
NO
NO
3211
NO
YES
YES
YES
YES
YES
3221
YES
YES
YES
NO
NO
NO
7 Days: ≤ 37°C
3214
3521
14 Days : ≤ 30°C
NO
YES
YES
YES
NO
YES
Over 14 Days:
≤ -20°C
NO
NO
NO
NO
NO
NO
Not Suitable for
Testing
3217
NO
NO
NO
NO
NO
NO
Not Suitable for
Testing
3220
NO
NO
NO
NO
NO
NO
Not Suitable for
Testing
3223
YES
NO
NO
NO
NO
3542
NO
YES
NO
YES
YES
3224
YES
NO
NO
NO
NO
3546
(LABS-CO)
HBsAg /
HBsAg Confirmatory
Abbott PRISM
(LABS-CO)
3218
3219
Hep B Core Total Ab
Abbott PRISM
(LABS-CO)
HIV I/II Plus O
PRISM
Abbott PRISM
(LABS-CO)
HCV Ab
Abbott PRISM
(LABS-CO)
HTLV I/II Ab
Abbott PRISM
YES
Filtered Only
YES
48 Hours: 2-8°C
(LABS-CO)
T. cruzi (Chagas) Ag
Abbott PRISM
(LABS-CO)
LABS, Inc.
Over 7 Days:
≤ -20°C
6 Days: ≤ 37°C
7 Days: 2-8°C
Over 7 Days:
≤ -20°C
7 Days: ≤ 37°C
10 Days: 2-8°C
28 Days: ≤ -20°C
HTLV I/II Ab
Avioq
Outdate
YES
Filtered Only
Over 48 Hours:
≤ -20°C
7 Days: ≤ 30°C
14 Days: 2-8°C
Over 14 Days:
≤ -20°C
48 Hours: ≤ 30°C
Page 1 of 8
14 Days:
2-8°C / ≤ -20°C
VID-JBA-024 Revision 3
Sample Requirements for Infectious Disease Testing
SEROLOGY: CADAVERIC AND POST-MORTEM DONORS
SERUM
TEST
ABO/Rh
Manual
LABS
TEST
CODE
FDA CADAVERIC
14
NO
Red Top
EDTA
Lavender Top
Heparin
Green Top
YES
21 Days
YES
10 Days
Up to Tube Exp.
YES
No Separator
Tubes
No Separator
Tubes
No Separator
Tubes
Up to Tube Exp.
Blood Typing
ABO/Rh
Immucor NEO
(LABS-CO)
14
NO
NO
WEAK D
Immucor NEO
(LABS-CO)
A1 Subtyping
Manual
Hemoglobin S
NEO/Manual (LABS-CO)
Manual (LABS-NE)
TPHA Screen
Immucor NEO
(LABS-CO)
RPR
RPR Titer
Arlington Scientific, Inc.
No Separator
Tubes
YES
14 Days
NO
NO
YES
YES
94
NO
No Separator
Tubes
No Separator
Tubes
1807
NO
71
NO
CMV Ab
Immucor
YES
10 Days
14
RBC Ab Screen
Immucor NEO
(LABS-CO)
PLASMA
3503
3549
NO
NO
WNV IgG
WNV IgM
108
Focus
(LABS-CO)
109
NO
NO
YES
Up to Tube Exp.
YES
35 Days
NO
YES
NO
YES
YES
YES
14 Days
2 Days
NO
NO
NO
YES
YES
No Separator
Tubes
No Separator Tubes
NO
NO
NO
NO
NO
YES
YES
YES
NO
Not Suitable for Testing
YES
LABS, Inc.
