Intended Use

a lyophilized, ready-to-use, open format, duplex Real Time Reverse Transcription Polymerase Chain Reaction (RT PCR) test for the qualitative detection of SARS CoV-2 RNA in human oropharyngeal and nasopharyngeal swabs and aids in the diagnosis of COVID-19. The test detects the E and Orf1a genes of the virus. Truemix COVID-19 runs on standard Real Time PCR analyzers

Key Features

• Assay based on Taqman chemistry
• lyophilized, ready-to-use, open format
• Simple, one step procedure. Built in process control
• Proprietary formulated RT-PCR components.
• Dried down, ready to use positive control included in the kit
• Packed as 8 tube strips, highly flexible for sample load. No wastage of reagents
• Built in amplicon cleavage mechanism. Minimal risk of amplicon contamination

Test Duration

less than 1 hour

Storage/Stability

2 – 30°C for two years

Contents of the Kit

a. Lyophilized Truemix COVID-19 tubes

b. Reconstitution Buffer

c. Positive Control (Dried Down)

d. Negative Control

e. Strip of 8 PCR Flat Caps

f. Package Insert