INTENDED USE

The Alinity m MPXV assay is a real-time polymerase chain reaction (PCR) test intended for the qualitative detection of DNA from monkeypox virus (clade I/II) in human lesion swab specimens (i.e., swabs of acute pustular or vesicular rash) in viral transport media (VTM) from individuals suspected of monkeypox infection by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests.

Results are for the identification of monkeypox virus (clade I/II) DNA, which is generally detectable in human pustular or vesicular lesion specimens during the acute phase of infection. Positive results are indicative of the presence of monkeypox virus (clade I/II) DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.The agent detected may not be the definite cause of disease. Negative results obtained with this device do not preclude monkeypox virus (clade I/II) infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

Laboratories within the United States and its territories are required to report test results to the appropriate public health authorities.

The Alinity m MPXV assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures.

The Alinity m MPXV assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

LIMITATIONS OF THE PROCEDURE

• For use under an Emergency Use Authorization only.
• This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only.
• Use of the Alinity m MPXV assay is limited to personnel who have been trained in the procedures of a molecular diagnostic assay and the Alinity m System.
• Laboratories are required to report all results to the appropriate public health authorities.
• The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the positive controls or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in the package insert.
• Optimal performance of this test requires appropriate specimen collection and handling (refer to the SPECIMEN TYPE, STORAGE, AND PREPARATION FOR ANALYSIS section of the package insert).
• This assay does not detect variola virus (smallpox virus).
• While monkeypox virus clade II is the only member of the Orthopoxvirus genus known to be circulating among humans in the US at this time, a positive result most likely represents the presence of monkeypox virus clade II, although there is a small possibility that this result could represent the presence of monkeypox virus clade I. If clinical concern for such an infection exists, healthcare providers should contact the CDC and their local public health authorities for guidance.
• Performance of the assay has been evaluated using contrived clinical lesion swab specimens. Clinical Performance with natural clinical lesion specimens has not been established.
• The assay is indicated for testing of lesion swab specimens. Performance for other specimen types has not been established.
• Performance of the test has only been established in lesion swabs collected in VTM. Performance of the test has not been evaluated for dry swabs or for lesion swabs collected in other transport media types.
• A specimen with a result of “MPXV Negative” does not preclude monkeypox virus infection and should not be used as the sole basis for treatment or other patient management decisions. Collection of multiple specimens (and specimens collected at different time points) from the same patient may be necessary to detect the virus.
• Detection of monkeypox virus DNA may be affected by sample collection methods (eg, if a specimen is improperly collected, transported, or handled), patient factors (eg, presence, type, and duration of symptoms), and/or stage of infection (eg, if collected too early or too late in the course of illness).
• False-negative results may arise from degradation of the viral DNA during storage and transport of the specimens.
• Interfering substances studies have not been performed for this assay. The assay uses conventional well-established nucleic acid extraction methods used for other similar assays. Interference from common endogenous substances is not anticipated.
• The impacts of specific vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs on the performance of this test have not been evaluated.
• As with any molecular test, mutations within the target regions of Alinity m MPXV assay could affect primer and/or probe binding resulting in failure to detect the presence of virus.
• The clinical performance has not been established with all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of monkeypox virus and their prevalence, which change over time.
• Results should be interpreted by a trained professional in conjunction with the patient’s history and clinical signs and symptoms, and epidemiological risk factors.

FOR IN VITRO DIAGNOSTIC USE UNDER THE FDA EMERGENCY USE AUTHORIZATION

• For use under an Emergency Use Authorization
• This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; use by laboratories certified under CLIA, to perform moderate or high complexity tests.
• 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 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.
• Do not use beyond expiration date.
• For Prescription Use Only.