FDA EUA Monkeypox qPCR Test Kit

Accurately detects monkeypox (mpox) by qPCR.

FDA EUA (Emergency Use Authorization) Product

CE/IVD Marked Product

Research Use Product

The gold standard qPCR test directly detects the presence of the mpox (monkeypox) viral DNA. By detecting the two virus-specific genes, J2L and B6R, using the human RNase P as a control, our qPCR multiplex assay can detect the targets and control in one reaction tube.

The design allows detection of the virus even if part of one gene is deleted in a variant. Validated on commonly used instruments such as ABI 7500 Fast Dx, ABI QuantStudio 5, Bio-Rad CFX 384, and Roche Lightcycler 480II with a detection limit of 25 to 80 copies/ml sample, any CLIA lab can validate this test.

FDA Emergency Use Authorization (EUA) Authorized

Download FDA Letter of Authorization

Sensitivity

The detection limit of the test ranges from 25 to 80 copies/ml of sample, depending on the instrument used.

Validated Machines

Unlike other vendors, we validate the test on the most commonly used qPCR instruments so you can easily pick one qPCR instrument in your own lab for CLIA validation. Our validated instruments include:

ABI 7500 Fast Dx
ABI QuantStudio 5
Bio-Rad CFX384
Roche LightCycler 480II

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Notes and Comments

Mpox Virus and Infection

The Spreads of Mpox Virus

Detected in May 2022, mpox viruses have spread in many countries. The mpox virus can spread from person to person through close, personal, or intimate contact. The media for the spreads include:

Body fluids and respiratory secretions
Touching surfaces and objects
Body contact and sex

Symptoms of Mpox

The most obvious symptoms are itchy and painful rash appearing at different parts of the body after 1 to 4 days after infection. In addition, the patient may have flu-like symptoms such as chills, fever, headache, and aches in muscle or back.

Importance of Testing

Testing for mpox protects the patient and loved ones and stops the spreading of the virus further in the community. Currently, the CDC only recommends mpox testing when a rash consistent with mpox appears.

*This product configuration image only shows the 24-reaction and 48-reaction pack size. 480-reaction pack size has 7 vials.

Product Configuration

Kit Components

Master mix
Primer/probe mix (J2L, B6R & Human RPP30 gene primers and probes)
Positive Control (PC), Extraction Control (EC) and No Template Control (NTC)

Pack Size

24-reaction per kit, 48-reaction per kit, 480-reaction per kit

Ordering Information

FDA EUA Authorized

Product Name: QuantiVirus™ MPXV Test Kit

24-Reaction Kit Catalog Number: DC-04-0009
48-Reaction Kit Catalog Number: DC-04-0005
480-Reaction Kit Catalog Number: DC-04-0006

Storage of kits is proposed to be at -25°C to -15°C. Based on individual component shelf life, the shelf life of the kit is 13 months. Do not use expired reagents from the kit.