Quantify Plazomicin Drug Levels with Precision and Accuracy
QMS-Plazomicin-300x195

The first therapeutic drug monitoring (TDM) assay available for quantifying drug levels of plazomicin, a novel antibiotic therapeutic, in patients.

The Thermo Scientific™ QMS™ Plazomicin Immunoassay is a new diagnostic tool intended for the quantitative determination of plazomicin in human K2 EDTA plasma. The results obtained are used to monitor levels of plazomicin and to aid in the treatment of patients undergoing plazomicin therapy. The assay is optimized for use on automated clinical chemistry systems providing a wide dynamic range, rapid turn-around-time, and correlates well with LC-MS/MS.

QMS TDM assays are ready-to-use and designed to provide precise measurement of antibiotic drug concentrations

TDM assays enable physicians to monitor and administer therapeutics on an individual patient basis. By maintaining optimized drug-levels, the effects of under or over dosage may be minimized and patient compliance improved.

Features of QMS Plazomicin Immunoassay

  • Accurate: Correlates greater than 0.975 with LC-MS/MS and provides an average accuracy of 100% across the assay range.
  • Precise: High reproducibility for confidence in results with a total precision less than 7% CV
  • Rapid: Quick turnaround time
  • Convenient: Liquid, ready-to-use format

What is Plazomicin?

Plazomicin is an aminoglycoside that is used to treat certain infections caused by multidrug resistant gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae (CRE) in complicated urinary tract infection (cUTI) patients. The CDC characterizes CRE as "nightmare bacteria" and an immediate public health threat5.

Antimicrobial resistance, a threat to public health

Multidrug resistant bacteria are one of the most important current threats to public health1. Antibiotic resistance in hospital and other patient settings has increased profoundly over the last decade for certain infections according to data from the CDC in the United States2. As a result of antimicrobial resistance, standard treatments, over time, become ineffective, resulting in prolonged illnesses and spread of disease3. In a report issued by the CDC, core actions to address this ongoing threat include: improved use of antibiotics, developing new antibiotics, and diagnostic tests4.

References

  1. Multidrug-Resistant Bacteria in the Community: Trends and Lessons Learned. Infect Dis Clin North Am. 30(2):377-390. (Duin and Paterson 2016)
  2. Antibiotic treatment of infections due to carbapenem-resistant Enterobacteriaceae: systematic evaluation of the available evidence. Antimicrob Agents Chemother. 58(2):654-63. (Falagas ME, et al. 2014)
  3. World Health Organization: Antimicrobial resistance. c2018 Feb 15; http://www.who.int/en/news-room/fact-sheets/detail/antimicrobial-resistance; [accessed 2018 Nov 02]
  4. CDC: Antibiotic/ Antimicrobial Resistance (AR/ AMR). c2018 Sep 10; https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf; [accessed 2018 Nov 02]
  5. CDC: Antibiotic / Antimicrobial Resistance (AR / AMR) c2018 Sep 10; https://www.cdc.gov/drugresistance/biggest_threats.html; [accessed 2018 Nov 02]

The Thermo Scientific Solution
The Thermo Scientific QMS (Quantitative Microsphere System) is a homogeneous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) technology. QMS assays offer liquid, ready-to-use convenience. The technology is ideal for automated systems, providing robust and reliable performance that is not affected by shaking or movement of the reagent on the analyzer, or fluctuations in temperature. In addition, a six-point calibration curve offers increased sensitivity and confidence in results at low sample concentrations.

The QMS Plazomicin immunoassay is based on competition between drug in the sample and drug coated onto a microparticle for antibody binding sites of the plazomicin antibody reagent. The plazomicin-coated microparticle reagent is rapidly agglutinated in the presence of the anti-plazomicin antibody reagent and in the absence of any competing drug in the sample. A concentration-dependent classic agglutination inhibition curve can be obtained with the maximum rate of agglutination at the lowest plazomicin concentration and the lowest agglutination rate at the highest plazomicin concentration.

