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Test Result
After automatic processing of the sample with the Vivalytic one analyser the
test result is shown on the screen of the Vivalytic one analyser. Time-to-re-
sult is about one hour.
The sample is classified either as valid positive (if at least one of the targets
M. genitalium, M. hominis, or U. parvum/urealyticum is detected), valid neg-
ative (if no target and only Human Control is detected) or invalid (if neither
target nor Human Control is detected). In case of a positive detection of one
or more targets, the test is considered valid even if the Human Control is
negative.
U. parvum and U. urealyticum are both detected in one channel. A positive
result for UP/UU indicates the presence of either one or both species.
Detection of the human cell based whole process control (Human Control)
shows a successful DNA purification and amplification procedure and
excludes an inhibition of the PCR reaction.
Interpretation of results is shown in the table below.
Interpretation of Results
M. genitalium
M. hominis
+
–
+
+
+
–
–
–
–
Retesting is recommended.
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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 considered invalid if neither target(s) nor Human Control is detected.
Possible reasons for an invalid run might be poor sample quality due to a par-
tial or complete absence of human cellular material in the sample. Results
are displayed for an invalid test but are not allowed to be used for diagnostic
interpretation.
Vivalytic MG, MH, UP/UU
U. parvum/
urealyticum
+
+
+
+
–
+
+
–
–
–
+
–
–
+
–
–
–
–
Value
q
– Instructions for Use
Human
Validity
Result
Control
Sample is considered positive
+/–
valid
for M. genitalium, M. hominis
and U. parvum/urealyticum
Sample is considered positive
+/–
valid
for M. hominis and U. parvum/
urealyticum
Sample is considered positive
+/–
valid
for M. genitalium and
U. parvum/urealyticum
Sample is considered
+/–
valid
positive for M. genitalium and
M. hominis
Sample is considered positive
+/–
invalid
for M. genitalium
Sample is considered positive
+/–
valid
for M. hominis
Sample is considered positive
+/–
valid
for U. parvum/urealyticum
Sample is considered negative
+
valid
for M. genitalium, M. hominis
and U. parvum/urealyticum
–
invalid
Not evaluable.
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