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Infectious Diseases

GenePath Dx CoViDx One v2.1.1 (ICMR approved)

• Highly sensitive and specific
• Compatible with a wide variety of thermocyclers: Bio-Rad CFX96, Bio-Rad Opus, QIAGEN Rotor-Gene Q, ABI QuantStudio 5, ABI 7500 and Roche Light Cycler 480 II
• Amenable to high throughput operations
• Single tube multiplexed RT-qPCR kit using four independent targets on the Covid-19 genome (SARS-CoV-2 specific RdRP x 2 loci, N gene x 1 locus and E gene x 1 locus) to increase confidence in diagnosis and tolerance to presence of mutations at primer binding sites
• Presence of an endogenous human control gene allows process control through sample preparation

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GenePath Dx CoViQuick v2.0 - Extraction-less (ICMR approved+CE-IVD marked)

• 100% sensitivity and specificity as per the ICMR report
• Includes the proprietary ‘CoviPrep’ rapid (3 minutes) single-step (no heating) sample preparation reagent
• Fast processing including sample preparation and thermocycling
• Single tube multiplexed RT-qPCR using four independent SARS-CoV-2 specific targets (RdRP x 2, N gene x 1 and E gene x 1) to increase confidence in diagnosis and tolerance to presence of mutations at primer binding sites
• Presence of an endogenous human control gene allows process control through sample preparation

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GenePath Dx CoViDx One v2.1.1TK-Quantitative (RUO)

• Highly sensitive and specific
• Compatible with a wide variety of thermocyclers: Bio-Rad CFX96, Bio-Rad Opus, QIAGEN Rotor-Gene Q, ABI QuantStudio 5, ABI 7500 and Roche Light Cycler 480 II
• Amenable to high throughput operations
• Single tube multiplexed RT-qPCR kit using four independent targets on the Covid-19 genome (SARS-CoV-2 specific RdRP x 2 loci, N gene x 1 locus and E gene x 1 locus) to increase confidence in diagnosis and tolerance to presence of mutations at primer binding sites
• Presence of an endogenous human control gene allows process control through sample preparation
• Standards provided with the kit can be used for the quantification of SARS-CoV-2
• Secure online tool to assist with viral load calculation and data analysis

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GenePath Dx CoviFlu v2.1 (RUO)

• Highly sensitive and specific single-tube assay for efficient use of real-time thermocyclers and increased laboratory throughput.
• Compatible with most 4-color detection cyclers: Green (495-520), Yellow (535-560), Orange (590-610) and Red (645-670).
• Multiple targets (SARS-CoV-2, Influenza A and Influenza B) increase confidence in diagnosis
• Presence of an endogenous human control gene allows process control through sample preparation.

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GenePath Dx CoViDelta vME-2 RT-qPCR test kit (ICMR approved)

• Rapid identification of presumptive Omicron (B.1.1.529) Variant of Concern (VoC) based on absence of the S-gene Delta L452R mutation
• Flags both BA.1 and BA.2 sub-lineages of the Omicron VoC, aligning with the WHO guidelines of S-gene Target Failure (SGTF)
• Single tube, multiplexed assay with three confirmatory gene targets (RdRP-gene x 2 loci and N-gene x 1 locus) for SARS-CoV-2 diagnosis
• Presence of a human endogenous control allows process control through sample preparation
• Aids in prioritizing SARS-CoV-2 positive specimens with SGTF, for genomic sequencing to confirm the Omicron VoC

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GenePath Dx CoviSpeedy RT-qPCR test kit - Extraction-less (RUO)

• Includes the proprietary ‘CoviPrep’ rapid (3 minutes) single-step (no heating) sample preparation reagent
• Fast thermocycling: 38 minutes on Bio-Rad CFX96 Touch (run time may vary from machine to machine)
• Single tube multiplexed RT-qPCR using four independent SARS-CoV-2 specific targets (RdRP-gene x 2, N-gene x 1 and E-gene x 1) to increase confidence in diagnosis and tolerance to presence of mutations at primer binding sites
• Presence of a human endogenous control allows process control through sample preparation

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GenePath Dx CoViFast v2.0 RT-qPCR Kit - Extraction-less

• 100% sensitivity and specificity
• Includes the proprietary ‘CoviPrep’ rapid (3 minutes) single-step (no heating) sample preparation reagent
• Fast thermocycling: 35 minutes on Bio-Rad CFX96 Touch (run time may vary from machine to machine)
• Single tube multiplexed RT-qPCR using four independent SARS-CoV-2 specific targets (RdRP – 2 targets, N-gene – 1 target, and E-gene - 1 target) to increase confidence in diagnosis and tolerance to presence of mutations at primer binding sites
• Presence of an endogenous human control gene allows process control through sample preparation

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GenePath Dx Cytomegalovirus (CMV) qPCR test kit

• Highly sensitive and specific assay for the real time detection and quantification of Cytomegalovirus (CMV) with built-in internal control
• Four CMV target genes multiplexed into a single channel
• Short run time of less than 60 minutes
• Two channel assay with broad instrument compatibility (kit validated on the Bio-Rad CFX96, Bio-Rad Opus, QIAGEN Rotor-Gene Q, ABI QuantStudio 5, ABI 7500 and Roche Light Cycler 480 II; fluorophores compatible with most real time thermocyclers)
• Secure online tool to assist with viral load calculation and data analysis

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GenePath Dx Wastewater Monitoring Assay (RUO)

• Screening test for monitoring and assessing the prevalence of SARS-CoV-2 in waste water
• Targeted S-gene kit, with a positive selection of Delta (L452R) and Omicron (E484A) markers along with SARS-CoV-2
confirmatory targets (RdRP-gene & N-gene)
• Highly sensitive and specific
• Compatible with a wide variety of thermocyclers
• Amenable to high throughput operations
• Presence of a waste water/ sewage/ fecal contamination marker along with a spiked process control in the kit, allows process control through sample preparation
• Uses the ‘UNG/dUTP’ system to minimize the risk of PCR carry-over contamination

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