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Abbott RealTime RT-PCR Assay — Molecular Diagnostic

Abbott RealTime RT-PCR Assay — Product Description

The Abbott RealTime RT-PCR Assay is a molecular diagnostic test using real-time reverse transcription polymerase chain reaction (RT-PCR) to detect viral nucleic acid (RNA) with high analytical sensitivity and specificity. Abbott's RealTime family includes assays for respiratory pathogens (e.g., SARS-CoV-2) intended for qualitative detection of target nucleic acid in validated specimen types.

Molecular RT-PCR assays are considered the reference standard for detecting active infection because they directly detect pathogen genetic material. Abbott’s RealTime assays are designed for laboratory or point-of-care molecular platforms and are used where high sensitivity and reliable detection are required for patient management and public-health surveillance. Always follow the specific assay IFU for specimen types, run times, and interpretation guidance. :contentReference[oaicite:5]{index=5}

Key Features :

  • Real-time RT-PCR — qualitative detection of target viral RNA with high sensitivity.
  • Suitable specimen types commonly include nasopharyngeal, oropharyngeal, nasal swabs, and lower respiratory samples (confirm for the chosen assay).
  • Laboratory/reagent kit format for use on Abbott molecular instruments — refer to platform compatibility.
  • Intended for clinical diagnosis, patient management, and surveillance when used per IFU and regulatory authorizations.
  • Requires trained personnel and appropriate molecular lab setup for extraction and amplification steps (instrument-dependent).
Abbott RealTime RT-PCR Assay — Specifications
Estimated Delivery
Varies by supplier and local stock (consult your Abbott representative)
General
Product
Abbott RealTime RT-PCR Assay (molecular)
Test Type
Real-time reverse transcription PCR (RT-PCR)
Target
Pathogen nucleic acid (assay-dependent; e.g., SARS-CoV-2)
Specimen
NP/OP/nasal swabs, BAL, other validated specimen types (confirm per IFU)
Performance & Safety
Sensitivity
High analytical sensitivity (assay- and platform-dependent)
Specificity
High specificity when used per IFU
Turnaround
Instrument/run dependent — consult platform docs
Lab Requirements
Molecular lab or authorized point-of-care platform; trained personnel required
Important

RT-PCR molecular tests detect nucleic acid and are different from antigen rapid tests (antigen tests detect viral proteins and are typically less sensitive). For assay selection, verify intended use, specimen types, instrument compatibility, and regulatory status with Abbott and local authorities. Follow the official IFU and quality controls for reliable results. :contentReference[oaicite:6]{index=6}