Publicité
Vivalytic Bordetella
IS481
hIS1001 pIS1001
5
+
–
+
+
–
–
+
–
+
+
–
+
–
+
–
–
–
–
In the case of a positive signal for B. holmesii, a mixed sample with B. pertussis cannot
1
be excluded as the two species share identical sequences within the amplified region
of IS481.
B. parapertussis positive (!)
2
Samples close to LOD might not show a positive signal for all defined targets and are
therefore classified as negative for B. pertussis and B. holmesii. That does not exclude
an infection with these pathogens. Retesting is advised.
Negative (!)
3
Samples close to LOD might not show a positive signal for all defined targets and are
therefore classified as negative for B. pertussis, B. parapertussis and B. holmesii. That
does not exclude an infection with these pathogens. The result must not be used.
Retesting is advised.
Retesting is recommended.
4
The IS481 and pIS1001 insertional elements can also be present in B. bronchiseptica.
5
PCR – Curve and C
Real-time PCR curves (software-modified) are shown and classified as
positive or negative by the software. In case of positive curves, the respective
C
value is displayed. Inconclusive results are marked by the software ().
q
Retesting is advised.
Invalid or Failed Tests
A test is rated as invalid if neither target DNA nor Human Control is detected.
Possible reasons for an invalid run might be poor sample quality due to a
partial or complete absence of human cellular material in the sample. Pay at-
tention to use the correct sample type, sample collection and storage of the
sample and cartridges prior to the test run. If required, repeat the analysis
with a new sample.
In case of a failed test, first check for correct operating conditions of the
Vivalytic one analyser (refer to Vivalytic one analyser's Instructions for Use).
Restart the Vivalytic one analyser. If the problem persists, contact the cus-
tomer support of your local distributor.
– Instructions for Use
Human
Result
5
Control
–
+/–
Sample is considered positive for B. pertussis.
–
+/–
Sample is considered positive for B. holmesii.
+
+/–
Sample is considered positive for B. parapertussis.
Sample is considered positive for B. pertussis and
+
+/–
B. parapertussis.
Sample is considered positive for B. parapertussis and
+
+/–
B. holmesii.
+
+/–
Sample is considered positive for B. parapertussis (!).
–
+/–
Sample is considered negative (!).
–
+
Sample is considered negative.
–
–
Invalid.
Value
q
1
4
5
1
2
3
Publicité
