PCR Diagnostic Testing Kits, Vaccine Storage Freezers, and Thermal Cyclers for Infectious Disease Diagnostics

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Considerations for COVID-19 PCR Diagnostic Test Kits and RT-PCR Testing Equipment

Vitro diagnostics test kits allow a qualitative test for the detection of nucleic acid from SARS-CoV-2 within nasopharyngeal, oropharyngeal, nasal, and mid-turbinate nasal swab specimens. The SARS-CoV-2 nucleic acid is generally detectable in upper and lower respiratory specimens during the acute phase of infection.

The FDA recognizes two types of diagnostic tests used for SARS-Cov-2 detection including molecular tests such as RT-PCR tests that detect the virus’s genetic material and antigen tests that detect specific proteins expressed by the virus.

For RT-PCR tests, SARS-CoV-2 nucleic acid is first extracted, isolated, and purified from swab specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized real-time PCR instrument.

GeneFinder COVID-19 Plus RealAmp PCR Diagnostic Test Kit by Osang Healthcare

The GeneFinder™ COVID-19 Plus RealAmp Kit is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test.

The RealAmp Kit includes the following FDA authorized materials including the COVID-19 Plus Reaction Mixture, COVID-19 Plus Probe Mixture, COVID-19 Plus Positive Control, and COVID-19 Plus Negative Control.

The one-step, real-time RT-PCR kit detects SARS-CoV-2 in 120 minutes in a single tube and completes 96 reactions in under 4 hours. The triple gene target test covers genetic drift and drug pressure. All components of the kit must be stored at -20°C upon arrival.

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GeneFinder COVID-19 Plus RealAmp Kit for Healthcare Providers

Covid 19 Diagnostic Testing Equipment

Molecular assays based on polymerase chain reactions (PCR) require thermal cyclers for pathogen and infectious disease detection. Real-Time Quantitative Reverse Transcription PCR is a major development of PCR technology that enables reliable detection and measurement of products generated during each cycle of the PCR process.

Thermal Cycler Limitations and Performance Indicators

Ramp rates, thermal overshoot, and other thermal cycling characteristics are key indicators of thermal cycling performance. Ramp speed, typically expressed in °C/second, will dictate the overall speed of the PCR run. The temperature ramping speed of most economical thermal cyclers is relatively slow (2 to 3°C/s) so a polymerase chain reaction can take 1 to 2 hours.

Advantages of Next Generation Thermal Cyclers

Advanced thermal cyclers, such as the qTOWER 3, provide much faster ramp speeds with a heating rate of up to 8 °C/sec (max.) and cooling speed of up to 6 °C/sec (max.) The result is rapid, accurate, qualitative COVID-19 test results in under 90 minutes.

QTOWER 3 Thermal Cycler Features & Advantages

The qTOWER 3 easily adapts to a variety of available filter modules and emission filters that facilitate various excitations and read-out wavelengths for detecting various fluorescent dyes. An optional Gradient Function allows programmable temperature specificities and easily adjusts for different assays by defining temperature in whole numbers for simple and intuitive operation. Optional QPCTsoft enhances PC control or provides stand-alone operation via integrated tablet control (select models), license-free, multilingual software covers a broad range of analysis tools

Shop PCR Thermal Cyclers online at Terra Universal for in-stock, ready-to-ship models.

Vaccine Storage Freezers

Terra Universal is a manufacturer of specialized environmental control products and also an authorized distributor of leading scientific storage and vaccine freezers from trusted brands including Thermo Fisher, Helmer Scientific, Marvel Scientific, and Binder.

Traditional Vaccine Storage Requirements

Vaccine storage temperatures are crucial environmental controls between the manufacturing and delivery of vaccines. Terra Universal provides both large-scale and undercabinet vaccine storage freezers and refrigerators which can support storage for various vaccines, PCR kits, biological samples, and reagents.

