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FREQUENTLY ASKED QUESTIONS

GENERAL 

1. What can I do if I get invalidated results?

 

     

           All Sample Type Checklist

 

     

           Whole BloodSample Type Checklist

 

     

           Oral-Nasal-Ocular Sample Type Checklist

 

     

           Feces Sample Type Checklist

 

     

 

 

SAMPLE PREPARATION PROCEDURE

Whole Blood Sample Preparation

 

   

1. What type of blood collection tube should I use for whole blood sample?

 

2. How can I make sure that the centrifuge step is complete and succeeded?

 

 

3. What can I do if I drop the extraction tube after centrifuging the tube 1 & tube 2?

 

4. How can I prepare the tube 1?

 


5. Which tube should I heat up?

 


6. How can I avoid the precipitate when extracting nucleic extraction kit from the tube 2?

 


 

 

 Oral-Nasal-Ocular Sample Preparation

 

 

 

1. How can I collect the sample?

 

 

 

2. Where can I add in the sample?

 

 

3. How can I dilute the sample inside of bottle?

 

 

 

4. How to extract the nucleic acid extraction from the bottle?

 

 

 

 

 

 Feces Sample Preparation

 

 

 

1. What is the amount of feces needed to run the test?

 

 

 

2. How to extract the sample from the tube?

 

 

3. Why no nucleic acid extraction comes out of the tube when squeezing?

 

 

 

 

 

REAGENT TUBE PREPARATION 

1. What can I do if the reagent ball is not at the neck of the reagent tube?

 

     

2. How long should I centrifuge the reagent tube?

 

     

3. What can I do if I drop the reagent tube after centrifuging?

 

   

4. What items should be checked before putting the reagent tubes in the reaction well?

 

   

 

 

MAINTENANCE 

1. How should I clean the QubeMDx instrument?

 

     

2. How should I dispose of used reagent kits?

 

     

3. What should I do if the reagent tube is opened during or after the reaction?

 

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1. What can I do if I get invalidated results?

Please check the following items for the cause of invalidated results:

 

 

 

 

 

 

All Sample Type Checklist

  • Is the operator wearing gloves at all time?
  • Is the package undamaged before the usage?
  • Is the reagent tube pouch opened right before adding in the nucleic acid extraction?
  • Is the temperature profile selected for the specific disease?
  • Are there any abnormalities regard the interface of the QubeMDx device? For example, symbol like
  • Are there abnormal alarm sounds generated when operating QubeMDx device?
  • Are the following items checked before putting the reagent tube into the reaction well?
    • There is no bubble inside after centrifuging for 1 minute.
    • The fluid level is within the matte line.
    • The fluid inside the reagent tube is clear and colorless.
  • Is the reagent kit used still within the validated date?
  • Are the reagent kits stored under room temperature? (Should avoid refrigeration)

 

 

 

 

 

 

Whole Blood Sample Type Checklist

  • Only use fresh or whole blood sample collected in the EDTA collection tube.
  • Remove first the upper red silicon cap, then the lower red silicon plug of the sample collection column before putting the sample collection column into the tube 1.
  • No remaining fluid inside or attached to the sample collection column after centrifuging the tube 1 for 1 minute.
  • Transfer the sample collection column from the tube 1 into the tube 2 and add the buffer into the column before proceeding to the next step.
  • Heat up the tube 2 for 6 minutes before centrifuging the heated tube 2 for 1 minute.
  • The precipitate should be avoided when extracting the nucleic acid extraction from the tube 2.

 

 

 

 

 

 

Oral-Nasal-Ocular Sample Type Checklist 

  • Only follow the guide of the sample collection to avoid failure.
  • Rotate the swab sample inside the buffer in the bottle for 10 times.
  • Invert the buffer bottle with sample inside for 3 times.
  • Squeeze around 5ml (10 drops) of the nucleic acid extraction out of the buffer bottle.

 

 

 

 

 

 

Feces Sample Type Checklist

  • The amount of feces sample is appropriate.
  • The buffer is added to the feces extraction tube before adding in the sample.
  • A 5 minutes waiting time is given to the feces extraction tube before squeezing out the nucleic acid extraction.
  • The nucleic acid extraction is squeezed from the lower(smaller) cap of the feces extraction tube.

