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|Utilization Guidelines||This should only be ordered in patients who have rising plasma CMV viral loads after at least 3-4 weeks or more of anti-viral therapy. CMV viral loads commonly rise during the first 2-3 weeks of therapy but this does not indicate resistance unless the patient has had recent exposure to the specific drug.|
|Method||PCR, DNA sequencing|
|Container type||Lavender top|
|Amount to Collect||4 mL blood|
|Sample type||EDTA plasma|
|Preferred volume||2 mL plasma|
|Min. Volume||1.5 mL plasma|
|Processing notes||Separate plasma within 2 hours of collection and transfer to sterile screw-top plastic vial.
Freeze plasma at -20C and ship to China Basin and ViraCor on dry ice.
Order ViraCor test # 5600
Call ViraCor for authorization on anything other than plasma. Sequencing assays are very sensitive to inhibition, and processing of other sample types, including CSF and BAL, may be affected by PCR inhibitors that affect the result.
|Ref Lab Rejection Criteria||CMV DNA concentrations too low to allow antiviral resistance testing (<1000 IU/mL for plasma)|
|Synonyms||CMV; CMV susceptability; CID; CMV resistance; CMV inclusion disease|
|Stability||Room temperature 4 days, refrigerated 1 week, frozen at -20C 1 month|
|Turn around times||Set up Monday - Friday. Turnaround 4-6 days|
|Additional information||Resistance of CMV to antivirals usually requires weeks to months of drug exposure and should not be ordered in the first few weeks of treatment, even if viral copy numbers appear to be rising.
Assaying CMV susceptibility to one or more antivirals phenotypically, by culture, can take several weeks and requires a viable viral isolate. Genotypic testing, i..e.,determining whether the virus has one or more mutations associated with resistance, can be performed in a few days and directly on clinical specimens if sufficient viral copy numbers are present. Two genes, UL97 and UL54, the DNA polymerase, are sequenced to permit determination of resistance to ganciclovir, cidofovir and/or foscarnet.
If a mutation has been detected in either the UL97 or UL54 Gene Targets, the mutation site is indicated. A result of "None Detected" indicates that no mutations were detected for that gene target.
UL97 mutations analyzed that have been confirmed by marker transfer experiments include L405P, M460V,
M460I, M460T, V466G, C518Y, H520Q, 590?593DEL, 591?594DEL, 591?607DEL, C592G, A594E, A594G, A594V,
A594T, A594P, 595?603DEL, L595F, L595S, L595W, 595DEL, E596G, G598S, K599T, 600DEL, 601?603DEL, C603R,
C603W, C607F, C607Y, and A613V. Other mutations analyzed that have been found in resistant clinical isolates include M460L, A590T, 590?600DEL, 590?603DEL, A591D, C592F, 594?601DEL, L595T, E596D, N597I, 597?603DEL, G598V, K599M, 600?601DEL, 601DEL, 601?602DEL, C603Y, and A606D.
UL54 mutations analyzed that have transferred antiviral resistance to recombinant viruses include D301N, N408D, N408K, N408S, N410K, F412C, F412L, F412S, F412V, D413A, D413E, D413N, P488R, N495K, K500N,
L501I, T503I, K513N, K513E, K513R, L516R, I521T, P522A, P522S, 524DEL, V526L, C539G, C539R, D542E, L545S, L545W, T552N, Q578H, Q578L, S585A, D588E, D588N, F595I, T700A, V715M, I726T, E756D, E756K, E756Q, L773V, L776M, V781I, V787L, L802M, K805Q, A809V, V812L, T813S, T821I, P829S, A834P, T838A, G841A, G841S, V946L, L957F, 981?982DEL, and A987G. Other mutations not confirmed by transfer experiments, but associated with antiviral resistance include M393R, M393K, T419M, L501F, D515E, Y(I)722V, H729Y, Y751H,
V787I, and R1052C.
This test was developed and its performance characteristics determined by Viracor?IBT Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. Results should be used in conjunction with clinical findings, and should not form the sole basis for a diagnosis or treatment decision.
|CPT coding||83891 (x15) 83898 (x5) 83904 (x10) 83912 (x1) 83890 (x1) 83909 (x10)|
|Last Updated||3/29/2016 5:40:52 PM|