Refrigerated Vaccine Storage

Most vaccine storage refrigerator temperatures range between 36˚F - 46˚F (2.2˚C - 7.7˚C) usually with an ideal CDC recommended temperature of 40˚F. Vaccine refrigerators allow controlled, low-temperature storage for short term storage and thawing. Some vaccines, such as the Pfizer COVID-19 vaccine allow optional storage conditions in either a freezer or refrigerator. The downside is that when stored in refrigerators, the shelf life may be limited. The Pfizer vaccine refrigerated between 36°F and 46°F has a limited beyond-use-date (BUD) of only 5 days.

The Horizon Series-GX from Helmer Scientific is a pharmaceutical-grade storage refrigerator designed to store vaccines, chemotherapy drugs, and pharmaceutical products.

Read More: Vaccines Storage and Handling Toolkit | CDC

COVID-19 Vaccine Storage Freezer Temperatures

Ultra-low temperature vaccine freezers provide safekeeping for the frozen Pfizer COVID-19 vaccine storage, as well as -20 C freezers appropriate for Moderna vaccine storage. Vaccine storage freezers are designed specifically to maintain constant low-temperature ranges and prevent small temperature fluctuations that can destroy costly sensitive samples. COVID-19 vaccines and SARS-CoV-2 diagnostic reagents may require dark storage at temperatures below -20°C.

Pfizer Vaccine Storage

According to CDC vaccine storage guidelines, there are three options for storing Pfizer-BioNTech COVID-19 vaccine. It may be stored in:

1. Ultra-cold freezer between -80°C and -60°C (-112°F and -76°F) up to the expiration date. Keep vaccine vials upright and in their tray and protect them from light.
2. Thermal shipping container using the Controlant Temperature Monitoring Device (TMD). Maintain the appropriate temperature by adding dry ice to the shipping container according to the manufacturer’s guidance. Keep vaccine vials upright and in their tray and protect them from light.
3. Refrigerator between 2°C and 8°C (36°F and 46°F) for up to 5 days (120 hours).

Related: Pfizer-BioNTech COVID-19 Vaccine Information | CDC

TSX Series Undercounter High-Performance Lab Refrigerators

Designed to safely store medical and laboratory products requiring a temperature range of 2° to 8°C. Touchscreen interface and USB-downloadable data storage; temperature and event data is stored on-board for 15 years.

Ultra Low-Temperature Storage

Moderna Vaccine Storage Freezers

As of 12/20/20, the CDC recommends Moderna vaccine storage in a freezer between -25°C and -15°C (-13°F and 5°F). Notably, the vaccine freezer temperature requires a tight temperature range threshold and may require careful adjustment of the freezer to achieve the correct temperature range.

The i.Series Upright ULT Freezers by Helmer Scientific feature the i.C3 User Interface that provides constant temperature monitoring and control, security, and multi-information logs. An ice-resistant sealing surface features an energy-efficient hot gas loop for a frost-free door frame and composite panels reduce heat transfer.

TLE Series Ulta-Low Freezers by Thermo Scientific include a newly re-designed, capacitive touch-screen user interface with an easy-to-use set-up wizard, event log, temperature mapping, and USB data downloads. DeviceLink™ comes embedded in your ULT freezer providing real-time monitoring of system status and sample temperature.

Revco™ Enzyme Freezers by Thermo Fisher Scientific

The Revco UxF Series offers ultra-low storage temperatures down to -86°C with features including 24/7 monitoring of internal conditions; touchscreen display allows easy changes to settings, temperature logging, and user entry authority levels.

i.Series Upright ULT Freezers by Helmer Scientific

TLE Series Ulta-Low Freezers by Thermo Scientific

Revco™ Enzyme Freezers by Thermo Fisher Scientific

Where to Buy Vaccine Refrigerators & Freezers

Terra Universal is an authorized distributor of trusted brands including Thermo Fisher, Helmer Scientific, Marvel Scientific, and Binder. High-volume upright and chest models allow up to 40 cubic feet for bulk storage, whereas undercounter models as 3 cubic feet support small laboratory and outpatient clinical settings.

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