Alere TestPack+Plus Strep A - Page 5

3
EN
Hazard information for the components under applicable European
Community (EC) Directives is as follows:
R25, S1/2-45-60
Toxic: Contains sodium nitrite.
R25 Toxic if swallowed.
S1/2-45-60 Keep locked up and out of the reach of children. In case of
accident, or if you feel unwell, seek medical advice immediately (show the
label where possible). This material and its container must be disposed of as
hazardous waste.
R22, S2-35-46
Harmful: Contains sodium azide
R22 Harmful if swallowed.
S2-35-46 Keep out of the reach of children. This material and its container
must be disposed of in a safe way. If swallowed, seek medical advice
immediately and show this container or label.
Safety data sheet available for professional user on request.
SPECIMEN COLLECTION & STORAGE
A specimen should be obtained by standard throat swab collection
Methods
5,6
. Use Polyester (Dacron) tipped swabs only. Do not use calcium
alginate swabs, semi-solid transport media, or media containing charcoal.
If swabs are not to be processed immediately, they can be stored in clean, dry
sealable plastic tubes refrigerated (2-8°C) for up to 72 hours before testing.
PROCEDURE
If the reagents, reaction discs and patient specimen are stored refrigerated
allow them to equilibrate to room temperature (18-30°C) for a minimum of 30
minutes before beginning the assay. Do not open foil pouches until ready to
perform the assay.
Extraction
All drops must be free falling with the reagent bottles held vertically.
1. Add 3 drops of Reagent 1 to an extraction tube. This solution must be pink.
2. Add 3 drops of Reagent 2 to the same tube. This solution must turn yellow.
3 Place the specimen swab into the tube. Twirl swab and mix well. Let stand
for a minimum of 1 minute, but no longer than 30 minutes.
4. Add 3 drops of Reagent 3 to the same tube. Twirl swab and mix well. This
solution must turn pink. Occasionally it may be necessary to add a fourth
drop of Reagent 3 to obtain colour change.
5. Thoroughly express the liquid from the swab by squeezing the tube
with the thumb and forenger, then rotating it as it is withdrawn.
6. Discard the swab safely.
7. Apply the dropper tip to the extraction tube.
The extract is stable for up to 72 hours refrigerated (2-8°C) in a covered tube.
Test Procedure
Remove the reaction disc from its foil pouch. Label with patient or control
identications. Place on a clean, at, dry surface.
8. Add the entire contents of the extraction tube drop-wise into the Sample
Well on the reaction disc.
9. Wait for a pink/red colour in the End of Assay Window to appear
(approximately 5 minutes). Read results. Do not interpret results after 10
minutes from addition of extract.
NOTE: To use Alere
TM
TestPack Strep A as a culture conrmation test,
remove an isolated beta-haemolytic colony from the culture plate with a
clean Polyester (Dacron) tipped swab and subject it to the complete test
procedure, above.
INTERPRETATION OF RESULTS
On Board Controls
Alere
TM
TestPack Strep A utilises ve On Board Controls to ensure the assay
is functioning properly.
• ThePositive On Board Control (POS CTL “√”) indicates
that both the antibody-colloid complex and capture
antibody systems are functional. The POS CTL “√” must
appear for the result to be valid.
• TheNegative On Board Control (NEG CTL “X”) indicates
that the test specimen may contain a non-specic entity
that could cause a false positive result. If the NEG CTL
“X” appears in the Result Window, the result is invalid.
• TheMinus Sign “–“ indicates that migration of the extract has occurred.
The Minus Sign “–“ must appear for the result to be valid.
• TheEnd of Assay Window must change to a red/pink colour, which
indicates that the test is complete and ready to read. The End of Assay
colour change must occur for the result to be valid. Do not interpret
results after 10 minutes from addition of extract.
Minus Sign
Patient Bar
• The Extraction Reagent Control is demonstrated by colour changes during
the swab extraction process to indicate that Reagents 1, 2 and 3 are added
in the correct order. Reagent 1 is pink, but will change to yellow when
Reagent 2 is added. After adding Reagent 3 the solution changes back
from yellow to pink. If either of the colour changes does not occur, the test
is invalid.
TP Strep A ROW 240599R4_5.indd 3 2011/08/12 12:00:18