Instruction Manual
Table Of Contents
- Intended Use
- Summary and Explanation
- Principles of the Procedure
- Materials Required (Provided)
- DTT solution 500mM
- SARS-CoV-2 PCR Mix
- Equipment and Supplies
- Warnings and Precautions
- Specimen Collection, Handling, and Storage
- Procedure
- For viscous samples (sputum and bronchial wash): Performed inside BSC 2
- NOTE: In the event that the test system becomes inoperable, notify supervision or designee for further direction. Patient specimens must be stored in a manner that maintains the integrity of the specimen.
- Quality Control
- Limitations
- Conditions of Authorization for the Laboratory
- Performance Characteristics
- References
9
SPECIMEN TRANSFER PROCEDURE for the Omega Method using the HAMILTON STAR
(to be performed in Extraction Room)
1. Total nucleic acids (DNA and RNA) are extracted from patient specimens and assay controls using the
Mag-Bind Viral RNA Xpress Kit (Omega Bio-Tek) on the Hamilton MagEx STAR Autoload automated
platform.
Refer to PROC.129.01744- Hamilton MagEx STAR Autoload System Use and Maintenance for general
instructions on using the Hamilton STAR.
2. Decontaminate work area by wiping down work surface and pipettes with 10% bleach. Let soak for 1
minute. Wipe down work surface and pipettes with 70% ethanol and dry with paper towels.
3. Remove one aliquot of NCOV Positive Control and NCOV Negative Control from the freezer and let
thaw at room temperature. Vortex and spin down.
4. Create Hamilton and AB7500 setup maps for the samples to be tested. For example: 94 patient
specimens can be run in a single set-up, along with 2 controls (1 Positive Control, 1 Negative, and 94
patient specimens per 96 wells).
1
2
3
4
5
6
7
8
9
10
11
12
A
Pos
8
16
24
32
40
48
56
64
72
80
88
B
1
9
17
25
33
41
49
57
65
73
81
89
C
2
10
18
26
34
42
50
58
66
74
82
90
D
3
11
19
27
35
43
51
59
67
75
83
91
E
4
12
20
28
36
44
52
60
68
76
84
92
F
5
13
21
29
37
45
53
61
69
77
85
93
G
6
14
22
30
38
46
54
62
70
78
86
94
H
7
15
23
31
39
47
55
63
71
79
87
Neg
Rotating positional control based on the load number will be used for specific identification of the
extraction plate and prevention of plate switch. Refer to additional preventive measures on
PROC.129.01038 and PROC.129.01611
5. For controls and upper respiratory patient specimens, pipette 240 uL Hamilton Lysis Buffer followed
by 200 uL of specimen into the appropriate well of a Hamilton deep well plate.
Note: The Hamilton is not for use with Sputum or BAL specimens.
6.
Visually check the level of samples and controls in the deep well plate to ensure sample was added to
the appropriate wells.
7.
Cover the deep well plate with an absorbent wipe and put into a clean biohazard bag then seal before
transporting to the Hamilton STAR.
8
Label the load name on the extraction and output to each corresponding plate that will be loaded on the
HamiltonCheck the position of the corresponding plates on the Hamilton deck.