Performance Stability Test Report of Biori Lyophilized Products

For our customers, we now mostly transport our liquid products after lyophilization. This is to lower the shipping cost and reduce risk of product failure when the storage temperature is out of limit during international transportation. But how do we know the performance of our lyophilized product and are they still stable after one-year storage at room temperature?

We take two of our products to test and verify: FMD5084-4 Fast Direct RT Premix kit with UNG and FM5134 Neoscript RT Premix kit with UNG.

FMD5084-4 premix kit is used for direct detection of target gene fluorescence quantification (TaqMan probe method) RNA amplification without the need of nucleic acid extraction and purification of samples. Its rapid DNA polymerase amplification rate is no less than 1 kb/10 secs. Below is the photo showing the sample stored at room temperature for one year.

The appearance is obviously not enough to demonstrate the product performance. So we set up amplification experiment on them as following:

Below is the result of the experiment.

The blue curves show the performance of our product before lyophilization. And the red curves show the performance after lyophilization and store at room temperature for one year.

For CT value, we come up with following data:

FM5134 premix kit is used for one-step RT-PCR qualitative and quantitative reactions by fluorescence quantitative probe method. It has a more stable amplification effect on the template of threshold concentration, making it suitable for use in high sensitivity molecular diagnostic reagents.

For this product, we also take picture of it after lyophilization and stored at room temperature for one year.

We set up amplification experiment on them as following:

Test result is as following:

Still, the blue curves show the performance of our product before lyophilization. And the red curves show the performance after lyophilization and store at room temperature for one year.

Above data shows that our products are stable for at least one year after lyophilization. We also have experiment result for our other products and they are available upon request.