HALO™ SARS-2 Delta Omicron Direct PCR kit

Clinical samples placed in a Saline or PBS transport media are used directly for subsequent amplification. Sodium azide (up to 0,05% ) and proclines 300 and 950 (at final concentration up to 0,1%) are allowed as preservatives for transport media. HALO SARS-2 Delta&Omicron Direct PCR kit was validated for the following Real-Time PCR instruments: Mx 3005P™ QPCR System (Agilent), Rotor-Gene® 6000 (Corbett Research), Rotor-Gene® Q5/6 plex Platform (QIAGEN), CFX96™ Real-Time PCR Detection System (Bio-Rad), Mic qPCR Cycler (Bio Molecular Systems). HALO SARS-2 Delta&Omicron Direct PCR kit uses fast amplification protocol, which allows obtaining reliable results of the study in 60-80 minutes, which significantly increases the flow of laboratory tests.HALO SARS-2 Delta&Omicron Direct PCR kit allows to detect and differentiate mutations in the S-gene: del 69-70 (characteristic of strain B.1.1.529, omicron) and del 156-157 (characteristic of strain B.1.617.2, delta). The system contains sufficient reagents for 100 RT-PCR reactions. 

The sensitivity of the system is 5 genome equivalents per reaction of SARS-COV-2’ target. The cross-reactivity with other respiratory viruses was tested by using in-silico BLAST analysis. The result of the pathogen RNA amplification is detected on the HEX/VIC/Yellow, ROX/Orange, Cy5/Red channels, the result of the amplification of the internal control is detected on the FAM/Green channel. The primers and probes used in the RT-PCR assayare based on the WHO and CDC published primer and probe sequences. In addition to the Internal control, the Kit uses both Negative Control (NC), and Positive Control (PC) that monitor integrity of reagents and testing procedure accuracy. The kit with endogenous control allows to analyze the quality of biological material sampling.