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Multiplex qPCR Human Virus Panel

Our Multiplex qPCR Human Virus Panel delivers rapid and reliable detection of 22 common human viral contaminants using a highly sensitive and validated real-time PCR platform. This service is optimized for biologics, vaccines, and cell therapy products, enabling efficient lot release testing, contamination screening, and biosafety evaluations. With short turnaround times and compatibility with GMP/GLP workflows, it provides a cost-effective solution for routine viral safety assessments across the development pipeline.

Adventitious Viruses

Virus Acronym

Virus Name

HAV

Hepatitis A

HBV

Hepatitis B

Hepatitis C

HCV

HCMV

Human Cytomegalovirus

HSV1

Herpes Simplex Virus type 1

HSV2

Herpes Simplex Virus type 2

PCV2

Porcine circovirus type 2

SV40

Simian polyomavirus

SRV1

Beta retrovirus

EV

Enterovirus

EBV

Epstein-Barr virus

HTLV1

Human T-cell leukemia virus 1

HTLV2

Human T-cell leukemia virus 2

Pan HAdV

Pan Adenovirus

HHV6

Human herpes virus 6

HHV7

Human herpes virus 7

HHV8

Human herpes virus 8

HIV2

Human immunodeficiency virus 2

BK & JC

Polyomavirus isolate BK and JC

HPV16

Human papillomavirus type 16

B19

Parvovirus B19

HIV1 set1

Human immunodeficiency virus 1

HIV1 set2

Human immunodeficiency virus 1

Key Features

  • Comprehensive panel coverage: 22 human viruses
  • Quick turnaround time: 5 – 10 business days
  • High specificity
  • High sensitivity: LOD 5 – 10 copies
  • GMP/GLP compliant

Applications

The Multiplex qPCR Human Virus Panel is designed to support viral safety testing across a broad range of therapeutic and biologic workflows such as:

  • Cell/ gene therapy manufacturing
  • Raw material qualification
  • Lot release testing

Technical Specifications

Parameter

Details

Detection Method

Multiplex TaqMan® qPCR with internal amplification and extraction controls. Separate panels for RNA and DNA viruses.

Validation Status

Fully validated for sensitivity, specificity, and reproducibility. Available under GLP or GMP conditions.

Sample Types Accepted

Cell pellets, cell suspensions, and cell-free liquids

Sensitivity (LOD)

5–10 copies per reaction (target dependent). High sensitivity suitable for low-titer detection.

Sample Volume

Minimum of 1×10⁶ cells or 200 µL of cell suspension or cell-free liquid per multiplex assay. The full panel consists of multiple multiplex assays; total volume required will depend on panel configuration.

Storage & Shipping

Accepts frozen (−80°C / −20°C), refrigerated (2–8°C), or stabilized liquid samples.

Turnaround Time

Standard: 10 business days. Rush option available in 5 business days.

Deliverables

Certificate of Analysis (CoA), qPCR report with CT values, result interpretation, and QC metrics.

Regulatory Use

RUO, GLP, or GMP-compliant formats. Suitable for IND, BLA, and clinical lot release applications.

Regulatory & Compliance

Our Multiplex qPCR Human Virus Panel is fully validated to support biosafety testing in regulated environments and meets the expectations of global health authorities.

Key compliance features include:

  • GMP and GLP compliance
  • 21 CFR Part 11 compliance

Have Questions?

We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a quick message with your questions to find out what Avance can do for you.

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