PEBBLE qcLAMP Platform
39 |
I N S T R U C T I O N S F O R U S E
v1.1 10.08.2021
Please make sure that the data
are visible only by the authorized
user and the patient that the
analysis refers to.
10.
RESULTS INTERPRETATION
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Color change is expressed as color index units on the Y-axis of a real-time curve that is displayed
on the screen of a smart device. Up to six (6) curves can be displayed simultaneously.
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The duration of a test is 30 min. Evaluation of the results should be performed by the end-user.
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POSITIVE TEST RESULTS
o
The specific time-point at which a change in the slope of the real-time curve occurs (color
index units increase) corresponds to the “time
-to-
positive” result (red solid line). This is the
point at which the two dotted red lines cross each other (Figure 10.1).
o
When a sample is positive for any target, the slope of the curve will change (Figure 10.1).
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NEGATIVE TEST RESULTS
o
A negative result is indicated by a flat curve (color index units do not increase) maintained
throughout the monitoring period.
-15
-10
-5
0
5
10
15
20
0
5
10
15
20
25
30
Col
or
Inde
x
U
ni
ts
(pi
xel
s)
Time (min)
Positive sample (example)
Figure 10.1: Time-to-positive interpretation results when a sample is positive.