49
< 48 Hours Old and
Do Not Freeze
< 48 Hours Old and
Do Not Freeze
NO
YES
NO
NO
NO
NO
NO
NO
YES
NO
NO
NO
Page 2 of 8
Over 7 Days:
Serum:
5 Days from Collection
Over 5 Days: ≤ -20°C
NO
HbA1c
Bio-Rad D-10
(LABS-CO)
5 Days: ≤ 25°C
7 Days: 1-10°C
Over 7 Days:
≤ -20°C
7 Days: 1-10°C
≤ -20°C
YES
< 48 Hours Old and
Do Not Freeze
Test as soon as possible after
collection (can be frozen if
separated from cells)
See specific sample type
for outdate at
2-8°C
NO
NO
STORE AT 1-10°C AS
SOON AS POSSIBLE
14 Days
NO
YES
STORE AT 1-10°C AS
SOON AS POSSIBLE
SEE SAMPLE TYPE FOR
OUTDATE AT 1-30°C
NO
No Separator
Tubes
STORE AT 1-10°C AS
SOON AS POSSIBLE
SEE SAMPLE TYPE FOR
OUTDATE AT 1-30°C
YES
YES
Outdate
SEE SAMPLE TYPE FOR
OUTDATE AT 1-30°C
NO
No Separator
Tubes
3550
Sodium Citrate
Blue Top
YES
14 Days
3551
NO
No Separator
Tubes
ACD
Yellow Top
Plasma:
2 Days from Collection
8 Hours: ≤ 22°C
48 Hours: 2-8°C
Over 48 Hours:
≤ -20°C
3 Days: RT
7 Days: 2-8°C
Do Not Freeze
VID-JBA-024 Revision 3
Sample Requirements for Infectious Disease Testing
SEROLOGY: CADAVERIC AND POST-MORTEM DONORS
SERUM
TEST
FTA-ABS
Scimedx
LABS
TEST
CODE
FDA CADAVERIC
Red Top, SST,
Gold, or Tiger Top
EDTA
Lavender Top
Heparin
Green Top
ACD
Yellow Top
Sodium Citrate
Blue Top
3552
NO
YES
NO
NO
NO
NO
3522
NO
YES
YES
YES
YES
YES
3215
YES
YES
NO
NO
NO
NO
3213
NO
YES
YES
YES
NO
YES
3212
NO
YES
YES
YES
YES
YES
Confirmatories
Hep B Core IgM
Bio-Rad
(LABS-CO)
Over 7 Days:
≤ -20°C
8 Hours: RT
7 Days: 2-8°C
Over 7 Days:
≤ -20°C
8 Hours: ≤ 22°C
48 Hours: 2-8°C
Over 48 Hours:
≤ -20°C
IFAs /
Viral Slides
7 Days: ≤ 30°C
EBV IgG, EBV IgM,
HSV IgG, HSV IgM
3511, 3512,
3531, 3532
NO
YES
NO
NO
NO
NO
Meridian
8 Hours: ≤ 22°C
48 Hours: 2-8°C
nPOD
CMV IgG Ab, CMV IgM Ab
Bio-Rad
CMV (LABS-CO ONLY)
3504, 3505
NO
YES
(LABS-CO ONLY)
NO
NO
NO
NO
Over 48 Hours:
≤ -20°C
GADA, IA-2, & ZnT8
Autoantibody EIA
KRONUS
3545
NO
YES
NO
Research Use Only
LABS, Inc.
STORE AT 2-8°C AS SOON
AS POSSIBLE
Over 7 Days:
≤ -20°C
(LABS-CO)
Viral EIAs
Over 7 Days:
≤ -20°C
7 Days: ≤ 37°C
Hep B Surface Ab
Bio-Rad
(LABS-CO)
Over 7 Days:
≤ -20°C
7 Days: ≤ 37°C
HBsAg Confirmatory
(Neutralization)
Bio-Rad
Outdate
7 Days: ≤ 37°C
HIV-1 WB
Bio-Rad
(LABS-CO)
PLASMA
Page 3 of 8
NO
NO
NO
Test as soon as
possible or freeze at
≤ -20°C
VID-JBA-024 Revision 3
Sample Requirements for Infectious Disease Testing
SEROLOGY: LIVING AND PRE-MORTEM DONORS
SERUM
TEST
HBsAg
Bio-Rad
HIV I/II Plus O Ab
Bio-Rad
EIAs
Hep B Core Total Ab
Ortho
HCV Ab
Ortho
LABS
TEST
CODE
Red Top, SST,
Gold, or Tiger Top
EDTA
Lavender Top
Heparin
Green Top
ACD
Yellow Top
Sodium Citrate
Blue Top
YES
YES
YES
YES
YES
3211
YES
YES
YES
YES
YES
3221
YES
YES
YES
YES
YES
3546
YES
YES
YES
NO
YES
YES
YES
NO
YES
YES
3217
YES
YES
NO
YES
YES
3223
YES
YES
NO
YES
YES
3220
YES
YES
NO
YES
YES
3542
YES
YES
NO
YES
YES
3224
YES
YES
NO
YES
YES
3521
Abbott PRISM
(LABS-CO)
3218
3219
Hep B Core Total Ab
Abbott PRISM
PRISM
(LABS-CO)
HCV Ab
Abbott PRISM
(LABS-CO)
HIV 1 & 2 Plus O
Abbott PRISM
(LABS-CO)
HTLV I/II Ab
Abbott PRISM
(LABS-CO)
(LABS-CO)
LABS, Inc.
