Dear Stanley,

The items from my recent order were shipped to me without an ice pack. The temperature here was almost 80°F when the product arrived. Can I still use the items or do I have to re-order?

Franklin, Fort Myers

Hi Franklin!

Answer: Your QC product from Microbiologics should still perform as expected if the exposure to temperatures outside of our recommended range was limited.

Microbiologics recommends that our quality control microorganisms be stored between 2-8°C (~36-46°F). However, we understand that there may be instances where the products are exposed to temperatures above 8°C for brief periods of time. For instance, your refrigerator broke in the middle of the night when your lab was closed and by the time it was noticed, the temperature had risen and was out of range.

Microbiologics has performed numerous studies to determine the temperature limits our products can be exposed to without impacting performance.  Studies included shipping our products at ambient temperatures to warm climates, shipping product back to our headquarters and testing it exactly as our customers would. According to our data, our qualitative products such as the KWIK-STIK™ and LYFO DISK™ formats can withstand temperatures of up to 35°C for a period of seven days with no negative impact on performance.  Our quantitative products, such as the EZ-Accu Shot™ and Epower™ formats, can withstand temperatures of up to 30°C for five days.

Data collection also shows unassayed DNA/RNA products including Helix Elite™ Synthetic Standards, Helix Elite™ Inactivated Standards, and QC Sets and Panels (Inactivated Swabs and Pellets) do not experience a significant Ct shift when exposed to temperatures of up to 43°C for a period of 28 days.

Data collection shows the following assayed QC Sets and Panels (Inactivated Swabs and Pellets) products do not experience a significant Ct shift when exposed to temperatures of up to 43°C for a period of 28 days.

• 8193 BD MAX™ CT/GC/TV 20-Day QC Panel
• 8202 BD MAX™ Enteric Parasite 20-Day QC Panel
• 8204 BD MAX™ Enteric Parasite Control Panel
• 8194 Cepheid Xpert® GBS LB Control Panel
• 8195 Cepheid Xpert® MRSA NxG Control Panel
• 8196 Cepheid Xpert® SA Nasal Complete Control Panel
• 8188 Cepheid Xpert® CT/NG Control Panel
• 8200 Cepheid Xpert® C. difficile/Epi Control Panel

Knowing that our products can sustain brief deviations outside our recommended temperature range, we utilize two-day shipping for all our domestic shipments with no added ice packs or dry ice, unless otherwise requested. We choose to ship our products this way because saves our customers money. If you have any questions or concerns about specific temperature excursions, please reach out to the experts on our Technical Support Team at techsupport@microbiologics.com or +1.320.229.7045.

Sincerely,

Stanley