Parameter Set Anti-HIV Drugs - LC-MS/MS

Order No.: 92924
Parameters:
Amprenavir, Atazanavir, Darunavir, Efavirenz, Elvitegravir, Etravirine, Indinavir, Lopinavir, Maraviroc, Nelfinavir, Nelfinavir-M8, Raltegravir, Ritonavir, Saquinavir

Encompasses 17 analytes
6PLUS1® Multilevel Calibrator Set available
Part of the MassTox® TDM Series A

CE-IVD validated product ready for IVDR within timeframes and transition periods specified by the IVDR 2017/746

Amprenavir

Atazanavir

Darunavir

Delavirdine

Efavirenz

Elvitegravir

Etravirine

Indinavir

Lopinavir

Maraviroc

Nelfinavir

Nelfinavir-M8

Nevirapine

Raltegravir

Rilpivirine

Ritonavir

Saquinavir

Clinical relevance

According to estimates from UNAIDS there are about 36.9 million people worldwide living with HIV, of which approximately 3 million are children under the age of 15 years. Even if the number of globally registered new infections is decreasing, it was still at approx. 2 million in 2014. The currently available drugs, which are usually prescribed as part of HAART (highly active antiretroviral therapy), interfere with or prevent the development of the virus at different stages of reproduction or cell infection.

Regular monitoring of drug concentration is very important, especially in HIV therapy. Sufficiently high levels of the administered antiretroviral drugs in plasma are a key factor in the success of the treatment. Individual plasma levels can fluctuate significantly and low levels can affect the success of the treatment. On the other hand high concentrations can cause major side effects, such as disorders of the central nervous system, liver toxicity, gastrointestinal disorders or renal toxicity. Therefore the measurement of drug concentrations in serum or plasma is essential for optimising the therapy.

 

Product advantages

With the Parameter Set Anti-HIV Drugs in serum/plasma, 18 different drugs can be measured quickly and efficiently using LC-MS/MS. Due to the careful optimisation of all kit components as well as the chromatographic separation, matrix effects (“ion suppression”) are minimised and the robustness of the method is enhanced. Sample preparation is based on a protein precipitation step. The use of stable isotopically labelled (deuterated) and co-eluting internal standards as well as 6PLUS1® multilevel calibrators ensures high precision and the reproducible and reliable quantification of the analytes. The method is comprehensively validated.

The Parameter Set is a part of the Series A modular system, which enables the analysis of all parameters without switching column or changing the mobile phases, thereby minimising required workload in the laboratory. The Basic Kit A contains all components required for sample preparation and all necessary mobile phases. The MasterColumn® A is the analytical column used for the determination of all Series A analytes. Our portfolio contains further MassTox® Parameter Sets.

For the analysis you require the MassTox® TDM Basic Kit A, the specific MassTox® TDM Parameter Set and the analytical column MassTox® TDM MasterColumn® A.

More Information
Method of Analysis LC-MS/MS
Please note The freely available information on this website, in particular on the sample preparation, are not sufficient to work with our products. Please read instructions and warning notices on products and/or instruction manuals.
Lower Limit of Quantitation 1.0 – 65 µg/l
Upper Limit of Quantification up to 168 mg/l
Intraassay CV= 1.0 – 6.7 %
Interassay CV= 1.5 – 8.1 %
Recovery 88 – 111 %
Specimen Serum/Plasma
Sample Preparation
  • Reconstitute the Internal Standard Mix
  • Add 800 µl Internal Standard Mix to 12 ml Precipitation Reagent (= mixture A).
  • Pipette 50 µl sample/calibrator/MassCheck® control into a 1.5 ml reaction vial.
  • Add 25 µl Extraction Buffer, mix briefly (vortex) and incubate 2 min.
  • Add 250 µl of mixture A, mix 30 s (vortex) and centrifuge 5 min.
  • Dilute supernatant with Dilution Buffer (depending on instrument sensitivity) and inject into LC-MS/MS system.
Run Time 3.0 – 3.5 min
Injection Volume 0.2 – 50 µl
Gradient

Group 1
0.00–0.20 min, 0 % Mobile Phase 2
0.21–2.00 min, 70 % Mobile Phase 2
2.01–2.90 min, 100 % Mobile Phase 2
2.91–3.50 min, 0 % Mobile Phase 2
Group 2
0.00–0.20 min, 0 % Mobile Phase 2
0.21–0.60 min, 50 % Mobile Phase 2
0.61–2.40 min, 90 % Mobile Phase 2
2.41–3.00 min, 0 % Mobile Phase 2
Group 3
0.00–0.20 min, 0 % Mobile Phase 2
0.21–2.30 min, 90 % Mobile Phase 2
2.31–3.10 min, 0 % Mobile Phase 2

Ionisation ESI positive
MS/MS Mode MRM
Additional Info We recommend to set the scan time to a value that allows to achieve a minimum of 10 data points over the whole peak width.
Parameters Amprenavir, Atazanavir, Darunavir, Efavirenz, Elvitegravir, Etravirine, Indinavir, Lopinavir, Maraviroc, Nelfinavir, Nelfinavir-M8, Raltegravir, Ritonavir, Saquinavir
The following components are included in the kit:
The following products are not included in the kit but are required for the application of the method:
As a customer please login or register to gain full access.

Amprenavir

Atazanavir

Darunavir

Delavirdine

Efavirenz

Elvitegravir

Etravirine

Indinavir

Lopinavir

Maraviroc

Nelfinavir

Nelfinavir-M8

Nevirapine

Raltegravir

Rilpivirine

Ritonavir

Saquinavir

Clinical relevance

According to estimates from UNAIDS there are about 36.9 million people worldwide living with HIV, of which approximately 3 million are children under the age of 15 years. Even if the number of globally registered new infections is decreasing, it was still at approx. 2 million in 2014. The currently available drugs, which are usually prescribed as part of HAART (highly active antiretroviral therapy), interfere with or prevent the development of the virus at different stages of reproduction or cell infection.

Regular monitoring of drug concentration is very important, especially in HIV therapy. Sufficiently high levels of the administered antiretroviral drugs in plasma are a key factor in the success of the treatment. Individual plasma levels can fluctuate significantly and low levels can affect the success of the treatment. On the other hand high concentrations can cause major side effects, such as disorders of the central nervous system, liver toxicity, gastrointestinal disorders or renal toxicity. Therefore the measurement of drug concentrations in serum or plasma is essential for optimising the therapy.

 

Product advantages

With the Parameter Set Anti-HIV Drugs in serum/plasma, 18 different drugs can be measured quickly and efficiently using LC-MS/MS. Due to the careful optimisation of all kit components as well as the chromatographic separation, matrix effects (“ion suppression”) are minimised and the robustness of the method is enhanced. Sample preparation is based on a protein precipitation step. The use of stable isotopically labelled (deuterated) and co-eluting internal standards as well as 6PLUS1® multilevel calibrators ensures high precision and the reproducible and reliable quantification of the analytes. The method is comprehensively validated.

The Parameter Set is a part of the Series A modular system, which enables the analysis of all parameters without switching column or changing the mobile phases, thereby minimising required workload in the laboratory. The Basic Kit A contains all components required for sample preparation and all necessary mobile phases. The MasterColumn® A is the analytical column used for the determination of all Series A analytes. Our portfolio contains further MassTox® Parameter Sets.

For the analysis you require the MassTox® TDM Basic Kit A, the specific MassTox® TDM Parameter Set and the analytical column MassTox® TDM MasterColumn® A.

More Information
Method of Analysis LC-MS/MS
Please note The freely available information on this website, in particular on the sample preparation, are not sufficient to work with our products. Please read instructions and warning notices on products and/or instruction manuals.
Lower Limit of Quantitation 1.0 – 65 µg/l
Upper Limit of Quantification up to 168 mg/l
Intraassay CV= 1.0 – 6.7 %
Interassay CV= 1.5 – 8.1 %
Recovery 88 – 111 %
Specimen Serum/Plasma
Sample Preparation
  • Reconstitute the Internal Standard Mix
  • Add 800 µl Internal Standard Mix to 12 ml Precipitation Reagent (= mixture A).
  • Pipette 50 µl sample/calibrator/MassCheck® control into a 1.5 ml reaction vial.
  • Add 25 µl Extraction Buffer, mix briefly (vortex) and incubate 2 min.
  • Add 250 µl of mixture A, mix 30 s (vortex) and centrifuge 5 min.
  • Dilute supernatant with Dilution Buffer (depending on instrument sensitivity) and inject into LC-MS/MS system.
Run Time 3.0 – 3.5 min
Injection Volume 0.2 – 50 µl
Gradient

Group 1
0.00–0.20 min, 0 % Mobile Phase 2
0.21–2.00 min, 70 % Mobile Phase 2
2.01–2.90 min, 100 % Mobile Phase 2
2.91–3.50 min, 0 % Mobile Phase 2
Group 2
0.00–0.20 min, 0 % Mobile Phase 2
0.21–0.60 min, 50 % Mobile Phase 2
0.61–2.40 min, 90 % Mobile Phase 2
2.41–3.00 min, 0 % Mobile Phase 2
Group 3
0.00–0.20 min, 0 % Mobile Phase 2
0.21–2.30 min, 90 % Mobile Phase 2
2.31–3.10 min, 0 % Mobile Phase 2

Ionisation ESI positive
MS/MS Mode MRM
Additional Info We recommend to set the scan time to a value that allows to achieve a minimum of 10 data points over the whole peak width.
Parameters Amprenavir, Atazanavir, Darunavir, Efavirenz, Elvitegravir, Etravirine, Indinavir, Lopinavir, Maraviroc, Nelfinavir, Nelfinavir-M8, Raltegravir, Ritonavir, Saquinavir
The following components are included in the kit:
The following products are not included in the kit but are required for the application of the method:
As a customer please login or register to gain full access.