cobas^® MPXV

For the qualitative detection of MPXV DNA on cobas^® 6800/8800 Systems

Respond with confidence to this public health emergency

Monkeypox virus (MPXV) have been declared a Public Health Emergency of International Concern (PHEIC) by WHO (23Jul2022) and Biden administration (04Aug2022). Combine the high quality, dual target, moderately complex cobas^® MPXV test with the transformative automation that the cobas^® 6800/8800 Systems provide to respond with confidence to this public health emergency.

Symptoms of monkeypox include fever, chills, headaches, muscle aches, fatigue, swollen lymph nodes and a painful rash that characteristically appears as raised bumps on the skin and tends to be distributed on the face, extremities and genitals. As the disease progresses, these bumps fill with pus and fluid and become umbilicated. They will eventually ulcerate, scab and fall off. ¹
cobas^® MPXV for use on cobas^® 6800/8800 Systems is the first monkeypox virus test granted EUA following evaluation in actual patient samples rather than just samples formulated in the laboratory..
cobas^® MPXV targets two different regions of the MPXV genome which are both less prone to mutations than other parts of the genome. This dual-target approach ensures that cobas^® MPXV will continue to detect the virus even if a mutation occurs in one target region.
High-throughout solutions enable rapid results, allowing individuals to avoid additional testing or unnecessary isolation, and supporting access to appropriate treatment as soon as possible.

It takes more than just a single target

Target channel 1

Detection of MPXV nucleic acids

MPXV-specific nucleic acid sequences from the double stranded RNA-binding protein and the membrane-associated glycoprotein genes in the FAM channel for MPXV detection.

Target channel 2

Detection of the human b-globin gene

Endogenous control HBB Hemoglbin subunit b. Conserved sequences of the human b-globin gene in the HEX channel to provide a sample adequacy control.

Channel of the internal control (IC)

Assay validity

Internal control to monitor the entire sample preparation and PCR amplification process. Detection in the CY5.5 channel.

External run controls

Run validity

A positive and a negative control is included for each batch to guarantee validity of each run/ batch.

cobas^® MPXV assay specifications

Sample types and collection media
Lesion swab samples collected in:
- • Copan Universal Transport Medium™ System (UTM^®) or
- • BD™ Universal Viral Transport System (UVT)
Minimum amount of sample required

0.6 mL^*
Sample processing volume

0.4 mL
Test duration

Results are available within less than 3.5 hours after loading the sample on the system.
Kit size

192 tests
Shelf life

12 months
Open-kit stability

90 days with a maximum of 40 runs
Limit of detection

36.5 cp/mL (6.4E-03 TCID₅₀/mL)

* A dead volume of 0.2 mL was identified for cobas omni Secondary tubes when performing the workflow according to the IFU. Other tubes compatible with cobas^® 6800/8800 Systems (consult the User Assistance Guide) may have different dead volume and require more or less minimum volume.

Intended use

Emergency Use Authorization

cobas^® MPXV for use on the cobas^® 6800/8800 Systems (cobas^® MPXV) is a real-time PCR assay for the qualitative detection of DNA from Monkeypox virus in human lesion swab specimens from individuals suspected of monkeypox infection by their healthcare provider.

Results are indicative of the presence (positive results) or absence (negative results) of monkeypox virus (clade I/II) DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.

Negative results must be combined with clinical observations, patient history, and epidemiological information.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42.U.S.C. §263a, that meet requirements to perform moderate or high complexity tests. Laboratories within the United States and its territories are required to report test results to the appropriate public health authorities. cobas^® MPXV is only for use under the Food and Drug Administration’sEmergency Use Authorization.

Registration status

Emergency Use Authorization

Disclaimer

cobas^® MPXV for use on the cobas^® 6800/8800 Systems is approved for use under the Emergency Use Authorization (EUA) by FDA.

This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratories;
This product has been authorized only for the detection of nucleic acid from monkeypox virus, not for any other viruses or pathogens; and
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

cobas® MPXV

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