Reagent Preparation; Storage Conditions And Stability Of Reagents; Procedural Precautions; Assay Procedure - Axis-Shield RPR Bedienungsanleitung

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Reagent preparation

Prepare the following reagent before starting the assay procedure. Reagents and samples should be
equilibrated to room temperature (15 to 30 °C) before beginning the assay and can remain at room
temperature during testing. Store reagents at 2 to 8 °C when not in use.
The Antigen suspension is ready to use. Ensure that the suspension is allowed to reach room
temperature and is shaken well before use. Remove the cap from the plastic dispensing bottle and
attach a dispensing needle via the luerlock plug. Then transfer the Antigen Suspension to the
dispensing bottle by squeezing the plastic dispensing bottle and inserting the tip of the needle into the
Antigen suspension. Allow the plastic bottle to expand. This will then suck up the Antigen suspension.
After each day of testing return any unused Antigen suspension into the original glass vial.
Rinse the plastic bottle and needle with distilled water and air dry.
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Storage conditions and stability of reagents

The kit is stable until the date given on the pack when stored between 2 and 8 °C.
Do not freeze the Antigen Suspension.
Do not store the Antigen Suspension in the plastic dispensing bottle, as this will reduce the shelf life of
the product.
After opening the test pack, store the test cards at ambient temperature. Do not place in the
refrigerator.
Store unopened components at 2 to 8° C.
Note: Components, either unopened or opened, may not be used after the expiry date printed on the
label of each component.
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Procedural precautions

Check all packaging before using the kit. Damage to the outer packaging does not prevent the
contents of the kit from being used. However, if the packaging is damaged the user must check that
components of the kit are intact before using them.
Do not exchange assay specific components carrying the G2 assay code between kits having different
packing numbers.
Alterations in the physical appearance of assay kit materials may indicate instability or deterioration.
All reagents must be mixed well before use.
Avoid microbial or any other contamination of reagents.
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Assay procedure

1 Use a new pipette for each sample. It is important to maintain the pipette in a vertical position to
ensure an accurate drop is dispensed.
2 With an assembled pipette and suction cap, take up sufficient sample and transfer one free-falling
drop onto a circle on the test card.
3 Using a spatula spread the sample over the entire area of the test circle.
4 Ensure that the Antigen Suspension is homogeneous by gently shaking the plastic dispensing
bottle (+ needle) containing the Antigen Solution.
5 Hold the bottle in a vertical position and dispense one free-falling drop to the same test circle. Do
not stir!
6 Immediately place the card on a platform mixer and rotate the card at 100 rpm.
7 Read results after 8 minutes.
To perform a semi-quantitative test, prepare a serial dilution of the sample in physiological saline and
test each dilution as described for the qualitative test.
Antigen suspension
Qualitative test
Semi-quantitative test
Quality Control (optional)
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