Sansure Measles virus, Rubella virus, and Mumps virus PCR Detectio Kit

The Sansure Biotech Masern (MeV), Rubella (RV), and Mumps (MuV) Virus Nucleic Acid Diagnostic Kit is a multiplex real-time reverse transcription polymerase chain reaction (RT-qPCR) assay developed for the qualitative detection of nucleic acid from MeV, RV, and MuV in oropharyngeal swabs, whole blood, and saliva specimens. Using fluorescence probing, this kit enables sensitive and specific identification of viral RNA, aiding the early diagnosis of measles, rubella, and mumps infections.

This assay is intended for in vitro diagnostic (IVD) use by trained clinical laboratory professionals and supports the diagnosis of viral infections in symptomatic individuals. It is not intended as the sole basis for clinical decisions but as a complement to other diagnostic and clinical information.

Key Features

• Multiplex Detection: Simultaneously identifies Measles, Rubella, and Mumps RNA in a single assay.
• Internal Control (IC): Human GAPDH gene target ensures sample integrity and minimizes false negatives.
• High Sensitivity: Limit of detection is 500 copies/mL.
• Validated on Major PCR Platforms: Compatible with ABI 7500, QuantStudio™ 5, Roche LightCycler® 480, MA-6000, and SLAN®-96P.
• Comprehensive Control System: Includes positive and negative controls to ensure result validity.
• Minimal Interference: Proven robustness against common interfering substances (e.g., hemoglobin, bilirubin, triglycerides, common antivirals).

Kit Components

Required but not provided:

• PCR tubes/strips, microcentrifuge tubes, filtered pipette tips 
  

Test Workflow Summary

1. Specimen Collection & Processing:
   • Sample Types: Oropharyngeal swab, saliva, or whole blood
   • Extraction using Sansure’s Nucleic Acid Extraction Kit
   • Storage: ≤24 hours at 4°C; ≤10 days at -20°C; long-term at -70°C
2. Reaction Setup:
   • PCR master mix: 26 µL PCR Mix + 4 µL Enzyme Mix per reaction
   • Add 30 µL Master Mix + 20 µL extracted RNA per tube
3. PCR Program:
   • RT: 50°C for 30 min
   • Pre-denaturation: 95°C for 1 min
   • Amplification: 45 cycles of 95°C for 15 sec → 60°C for 30 sec
4. Fluorescence Channels:
   • FAM: Measles Virus
   • ROX: Rubella Virus
   • CY5: Mumps Virus
   • HEX/VIC: Internal Control
5. Interpretation Criteria:
   • Ct ≤ 40: Positive
   • No Ct or Ct > 40 + IC valid: Negative
   • No Ct for both target and IC: Invalid, repeat test

Quality Control and Performance

Compatible Instruments

• Applied Biosystems 7500
• Thermofisher QuantStudio™ 5
• Roche LightCycler® 480 II
• MA-6000 Real-Time PCR
• SLAN®-96P

Storage and Stability

• Storage Conditions: -20 ± 5°C, protect from light
• Shelf Life: 12 months (unopened); ≤3 freeze-thaw cycles allowed
• Shipping: Valid up to 7 days at <20°C in foam box with coolant

Safety and Handling

• IVD use only; trained personnel required
• Follow local biosafety and biohazard disposal protocols
• Separated work areas for reagent prep, sample processing, and PCR required
• Use of PPE (gloves, coats) mandatory to avoid contamination

Ordering Information