 

 

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1. What type of blood collection tube should I use for whole blood sample?

Please select EDTA tubes to collect whole blood sample which are compatible with QubeMDx detection kits. Other types of tubes contain substances that will affect the PCR reaction and should not be used.

 

 

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2. How can I make sure that the centrifuge step is complete and succeeded?

After centrifuging, there will be no remaining fluid inside and attached to the sample collection column.

 

Picture1

 

Please centrifuge again until the fluid is all down to the bottom.

 

 

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3. What can I do if I drop the extraction tube after centrifuging the tube 1 & tube 2?

Please centrifuge again and then follow the normal steps.

 

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4. How can I prepare the tube 1?

Take out the tube1 and the sample collection column from the package.

Remove first the upper red silicon cap, then the lower red silicon plug of the sample collection column.

Afterward, put the sample collection column into the tube 1. The tube 1 is ready to proceed to the next step.

 

Picture2

 

 

 

 

 

 

 

 

 

 

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5. Which tube should I heat up?

After transferring the sample collection tube from the tube1 to the tube 2, add the lysis buffer inside the column and heat up the tube 2.

After heating up the tube 2 at 98oc for 6 minutes, please centrifuge the tube 2 for 1 minute.

 

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6. How can I avoid the precipitate when extracting nucleic extraction kit from the tube 2?

The precipitate will gather to one side of the tube2 bottom. Please put the tip close to the other side of the tube2 bottom when extracting.

 

Picture3

 

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1. How can I collect the sample?

Please refer to the Guideline: Oral-Nasal-Ocular Swab Sample Collection.

 

 

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2. Where can I add in the sample?

Please screw open the lower cap of the buffer bottle and add the sample in.

 

 

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3. How can I dilute the sample inside of bottle?

Rotate the swab sample inside the buffer 10 times, then recap and invert the buffer bottle 3 times.

 

 

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4. How to extract the nucleic acid extraction from the bottle?

Please screw open the upper cap the buffer bottle and squeeze out the nucleic acid extraction, the recommended volume is about 0.5ml (10 drops).

 

 

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1. What is the amount of feces needed to run the test?

The proper amount of feces sample required to perform the test successfully is less than 5mg (see image below). Too much sample might affect the quality of DNA extracted and the results.

 

 Screen Shot 2019 09 20 at 2.16.45 PM  

Screen Shot 2019 09 20 at 2.16.36 PM 

 

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2. How to extract the sample from the tube?

After diluting the sample in the buffer inside the feces extraction tube, screw back and shake for 5-10 times. After letting it stay for 5 minutes, shake the tube again before squeezing out the nucleic acid extraction.

Please screw open the lower(smaller) cap of the tube to extract the nucleic acid extraction.

 

Screen Shot 2019 11 06 at 11.45.57 AM

 

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3. Why no liquid comes out of the tube when squeezing?

Please try the following options to better squeeze the tube:

 

Screen Shot 2019 11 06 at 11.44.25 AM 

 

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1. What can I do if the reagent ball is not at the neck of the reagent tube?

Shake lightly the reagent tube to reposition the ball. Open the reagent tube only if the ball is in the correct position.

 

Screen Shot 2019 11 06 at 2.23.56 PM

 

 

 

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2. How long should I centrifuge the reagent tube?

Please centrifuge fore 1 minute. Extra centrifuging time is acceptable as long as there is no bubble inside the tube.

 

 

 

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3. What can I do if I drop the reagent tube after centrifuging?

Please confirm first that the cap is still tightly sealed. Centrifuge again and confirm there is no bubble inside.

 

 

 

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4. What items should be checked before putting the reagent tubes in the reaction well?

Please check the following items:

     1. There is no bubble inside after centrifuging for 1 minute.

     2. The fluid level is within the matte line.

 

Screen Shot 2019 11 06 at 2.26.53 PM

 

     3. The fluid inside the reagent tube is clear and colorless.

 

Screen Shot 2019 11 06 at 2.28.25 PM

 

     4. The temperature profile of the QubeMDx device is selected for the reagent tube disease target.

 

 

 

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