28 Days: ≤ -20°C
Over 14 Days:
≤ -20°C
7 DAYS: ≤ 30°C
14 DAYS: 2-8°C
Over 14 Days:
≤ -20°C
7 Days: ≤ 30°C
14 Days: 2-8°C
Over 14 Days:
≤ -20°C
7 Days: ≤ 30°C
14 Days: 2-8°C
Over 14 Days:
≤ -20°C
7 Days: ≤ 30°C
14 Days: 2-8°C
6 Months:
≤ -20°C
7 Days: ≤ 30°C
14 Days: 2-8°C
Over 14 Days:
≤ -20°C
7 Days: ≤ 30°C
T. cruzi (Chagas) Ag
Abbott PRISM
Over 7 Days:
≤ -20°C
6 Days: ≤ 37°C
7 Days: 2-8°C
Over 7 Days:
≤ -20°C
7 Days: ≤ 37°C
10 Days: 2-8°C
14 Days: ≤ 30°C
(LABS-CO)
HBsAg
HBsAg Confirmatory
Outdate
7 Days: ≤ 37°C
3214
HTLV I/II Ab
Avioq
PLASMA
Page 4 of 8
14 Days:
2-8°C / ≤ -20°C
VID-JBA-024 Revision 3
Sample Requirements for Infectious Disease Testing
SEROLOGY: LIVING AND PRE-MORTEM DONORS
SERUM
TEST
ABO/Rh
Blood Typing
Manual
LABS
TEST
CODE
14
ABO/Rh
Immucor NEO
14
PLASMA
Red Top
EDTA
Lavender Top
Heparin
Green Top
YES
21 Days
YES
10 Days
Up to Tube Exp.
YES
No Separator
Tubes
No Separator
Tubes
No Separator
Tubes
Up to Tube Exp.
NO
YES
10 Days
(LABS-CO)
No Separator
Tubes
WEAK D
YES
14 Days
Immucor NEO
14
NO
YES
YES
94
No Separator
Tubes
No Separator
Tubes
(LABS-CO)
RBC Ab Screen
Immucor NEO
(LABS-CO)
A1 Subtyping
Manual
Hemoglobin S
1807
71
CMV Ab
Immucor
NEO/Manual (LABS-CO)
Manual (LABS-NE)
3503
TPHA Screen
Immucor NEO
3549
(LABS-CO)
RPR
RPR Titer
Arlington Scientific, Inc.
Focus
109
49
YES
Up to Tube Exp.
