Helix Elite Molecular Standards are used as controls for developing, validating, and monitoring molecular instruments and assays. These specialized biological controls support molecular technology developers and users in meeting regulatory requirements and providing confidence in their test.

From assay development to routine quality control, SARS-CoV-2 research materials and IVD controls from Microbiologics combine precision with the convenience of user-friendly formats. The Microbiologics Virology Team (formerly Virapur) has been working with our customers since the outbreak of COVID-19 to develop solutions for the challenges of this new coronavirus.

Process Controls

Synthetic RNA encapsulated in a phage protein envelope containing diagnostically relevant SARS-CoV-2 genomic targets - Orf 8/RdRP/S/M/E/N Gene Targets

• HE0062S   Inactivated SARS-CoV-2 Whole Virus (Pellet)
• HE0063S   Inactivated SARS-CoV-2 Whole Virus (Swab)

IVD Controls

SARS-CoV-2 IVD Controls for COVID-19 Testing

• HE0060S SARS-CoV-2 Synthetic RNA (N1,N2 & N3 Gene Targets)
• HE0061S SARS-CoV-2 Synthetic RNA (N/E/RdRp/S Gene Targets)

Negative Control Containing A549 Lung Epithelial Cells

• HE0058N Negative Cellularity Control (Inactivated Pellet)
• HE0067NS   Negative Cellularity Control (Inactivated Swab)

RUO SARS-CoV-2 Materials

SARS-CoV-2 Process Controls for COVID-19 Testing

• R9000 RUO SARS-CoV-2 Process Control (Pellet)
• R9001 RUO SARS-CoV-2 Process Control (Swab)

SARS-CoV-2 RUO Synthetic RNA

• 9009 SARS-CoV-2 Synthetic RNA (N Gene Targets, 1 x 109 genome copies per tube)
• 9019VP SARS-CoV-2 Synthetic RNA (E/RdRp Gene Targets, 1 x 109 genome copies per tube)
• 9029VP SARS-CoV-2 Synthetic RNA (S Gene Targets, 1 x 109 genome copies per tube)