Actim SARS-COV-2 Notice D'utilisation page 4

If, in addition to the black control line you see:
• one blue line in the lower part of the result area, the result is influenza A
positive.
• one blue line in the middle part of the result area, the result is influenza B
positive.
• two blue lines in the result area, the result is influenza A and B positive.
• no blue lines in the result area, the result is influenza A and B negative.
If the control line does not appear the test is invalid [12b].
Note! The appearance of any faint-to-dark blue test line along with a black
control line indicates a positive result.
Actim SARS-CoV-2 (dark blue dipstick)
Read the result at 15 minutes. A result can be interpreted as positive as soon
as one blue and one black line become visible in the result area. If only one
black line appears within 15 minutes, the result is interpreted as negative [13a].
Appearance of a black control line confirms that the test has been performed
properly.
If, in addition to the black control line you see:
• blue line in the result area, the result is SARS-CoV-2 positive.
• no blue line in the result area, the result is SARS-CoV-2 negative.
If the black control line does not appear, the test is invalid [13b].
Note! The appearance of any faint-to-dark blue test line along with a black
control line indicates a positive result.
Quality Control procedure
External positive controls are available separately.
Limitations of the test
• The test is intended for in vitro diagnostic use only.
• Failure to follow instructions for test procedure, using wrong specimen or
wrong interpretation of test results may affect test performance or/and
produce invalid results.
• Positive test result(s) does not rule out co-infections with other pathogens.
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EN
• A confirmed diagnosis should only be made by a physician with all clinical
data available.
Notes
• Test is for single use.
• One Swab Extraction Buffer tube contains the volume sufficient for one Actim
SARS-CoV-2 and one Actim Influenza A&B dipstick.
• No quantitative interpretation should be made based on the test results.
• Use only the swab and Swab Extraction Buffer provided with the kit.
• A negative test result may occur if the sample was collected or stored
improperly.
• The test detects both viable and non-viable SARS-CoV-2 and influenza
viruses.
• Do not use the dipstick or swab if their foil pouches or seals of the pouches
are not intact.
• Care must be taken when placing the dipstick in the sample tube. The upper
part of the dipstick must stay dry.
• Do not use a dipstick that has become wet before use, because moisture
damages the dipstick.
• Do not use a dipstick if you notice a blue or black coloring in the result area
before testing.
• If a control line does not appear, the test is invalid and should be repeated
using another dipstick.
• If the test result cannot be interpreted clearly it is recommended to perform a
new test.
• All biological specimens and materials must be treated as potentially
hazardous and disposed of in accordance with local authority guidelines.
• As with all diagnostic tests, results must be interpreted in the light of other
clinical findings.
• The performance data of Actim Influenza is obtained with the Actim Influenza
A&B test version 32836ETAC and thus contains data from all respiratory
samples. If you wish to test influenza from other than nasopharyngeal
sample, e.g. nasal swab sample, nasal aspirate and nasal wash sample,
please order the kit 32836ETAC.