YES
35 Days
NO
YES
NO
YES
YES
14 Days
2 Days
NO
YES
YES
YES
YES
No Separator
Tubes
No Separator Tubes
YES
YES
No Separator
Tubes
No Separator
Tubes
NO
YES
YES
YES
Outdate
SEE SAMPLE TYPE FOR
OUTDATE AT 1-30°C
NO
STORE AT 1-10°C AS
SOON AS POSSIBLE
SEE SAMPLE TYPE FOR
OUTDATE AT 1-30°C
NO
NO
NO
STORE AT 1-10°C AS
SOON AS POSSIBLE
SEE SAMPLE TYPE FOR
OUTDATE AT 1-30°C
STORE AT 1-10°C AS
SOON AS POSSIBLE
Test as soon as possible after
collection (can be frozen if
separated from cells)
14 Days
See specific sample type
for outdate at
2-8°C
YES
45 Days: 1-10°C
YES
5 Days: ≤ 25°C
NO
YES
NO
7 Days: 1-10°C
Over 7 Days:
≤ -20°C
7 Days: 1-10°C
NO
NO
Over 7 Days:
≤ -20°C
Serum:
YES
NO
< 48 Hours Old and < 48 Hours Old
Do Not Freeze
and Do Not Freeze
< 48 Hours Old
and Do Not Freeze
5 Days from Collection
Over 5 Days:
20°C
Plasma:
≤-
2 Days from Collection
8 Hours: ≤ 22°C
YES
HbA1c
NO
NO
NO
NO
48 Hours: 2-8°C
Over 48 Hours:
≤ -20°C
3 Days: RT
NO
YES
(LABS-CO)
LABS, Inc.
NO
YES
108
Bio-Rad D-10
NO
YES
3550
Sodium Citrate
Blue Top
YES
14 Days
3551
WNV IgG
WNV IgM
(LABS-CO)
No Separator
Tubes
ACD
Yellow Top
Page 5 of 8
NO
NO
NO
7 Days: 2-8°C
Do Not Freeze
VID-JBA-024 Revision 3
Sample Requirements for Infectious Disease Testing
SEROLOGY: LIVING AND PRE-MORTEM DONORS
SERUM
TEST
FTA-ABS
Scimedx
LABS
TEST
CODE
Red Top
EDTA
Lavender Top
Heparin
Green Top
ACD
Yellow Top
Sodium Citrate
Blue Top
3552
YES
NO
NO
NO
NO
3522
YES
YES
YES
YES
YES
3215
YES
YES
YES
YES
YES
3213
YES
YES
YES
NO
YES
3212
YES
YES
YES
YES
YES
Confirmatories
Hep B Core IgM
nPOD
Viral EIAs
IFAs /
Viral Slides
Bio-Rad
(LABS-CO)
LABS, Inc.
Over 7 Days:
≤ -20°C
7 Days: ≤ 37°C
Hep B Surface Ab
Bio-Rad
(LABS-CO)
Over 7 Days:
≤ -20°C
7 Days: ≤ 37°C
HBsAg Confirmatory
(Neutralization)
Bio-Rad
Outdate
7 Days: ≤ 37°C
HIV-1 WB
Bio-Rad
(LABS-CO)
PLASMA
Over 7 Days:
≤ -20°C
8 Hours: RT
7 Days: 2-8°C
Over 7 Days:
≤ -20°C
8 Hours: ≤ 22°C
48 Hours: 2-8°C
Over 48 Hours:
≤ -20°C
7 Days: ≤ 30°C
EBV IgG, EBV IgM,
HSV IgG, HSV IgM
3511, 3512,
3531, 3532
YES
NO
NO
NO
NO
Meridian
Over 7 Days:
≤ -20°C
(LABS-CO)
CMV IgG Ab, CMV IgM Ab,
EBV IgG Ab, EBV IgM Ab,
Toxo IgG
Bio-Rad
EBV and Toxo (LABS-NE ONLY)
STORE AT 2-8°C AS SOON
AS POSSIBLE
3504, 3505,
3513, 3514,
3535
YES
NO
NO
NO
NO
8 Hours: ≤ 22°C
48 Hours: 2-8°C
Over 48 Hours:
≤ -20°C
3545
YES
NO
NO
NO
NO
Test as soon as
possible or freeze at
≤ -20°C
CMV (LABS-NE and LABS-CO)
GADA, IA-2, & ZnT8
Autoantibody EIA
KRONUS
Research Use Only
Page 6 of 8
VID-JBA-024 Revision 3
Sample Requirements for Infectious Disease Testing
