FAQ: Methodology/performance

When dipping  the stick in diluted sample, the level of sample passes beyond the limit indicated by the arrows at the back of the stick. Is there any consequences on the test reactivity?

The red arrow indicates the limit that could not be passed beyond during any incubation.
Depending on the assay tube used routinely in laboratories, it could happen that the limit line indicated on the sticker could be overcome. It cannot give rise to any problems on the result itself, provided the limit indicated by the red arrow on the figure is not passed. The gold conjugate is placed at 2cm from the bottom of the stick. Incubation limit should not exceed 1cm, i.e. the green line indicated on the figure.

 

What happens when faecal specimen is not diluted enough in the Dilution Buffer? What about the control line?

In the IFUs (Point VII. Procedure) Coris BioConcept underlines that after adding 15 drops into a test tube you must "Plunge the inoculating loop containing the stool sample into the tube. The dilution ratio must be at most 4% w/v, which equals the contents of 10µl Loops".
Once you have stirred to homogenize you just have to wait 1 to 2 minutes before testing.
With that sentence we try to avoid problems when stool specimen is highly positive and not diluted enough in the Dilution Buffer. When the conjugate-virus complex reaches the Test Line(s) - Lower Line(s) - it remains bound to the antibody coated on the nitrocellulose.
Nevertheless, when a strong positive is to be detected, almost all conjugates are bound to viruses and remain on the specific antibody (lower line) coated onto the nitrocellulose, giving rise to a strong dark-red signal. As a consequence, quantity of remaining gold conjugate that should come to react with the control reagent (upper line) is not enough to give rise to a visible signal. Thus control line appears too weak or even sometimes is not visible by eyes.

 

Why does the control line sometimes appear very weak while the test line is positive?

Control line is aimed to ensure that chromatography has been performed up to the top of the strip. It is not related with the result of the diagnostic itself.

Control line may sometimes be "very weak" when the sample is highly positive.
Signal on the control line comes from the remaining conjugate that didn't react with the antigen on the specific live.
More positive will be the specific signal, less positive will be the signal on the control line.

The control line confirms that migration proceeded successfully even if the line is only slightly rose or dark red.

 

Cuando se introduce una varilla en la muestra diluida, el nivel de la dilución sobrepasa el límite indicado por las flechitas que se encuentran en la parte trasera de la varilla. Puede plantear problema?

Cuando se sumerge una varilla dentro del tampón de dilución para llevar a cabo un test, hay que prestar atención en NO sobrepasar la línea horizontal que se encuentra debajo de las flechitas rojas.
En algunos casos, todo depende de la talla del tubo de ensayo utilizado, puede ocurrir que el límite de esta ínea horizontal sea sobrepasado. No plantea ningún problema para la lectura de los resultados mientras el tampón de dilución no llega a la gran flecha roja del dibujo (es decir debajo del conjugado de particulas de oro). Este conjugado se encuentra colocado a 2 centimetros del borde inferior de la varilla. Hay que tener cuidado en no sumergir la varilla más alla de 1 centimetro, como lo indica la gran flecha verde del dibujo.

 

Stability relatively short after opening

Indeed the product is stable during at least 15 weeks after first opening. 15 weeks is quite high : that means less than 2 tests per week. Stability is dependant of the storage conditions.
Immunochromatographic test uses nitrocellulosic support which is sensitive to humidity.
That's why we put dessicant in the tube and in the cap.
If the storage is done under dry condition, stability is higher than 15 weeks.
In each case, there is an internal control (upper line). If this internal control appears during the run, that means that the test is running well. We have to give a shelf life, but the test can be used after 15 or 20 weeks. The result will be always valid, but only if the control line appears.

 

Why the kit doesn't contain loop and tube?

The kit doesn't contain the loop and the plastic tube because that material is very common in all labs. In general the labs obtain good price on the plastic disposable.
We want to offer the most competitive price which means that if we had to furnish this material, we would have to take a little margin on it and price of shipment would be higher.
On the economical point of view it is more interesting for the customer to buy loops and tubes himself.
With the dropper bottle, he doesn't have to use any micropipettes. He just needs one inoculating loops and one 3 or 5 ml test tube.

 

How to use correctly Coris BioConcept's kits?

- Always store the test between 4 and 37 degree Celsius
- Always use gloves to touch the strips
- Always use the Extraction/Dilution Buffer even if the sample is already diluted (in a transport medium for instance)
- Always be sure that the solution is homogenous before testing
- Always be sure that the solution does not touch directly the gold conjugate (red zone on the strip)
- Always read the results when the stick is wet (between 10 and 15 minutes)
- After opening of the tube containing the strips, quality is guaranteed during 15 weeks (12 months if not opened)
- Always close the tube after each use to avoid that strips become wet. Take care to leave the desiccant inside the tube

 

Does the faeces test also detect the types of Adenovirus that can be detect with the Adeno Respi-Strip?

The Adeno Respi-Strip test has been optimised in such a way that it can detect Adenovirus in respiratory samples in terms of quantity of virus and in terms of sample type. If you use the faecal test, you will face detectability problems.

 

Info
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