Why use TDMs? 
Not all drugs require Therapeutic Drug Monitoring (TDM). For instance, maintaining drug concentration within the optimal therapeutic range may not be required in cases where the interval between therapeutic and toxic effects is quite broad, as in the case of beta-lactam antibiotics such as penicillin. However, in other instances, TDM is critically important to achieving maximum efficacy while avoiding toxicity. For example, for aminoglycoside antibiotics, concentrations above what is necessary for bactericidal activity may result in toxicity whereas suboptimal dosage may result in prolonged illness. In such instances, TDM is important from both a cost and health perspective.

 

QMS TDM assays are ready-to-use and designed to provide precise measurement of antibiotic drug concentrations

TDM assays enable physicians to monitor and administer therapeutics on an individual patient basis. By maintaining optimized drug-levels, the effects of under or over dosage may be minimized and patient compliance improved.

Features of QMS Plazomicin Immunoassay

  • Accurate: Correlates greater than 0.975 with LC-MS/MS and provides an average accuracy of 100% across the assay range.
  • Precise: High reproducibility for confidence in results with a total precision less than 7% CV
  • Rapid: Quick turnaround time
  • Convenient: Liquid, ready-to-use format

What is Plazomicin?

Plazomicin is an aminoglycoside that is used to treat certain infections caused by multidrug resistant gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae (CRE) in complicated urinary tract infection (cUTI) patients. The CDC characterizes CRE as "nightmare bacteria" and an immediate public health threat5.

Antimicrobial resistance, a threat to public health

Multidrug resistant bacteria are one of the most important current threats to public health1. Antibiotic resistance in hospital and other patient settings has increased profoundly over the last decade for certain infections according to data from the CDC in the United States2. As a result of antimicrobial resistance, standard treatments, over time, become ineffective, resulting in prolonged illnesses and spread of disease3. In a report issued by the CDC, core actions to address this ongoing threat include: improved use of antibiotics, developing new antibiotics, and diagnostic tests4.

References

  1. Multidrug-Resistant Bacteria in the Community: Trends and Lessons Learned. Infect Dis Clin North Am. 30(2):377-390. (Duin and Paterson 2016)
  2. Antibiotic treatment of infections due to carbapenem-resistant Enterobacteriaceae: systematic evaluation of the available evidence. Antimicrob Agents Chemother. 58(2):654-63. (Falagas ME, et al. 2014)
  3. World Health Organization: Antimicrobial resistance. c2018 Feb 15; http://www.who.int/en/news-room/fact-sheets/detail/antimicrobial-resistance; [accessed 2018 Nov 02]
  4. CDC: Antibiotic/ Antimicrobial Resistance (AR/ AMR). c2018 Sep 10; https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf; [accessed 2018 Nov 02]
  5. CDC: Antibiotic / Antimicrobial Resistance (AR / AMR) c2018 Sep 10; https://www.cdc.gov/drugresistance/biggest_threats.html; [accessed 2018 Nov 02]

The Thermo Scientific Solution
The Thermo Scientific QMS (Quantitative Microsphere System) is a homogeneous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) technology. QMS assays offer liquid, ready-to-use convenience. The technology is ideal for automated systems, providing robust and reliable performance that is not affected by shaking or movement of the reagent on the analyzer, or fluctuations in temperature. In addition, a six-point calibration curve offers increased sensitivity and confidence in results at low sample concentrations.

The QMS Plazomicin immunoassay is based on competition between drug in the sample and drug coated onto a microparticle for antibody binding sites of the plazomicin antibody reagent. The plazomicin-coated microparticle reagent is rapidly agglutinated in the presence of the anti-plazomicin antibody reagent and in the absence of any competing drug in the sample. A concentration-dependent classic agglutination inhibition curve can be obtained with the maximum rate of agglutination at the lowest plazomicin concentration and the lowest agglutination rate at the highest plazomicin concentration.

Why use TDMs? 
Not all drugs require Therapeutic Drug Monitoring (TDM). For instance, maintaining drug concentration within the optimal therapeutic range may not be required in cases where the interval between therapeutic and toxic effects is quite broad, as in the case of beta-lactam antibiotics such as penicillin. However, in other instances, TDM is critically important to achieving maximum efficacy while avoiding toxicity. For example, for aminoglycoside antibiotics, concentrations above what is necessary for bactericidal activity may result in toxicity whereas suboptimal dosage may result in prolonged illness. In such instances, TDM is important from both a cost and health perspective.

 

For Use in the USA Only