NAT: LIVING & PRE-MORTEM DONORS
SERUM
LABS
TEST
PLASMA
Red Top, SST,
Gold, or Tiger
Top
TEST
CODE
EDTA
Lavender Top
Heparin
Green Top
ACD
Yellow Top
Sodium Citrate
Blue Top
Storage Outdate
Plasma:
24 HOURS: 25-30°C *
9235
NO
72 HOURS: ≤ 25°C
YES
WNV NAT
YES
(Do Not Pool)
Novartis
Tigris
9229
(Pool)1
Ultrio &
Discriminatory
YES
(Do Not Pool)
1
Only Living
EDTA samples
may be pooled
NO
8 DAYS TOTAL:
IF CENTRIFUGED
WITHIN 72 HOURS
9 MONTHS: ≤ -20°C
15 MONTHS: ≤ -70°C
3770 (Ultrio)
Serum:
Plasma:
2099 (Pool)1
24 HOURS: *
24 HOURS: *
3771 (HIV)
HIV/HCV/HBV NAT
Novartis
Tigris
YES
(Do Not Pool)
3772 (HCV)
YES
YES
(Do Not Pool)
YES
(Do Not Pool)
3773 (HBV)
1
3775 (Discrim)
Only Living EDTA
samples may be
pooled
YES
(Do Not Pool)
YES
(Do Not Pool)
25-30°C
25-30°C
72 HOURS:
72 HOURS:
≤ 25°C
≤ 25°C
8 DAYS TOTAL:
8 DAYS TOTAL:
IF CENTRIFUGED
WITHIN 72 HOURS
IF CENTRIFUGED WITHIN
72 HOURS
Frozen not
observed.
6 MONTHS:
≤ -20°C
* The 24 hours up to 30°C may occur at any time during storage. Do not exceed 24 hours total exposure to these temperatures
TEMP
LABS, Inc.
25-30°C
8-25°C
2-8°C
DAYS
1
2
3
4
5
6
7
Graph is not linear - the temp and day
combination cannot be exceeded
8
Page 7 of 8
VID-JBA-024 Revision 3
Sample Requirements for Infectious Disease Testing
NAT: CADAVERIC AND POST-MORTEM DONORS
SERUM
LABS
TEST
TEST
FDA
CADAVERIC
CODE
Red Top, SST,
Gold, or Tiger
Top
EDTA
Lavender Top
Heparin
Green Top
ACD
Yellow Top
Sodium Citrate
Blue Top
YES
9235
WNV NAT
PLASMA
Novartis
Tigris
YES
YES
NO
NO
NO
NO
3770 (Ultrio)
2099 (Pool)1
Ultrio &
Discriminatory
3771 (HIV)
HIV/HCV/HBV NAT
Novartis
Tigris
3772 (HCV)
3773 (HBV)
3775 (Discrim)
TEMP
LABS, Inc.
8-25°C
2-8°C
DAYS
8-25°C
2-8°C
DAYS
Serum:
24 HOURS: *
≤ 25°C
Plasma:
24 HOURS: *
≤ 25°C
72 HOURS TOTAL:
72 HOURS:
2-8°C
2-8°C
8 DAYS TOTAL:
9229
(Pool)1
TEMP
Storage Outdate
YES
YES
YES
NO
NO
1
Cadaveric NAT
samples may not
be pooled
2
3
4
2
3
4
Serum:
24 HOURS: *
≤ 25°C
11 DAYS:
≤ -70°C
Plasma:
24 HOURS: *
≤ 25°C
72 HOURS:
72 HOURS:
2-8°C
5 DAYS TOTAL:
2-8°C
8 DAYS TOTAL:
IF CENTRIFUGED
WITHIN 72 HOURS
IF CENTRIFUGED WITHIN
72 HOURS
14 DAYS FROM
COLLECTION:
≤ -70°C
* The 24 hours up to 25°C may occur at any time
during storage. Do not exceed 24 hours total
exposure to these temperatures
5
Plasma Sample Graph
1
IF CENTRIFUGED WITHIN
72 HOURS
14 DAYS FROM
COLLECTION:
≤ -70°C
Serum Sample Graph
1
NO
11 DAYS:
≤ -70°C
5
7
Graphs are not linear - the temp and day
combination cannot be exceeded
8
Page 8 of 8
VID-JBA-024 Revision 3