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Palm PCR™ COVID-19 Fast Real-time RT-PCR Kit

Palm PCR™ COVID-19 Fast Real-time RT-PCR Kit

Palm PCR™ COVID-19 Fast Real-time RT-PCR Kit

Product catalog summary
The State of the Art COVID-19 Diagnosis
  • Ultra-fast RT-PCR Assays: Results within 50 minutes on conventional real-time PCR instruments.
  • Two Target Test: Targets E gene and RdRP gene, with one target per tube.
  • High Sensitivity & Specificity: Achieves 100% Positive Percent Agreement (PPA) and 100% Negative Percent Agreement (NPA).
  • High Throughput: Capable of processing over 368 patients (768 assays) in 8 hours, enhancing RT-PCR throughput by more than 200%.
Ultra-Fast RT-PCR Assays with Extreme Sensitivity
  • Shortest RT-PCR Time: ≤ 50 minutes on Bio-Rad CFX96 and ABI QuantStudio 5, and 58 minutes on ABI 7500 Fast.
  • Ultimate High Sensitivity: Detects as low as 5 copies/reaction of SARS-CoV-2 with a 95% hit rate. Limit of Detection (LoD) is 8.2 copies/reaction for E gene and 5.3 copies/reaction for RdRP gene.
Lyophilized Premix Format - Robust and Simple to Use
  • Provided in a lyophilized Premix containing all core components for RT-PCR assay.
  • Advantages include longer shelf life (12 months), cheaper shipping costs, ease of use, and guaranteed sensitivity and accuracy.
Assay Format and Product Components
  • Two Assay Format: Assay 1 for E gene detection and Assay 2 for RdRP gene detection, each with an internal control to prevent false negatives.
  • Product Components: Includes Premix 1 and 2, reconstitution buffer, positive and negative controls.
Medical Device Certifications
  • KFDA Approved: Product License No. IVD-20-569.
  • Mexico INDRE Approved: Oficio No. DGE-DDYR-11170-2020.
  • US FDA EUA: Under review, Submission No. PEUA201671.
  • Health Canada EUA: Under review, Submission No. 313758.
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Catalog excerpts

Palm PCR™ COVID-19 Fast Real-time RT-PCR Kit-1

Palm PCR™ COVID-19 Fast Real-time RT-PCR Kit ❖ The State of the Art COVID-19 Diagnosis ➢ Ultra-fast RT-PCR Assays: Within 50 min on conventional real-time PCR instruments ➢ Two Target Test: E gene and RdRP gene (one target per tube) ➢ High Sensitivity & Specificity: 100% PPA and 100% NPA ➢ High Throughput: Over 368 patients (768 assays) per 8 hours ➢ More than 200% Enhancement of RT-PCR Throughput ❖ Ultra-Fast RT-PCR Assays with Extreme Sensitivity ➢ The Shortest RT-PCR Time: ≤ 50 min on Bio-Rad CFX96 and ABI QuantStudio 5, and 58 min on ABI 7500 Fast (3 min for reverse transcription, 1 min for hot start, and 1 min per cycle) ➢ Ultimate High Sensitivity: Can detect down to 5 copies/reaction of SARS-CoV-2 with at least 95% hit rate (LoD: 8.2 copies/reaction for E gene and 5.3 copies/reaction for RdRP gene) Email: [email protected] | Web site: www.ahrambio.com | Tel: +82-2-469-3760 Copyright © 2020 Ahram Biosystems, Inc. All rights reserved. Revised

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Palm PCR™ COVID-19 Fast Real-time RT-PCR Kit-2

Palm PCR™ COVID-19 Fast Real-time RT-PCR Kit ❖ Assay Format and Product Components ➢ Two Assay Format: Assay 1 using Premix 1 for detecting E gene that is common to Sarbecovirus; and Assay 2 using Premix 2 for detecting RdRP gene that is specific to SARS-CoV-2 ➢ Each assay contains an internal control (IC) to exclude the possibility of false-negative results due to inefficient or false RNA extraction. Product Components Component Premix 1 for E gene (lyophilized) Premix 2 for RdRP gene (lyophilized) Reconstitution buffer Positive Control Negative Control ❖ Lyophilized Premix Format - Robust and...

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