Enhancing Defense Against Mpox: BioPerfectus PCR Solution


The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Advisory to notify clinicians and health departments about the occurrence, geographic spread, and sexually associated human-to-human transmission of Clade I Monkeypox virus (MPXV) in the Democratic Republic of the Congo (DRC) on December 7, 2023.

ž   Background

MPXV has two distinct genetic clades (subtypes of MPXV), I and II, which are endemic to central and west Africa, respectively. Clade IIb MPXV has been associated with the 2022-23 global outbreak. Clade I MPXV is capable of human-to-human spread but has previously been associated with non-sexual routes of transmission, and Clade I has previously been observed to be more transmissible and to cause more severe infections than Clade II.

ž   Recommendations for Clinicians and Health Departments

Clinicians should continue to consider mpox when evaluating the cause of rashes. Mpox lesions may be small, firm, rubbery, deep-seated, and well-circumscribed, or they may be large, with diffuse, centrifugal lesion distribution.

For patients with travel to DRC within 21 days of illness onset, the CDC recommends that clinicians pursue MPXV clade-specific testing starting with a consultation with state health departments for testing options (e.g., molecular testing or genetic sequencing). CDC recommends clinicians follow specimen collection guidelines (including collection of two swabs per lesion) to ensure specimen availability for testing.

ž   Recommendations for Diagnostic Testing

Public health authorities are being encouraged to enhance surveillance efforts to aid the detection of Clade I MPXV. All Laboratory Response Network laboratories and commercial laboratories using CDC’s non-variola orthopoxvirus (NVO) polymerase chain reaction (PCR) test are requested to continue submitting duplicate specimens to CDC from all patients with positive NVO PCR test results for routine MPXV clade-specific testing. This will assist with national surveillance efforts. Specimens collected from patients who traveled to DRC should be sent to CDC as expeditiously as possible. Some non-CDC laboratories may also have options (e.g., molecular testing or genetic sequencing) available for clade-specific testing. Laboratories should alert their state health department and CDC if they detect Clade I MPXV.

ž   BioPerfectus Mpox PCR Solution

Monkeypox Real Time PCR Kit (CE-IVD), validated by the Armed Forces Biomedical Research Institute (INSTITUT DE RECHERCHE BIOMEDICALES DESARMEES), has undergone thorough testing. In conclusion, both positive and negative controls have been validated, allowing interpretation of the results. The kit is capable of detecting primary MPXV samples, early and late Ct. Notably,  the kit does not detect the DNA of the CPXV virus. It enables detection up to an equivalence of 4 PFU/ml of DNA from an MPXV culture supernatant.

Monkeypox Virus Genotyping Real Time PCR Kit (CE-IVD) is designed to genotype Clade I MPXV and Clade II MPXV.

Monkeypox Virus and Orthopoxvirus Real Time PCR Kit (CE-IVD) offers results of orthopoxvirus and Mpox at one test.

Monkeypox Virus/Varicella-zoster Virus/Variola Virus Real Time PCR Kit (CE-IVD) offers to distinguish causes of rashes.

Monkeypox Virus (MPXV) Fast Real Time PCR Kit (CE-IVD) offers rapid results within 50 minutes

Monkeypox Real Time PCR Kit (Veterinary use) can be used in the veterinary field.

-       Specimen types

The specimen could be obtained from Lesion Exudate / Scab / Whole Blood / Serum / Nasopharyngeal Swab / Human Tonsillar Swab.

-       Validated PCR Platforms

BioPerfectus STC-96A, STC-96A PLUS, Applied Biosystems 7500, QuantStudio™ 5, Roche LightCycler®480, Bio-Rad CFX96™, QIAGEN Rotor-Gene Q, Analytik Jena qTOWER3

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