Test Catalog

Test Id : PLAZO

Plazomicin, Plasma

Useful For
Suggests clinical disorders or settings where the test may be helpful

An aid to achieving the desired plasma concentrations of plazomicin

Method Name
A short description of the method used to perform the test

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Plazomicin, P

Aliases
Lists additional common names for a test, as an aid in searching

Plazomicin

PLAZO

Specimen Type
Describes the specimen type validated for testing

Plasma

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube:

Preferred: Lavender top (K2 EDTA)

Acceptable: Lavender top (K3 EDTA, sodium EDTA), light-blue top (sodium citrate), green top (sodium heparin, lithium heparin)

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Trough specimens are preferred for monitoring concentrations and should be collected immediately before the next scheduled dose.

2. Centrifuge and aliquot plasma into plastic vial within 2 hours of collection.

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Plasma Refrigerated (preferred) 28 days
Ambient 28 days
Frozen 28 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

An aid to achieving the desired plasma concentrations of plazomicin

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Plazomicin is an aminoglycoside engineered to overcome the most prevalent aminoglycoside-modifying enzymes, which are a common aminoglycoside-resistance mechanism. Plazomicin levels are intended to be used by clinicians to support clinical decision-making in guiding appropriate dosage adjustments for patients on plazomicin therapy. The safety and effectiveness of plazomicin treatment in an individual patient should ultimately be based on clinical response.

 

The trough reference range represents plazomicin minimum (trough) concentrations associated with a reduced risk of nephrotoxicity. However, some patients with plasma trough concentrations outside the trough reference range may achieve a satisfactory response.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Complicated urinary tract infections (cUTI):

Trough Reference Range: <3 mcg/mL

(Trough=30 minutes before second dose, and 30 minutes before subsequent doses as appropriate)

Interpretation
Provides information to assist in interpretation of the test results

The plazomicin drug package insert should be consulted for information regarding the utilization of plazomicin concentrations and guidance for therapeutic drug monitoring.

 

For patients with complicated urinary tract infections (cUTI) with creatinine clearance values from 15 mL/min to 89 mL/min, monitoring of plazomicin plasma trough concentrations is recommended to avoid potentially toxic levels. For this subset of patients, it is recommended that the sample for the plazomicin minimum (trough) concentration measurement be collected within approximately 30 minutes before administration of the second dose of plazomicin.

 

Plazomicin dosage should be adjusted to avoid trough levels above 3 mcg/mL. Modeled plazomicin trough concentrations from 377 patients with cUTI in Phase 2 and Phase 3 trials have been determined to range from 0.1 to 3.3 mcg/mL (5-95 percentile range) with a median and geometric mean of 0.8 and 0.7 mcg/mL, respectively. Measured plazomicin trough concentrations by liquid chromatography-tandem mass spectrometry for 274 trough samples in the Phase 3 Study ACHN-490-009 resulted in similar values (0.2 to 5.7 mcg/mL 5-95 percentile range; 1.1 mcg/mL median and geometric mean). For effective treatment, some patients may require plasma levels outside of these ranges. Therefore, the expected ranges are provided as guidelines, and individual patient results should be interpreted with the aid of the dosage adjustment algorithms in the plazomicin drug package insert and in the context of the patient's other clinical signs and symptoms.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

No significant cautionary statements

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. McKinnell JA, Connolly LE, Pushkin R, et al: Improved outcomes with plazomicin (PLZ) compared with colistin (CST) in patients with bloodstream infections (BSI) caused by carbapenem-resistant enterobacteriaceae (CRE): Results from CARE study. Poster 1853 presented at ID Week; October 4-8, 2017. San Diego, CA. Available at https://idsa.confex.com/idsa/2017/webprogram/Paper65272.html

2. Golan Y, Cloutier DJ, Komirenko AS, et al. Improved outcomes at late follow-up (LFU) with plazomicin compared with meropenem in patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP) in the EPIC study. Poster 1859 presented at ID Week; October 4-8, 2017. San Diego, CA. Available at https://idsa.confex.com/idsa/2017/webprogram/Paper64741.html

3. Cloutier D: Plazomicin versus meropenem for complicated urinary tract infection and acute pyelonephritis: diagnosis-specific results from the phase 3 EPIC study. Poster 1855. October 4-8, 2017. San Diego, CA

4. Zhanel GG, Lawson CD, Zelenitsky S, et al: Comparison of the next-generation aminoglycoside plazomicin to gentamicin, tobramycin, and amikacin. Expert Rev Anti Infect Ther 2012;10(4):459-73

5. Begg EJ, Barclay ML, Duffull SB: A suggested approach to once-daily aminoglycodise dosing. Br J Clin Pharmac 1995;39:605-609

Method Description
Describes how the test is performed and provides a method-specific reference

Plazomicin is extracted from plasma samples and the supernatant is analyzed by an in-house developed liquid chromatography-tandem mass spectrometry method.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 day

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80299

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
PLAZO Plazomicin, P 92024-9
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
65855 Plazomicin, P 92024-9

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports