Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device

Katty X Wan; Daniel Potts; Pilar Gonzalez; Ian Smith; Haihong Shi; Olga Kavetska

doi:10.4155/bio-2022-0167

Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device

Katty X Wan
, Daniel Potts
, Pilar Gonzalez
, Ian Smith
, Haihong Shi
, Olga Kavetska

Research output: Contribution to journal › Review article › peer-review

Abstract

Aim: A sensitive and selective method for the determination of nirmatrelvir in dried human blood collected by Tasso-M20 was developed and validated from 20.0 to 20,000 ng/ml. Materials & methods: Nirmatrelvir and its stable-labeled internal standard were isolated from approximately 20 μl of blood dried on one volumetric absorptive pad inside the Tasso-M20 device by extraction with methanol, followed by dilution of the supernatant. The extracts were analyzed by high-performance liquid chromatography coupled with tandem mass spectrometric detection. Results & conclusion: The method was fully validated. Hematocrit levels do not impact assay accuracy. Stabilities to cover sample drying and storage at a variety of conditions were conducted. The validated method was used in multiple clinical studies with excellent performance.

Original language	English
Pages (from-to)	1305-1315
Number of pages	11
Journal	Bioanalysis
Volume	14
Issue number	20
DOIs	https://doi.org/10.4155/bio-2022-0167
Publication status	Published - Oct 2022
Externally published	Yes

Keywords

LC-MS/MS
Tasso-M20
dried blood
nirmatrelvir
sample quality
validation

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10.4155/bio-2022-0167

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@article{04d37921522a41709616a02170bfb2c1,

title = "Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device",

abstract = " Aim: A sensitive and selective method for the determination of nirmatrelvir in dried human blood collected by Tasso-M20 was developed and validated from 20.0 to 20,000 ng/ml. Materials \& methods: Nirmatrelvir and its stable-labeled internal standard were isolated from approximately 20 μl of blood dried on one volumetric absorptive pad inside the Tasso-M20 device by extraction with methanol, followed by dilution of the supernatant. The extracts were analyzed by high-performance liquid chromatography coupled with tandem mass spectrometric detection. Results \& conclusion: The method was fully validated. Hematocrit levels do not impact assay accuracy. Stabilities to cover sample drying and storage at a variety of conditions were conducted. The validated method was used in multiple clinical studies with excellent performance. ",

keywords = "LC-MS/MS, Tasso-M20, dried blood, nirmatrelvir, sample quality, validation",

author = "Wan, \{Katty X\} and Daniel Potts and Pilar Gonzalez and Ian Smith and Haihong Shi and Olga Kavetska",

note = "Publisher Copyright: {\textcopyright} 2022 Newlands Press.",

year = "2022",

month = oct,

doi = "10.4155/bio-2022-0167",

language = "English",

volume = "14",

pages = "1305--1315",

journal = "Bioanalysis",

issn = "1757-6180",

publisher = "Taylor and Francis Ltd.",

number = "20",

}

TY - JOUR

T1 - Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device

AU - Wan, Katty X

AU - Potts, Daniel

AU - Gonzalez, Pilar

AU - Smith, Ian

AU - Shi, Haihong

AU - Kavetska, Olga

PY - 2022/10

Y1 - 2022/10

N2 - Aim: A sensitive and selective method for the determination of nirmatrelvir in dried human blood collected by Tasso-M20 was developed and validated from 20.0 to 20,000 ng/ml. Materials & methods: Nirmatrelvir and its stable-labeled internal standard were isolated from approximately 20 μl of blood dried on one volumetric absorptive pad inside the Tasso-M20 device by extraction with methanol, followed by dilution of the supernatant. The extracts were analyzed by high-performance liquid chromatography coupled with tandem mass spectrometric detection. Results & conclusion: The method was fully validated. Hematocrit levels do not impact assay accuracy. Stabilities to cover sample drying and storage at a variety of conditions were conducted. The validated method was used in multiple clinical studies with excellent performance.

AB - Aim: A sensitive and selective method for the determination of nirmatrelvir in dried human blood collected by Tasso-M20 was developed and validated from 20.0 to 20,000 ng/ml. Materials & methods: Nirmatrelvir and its stable-labeled internal standard were isolated from approximately 20 μl of blood dried on one volumetric absorptive pad inside the Tasso-M20 device by extraction with methanol, followed by dilution of the supernatant. The extracts were analyzed by high-performance liquid chromatography coupled with tandem mass spectrometric detection. Results & conclusion: The method was fully validated. Hematocrit levels do not impact assay accuracy. Stabilities to cover sample drying and storage at a variety of conditions were conducted. The validated method was used in multiple clinical studies with excellent performance.

KW - LC-MS/MS

KW - Tasso-M20

KW - dried blood

KW - nirmatrelvir

KW - sample quality

KW - validation

UR - https://www.scopus.com/pages/publications/85144593372

U2 - 10.4155/bio-2022-0167

DO - 10.4155/bio-2022-0167

M3 - Review article

C2 - 36541270

SN - 1757-6180

VL - 14

SP - 1305

EP - 1315

JO - Bioanalysis

JF - Bioanalysis

IS - 20

ER -

Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device

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Keywords

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