All Diagnostic Divisions
Division III

Molecular Diagnostics & HPV Genotyping

BSL-2 compliant molecular diagnostics with real-time PCR platforms for High-Risk HPV genotyping, GeneXpert MTB/RIF tuberculosis detection, and quantitative viral load monitoring.

Real-Time PCRHigh-Risk HPV GenotypingGeneXpert MTB/RIF
Turnaround Time
4–24 hours
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Division Mandate & Scientific Scope

Operating under strict BSL-2 molecular biocontainment with unidirectional workflow zones (reagent prep, extraction, amplification/detection). Our molecular division features real-time PCR platforms and GeneXpert automated cartridge systems, with specialized protocols for High-Risk Human Papillomavirus (HPV) Genotyping, quantitative viral load monitoring, and pathogen resistance detection. The division is a designated HPV Screening & Cervical Cancer Prevention Hub, providing critical oncogenic HPV type differentiation for early-risk triage before cervical abnormalities develop.

Core Methodologies
TaqMan Probe Real-Time Fluorogenic PCRHigh-Risk HPV Oncogenic GenotypingAutomated Magnetic Bead Nucleic Acid ExtractionClosed-System Microfluidic Amplification (GeneXpert®)Multiplex Fluorescence Channel DetectionBSL-2 Unidirectional Workflow Biocontainment
Specimen Protocol

Cervical swab in liquid-based cytology medium for HPV; EDTA whole blood/plasma for viral loads; Sputum or sterile body fluid in sterile container for GeneXpert MTB.

Featured Instrumentation & Equipment Fleet

World-class clinical analyzers powering this division

Real-Time PCR & HPV Genotyping Platform

Molecular Diagnostics
Multiplex Fluorescence Real-Time Thermal Cycler
Capacity & Throughput

High-throughput 96-well amplification with multi-channel fluorescence detection.

Core Technology

TaqMan probe chemistry, melting curve analysis, and internal extraction control verification.

Key Features & Capabilities
  • High-Risk HPV Genotyping: Differentiates oncogenic high-risk HPV types (including HPV 16 and HPV 18) directly linked to cervical intraepithelial neoplasia and cervical cancer
  • Enables early risk assessment and proactive triage before cervical abnormalities progress
  • Supports outpatient clinics, gynecological screening programs, and hospital referral networks
  • Internal amplification controls on every run to verify extraction quality and prevent false negatives

GeneXpert® Automated Molecular Diagnostic System

Cepheid
Closed-Cartridge Nucleic Acid Amplification
Capacity & Throughput

Random-access on-demand processing with automated hands-off extraction and PCR.

Core Technology

Automated microfluidic sample extraction, purification, and nested real-time PCR.

Key Features & Capabilities
  • GeneXpert MTB/RIF®: Direct identification of Mycobacterium tuberculosis complex and simultaneous rifampicin resistance detection in under 2 hours
  • Closed biocontainment cartridge design preventing amplicon cross-contamination
  • Minimal hands-on time — sample-to-result in fully automated workflow

Clinical Assay Menu & Test Panels

Complete testing capabilities available in this division

Cervical Cancer Screening & Prevention

  • High-Risk HPV Genotyping Test (HPV 16, 18, and grouped high-risk oncogenic types)
  • Early Risk Assessment & Clinical Triage Screening
  • Reflex HPV DNA Confirmation Following Abnormal Cytology

Tuberculosis & Antimicrobial Resistance

  • GeneXpert MTB/RIF® — Mycobacterium tuberculosis Detection
  • Rifampicin Resistance Mutation Profiling
  • Smear-Negative TB Detection from Sputum

Quantitative Viral Load Monitoring

  • HIV-1 RNA Quantitative Viral Load
  • Hepatitis B Virus (HBV-DNA) Quantitative Real-Time PCR
  • Hepatitis C Virus (HCV-RNA) Quantitative Real-Time PCR

Respiratory & Special Pathogens

  • SARS-CoV-2 RT-PCR (Multiplex Targets)
  • Herpes Simplex Virus (HSV 1/2) PCR

Analytical Advantages & Special Capabilities

Oncogenic HPV risk stratification: "Know your status, protect your future" early detection initiative

Strict 3-room physical separation (Reagent Master Mix Room → Extraction Room → Amplification Room) guaranteeing zero contamination

Reportable linear dynamic range for viral loads spanning 20 to 10,000,000 copies/mL

Simultaneous rifampicin resistance detection with TB identification — no additional run required

Academic Partnership

MLT/MLS Student Hands-On Training

MLT/MLS students at ECUSTA work directly in the Molecular Diagnostics Laboratory under faculty supervision — performing nucleic acid extraction procedures, preparing master mixes, loading PCR plates, interpreting amplification curves, and learning biosafety protocols for BSL-2 specimen handling. This hands-on training covers real-time PCR workflow from sample receipt to clinical result reporting.

ECUSTA MLT/MLS Academic ProgramView Academic Program
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Request Testing from This Division

Submit an inquiry for Molecular Diagnostics testing, or speak with our clinical coordinator for custom panel design and assay feasibility evaluation.