Methods and Advances in the Design, Testing and Development of In Vitro Diagnostic Instruments

Wang, Lei; Xu, Wenchang; Wang, Biao; Si, Xiaonan; Li, Shengyu

doi:10.3390/pr11020403

Cited by 5 publications

(2 citation statements)

References 99 publications

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“…In vitro diagnostics (IVD) technology is an indispensable component of modern medical practice, involving the analysis of human samples such as blood, body fluids, and tissues outside the body to provide critical clinical diagnostic information [ 1 , 2 ]. Molecular diagnostics, immunoassays, and biochemical tests represent the three major domains of IVD, with immunoassays holding a significant market share in China [ 3 , 4 ]. Among these, magnetic particle chemiluminescence immunoassay technology is widely employed in the field of immunoassays due to its advantages of short detection time and high precision [ 5 , 6 , 7 ].…”

Section: Introductionmentioning

confidence: 99%

Immunoassay System Based on the Technology of Time-Resolved Fluorescence Resonance Energy Transfer

Xu,

Zhou,

et al. 2024

Sensors

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To enhance the specificity and sensitivity, cut the cost, and realize joint detection of multiple indicators, an immunoassay system based on the technology of time-resolved fluorescence resonance energy transfer (TR-FRET) was studied. Due to the FRET of the reagent, the donor probe and acceptor probe emitted specific fluorescence to enhance specificity. Long-lifetime specific fluorescence from the acceptor probe was combined with time-resolved technology to enhance sensitivity. A xenon flash lamp and a photomultiplier tube (PMT) were selected as the light source and detector, respectively. A filter-switching mechanism was placed in the light path, so the fluorescence signal from the donor and acceptor was measured alternately. The instrument’s design is given, and some specificI parts are described in detail. Key technical specifications of the instrument and procalcitonin (PCT), C-reactive protein (CRP), and interleukin-6(IL-6) were tested, and the test results were presented subsequently. The CV value of the self-designed counting module is better than 0.01%, and the instrument noises for 620 nm and 665 nm are 41.44 and 10.59, respectively. When set at 37 °C, the temperature bias (B) is 0.06 °C, and the temperature fluctuation is 0.10 °C. The CV and bias are between ±3% and 5%, respectively, when pipetting volumes are between 10 μL and 100 μL. Within the concentration range of 0.01 nM to 10 nM, the luminescence values exhibit linear regression correlation coefficients greater than 0.999. For PCT detection, when the concentration ranges from 0.02 ng/mL to 50 ng/mL, the correlation coefficient of linear fitting exceeds 0.999, and the limit of quantification is 0.096 ng/mL. For CRP and IL-6, the detection concentration ranges from 0 ng/mL to 500 ng/mL and 0 ng/mL to 20 ng/mL, respectively, with limits of quantification of 2.70 ng/mL and 2.82 ng/mL, respectively. The experimental results confirm the feasibility of the technical and instrumental solutions.

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Section: Introductionmentioning

confidence: 99%

Immunoassay System Based on the Technology of Time-Resolved Fluorescence Resonance Energy Transfer

Xu,

Zhou,

et al. 2024

Sensors

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“…The knowledge of their properties and their skillful use became the basis for modern immunochemical techniques. Immunochemical techniques, on the other hand, have revolutionized laboratory diagnostics, which consequently translates into a wide clinical application [ 1 ]. An in vitro pregnancy test is defined as a procedure for determining the presence or absence of pregnancy based on in vitro diagnostic techniques [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

From Cereal Grains to Immunochemistry—What Role Have Antibodies Played in the History of the Home Pregnancy Test

Lis

2023

Antibodies

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Today, the home pregnancy test is the most frequently performed laboratory test for self-diagnosis (home diagnostic test). It is also the first laboratory test that has been adapted for self-use at home. This is probably because women have always wanted to know the answer to the question: “Am I pregnant or not?” and always preferred to know the answer to this question intimately and in a discreet way. The history of the pregnancy test is also an interesting example of how the discovery of antibodies and the development of in vitro diagnostic methods based on the antigen–antibody reaction were important for the development of laboratory and clinical diagnostics. Immunodiagnostic techniques (based on the antigen–antibody reaction) are currently the basis of modern specialist laboratory diagnostics, which is essential in clinical diagnosis. The history of the pregnancy test is an interesting one and dates back to ancient times. A pregnancy test is defined as a procedure intended to reveal the presence or absence of pregnancy. Nowadays, every pregnancy test is based on the detection of human chorionic gonadotropin (hCG) in urine or blood. Human chorionic gonadotropin is secreted by the placenta right after a fertilized egg cell implants in the uterus and can be detected in both the urine and blood of pregnant women. Urine pregnancy tests are convenient for self-use at home. Blood tests are performed in medical laboratories. Specialized laboratory methods not only detect hCG but also determine the concentration of this hormone. However, both of these methods are highly accurate and common. Throughout the ages, many different methods were used to detect pregnancy at the earliest stage. Grain, wine, and various small animals were used as research tools. These were both long-term and often unreliable; most were based on folk beliefs and superstitions. Animal pregnancy tests were the first biological tests used in this field. This was a significant advance in the accurate detection of relatively early pregnancy. Animal tests in modern times are considered cruel and inhumane, no matter how reliable their results can be. Their place is now taken by much more specific, more sensitive, and definitely more ethical immunochemical tests. The pregnancy test and the methods to find out whether a woman is pregnant have gone through massive transformations, from bioassays using plants to bioassays on animals to advanced immunochemical techniques and biosensors. Modern pregnancy tests are not invasive and are very sensitive. Nowadays, it takes only about 3 min to know the answer to the question: “Am I pregnant or not?”. However, it was not always as simple as it is today. This manuscript aims to show the important role played by antibodies in the development of laboratory and clinical diagnostics in the example of the interesting history of the pregnancy test.

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Applications of microfluidics in biosensing

Sekhwama,

Mpofu,

Sivarasu

et al. 2024

Discov Appl Sci

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Microfluidic devices have become a vastly popular technology, particularly because of the advantages they offer over their traditional counterparts. They have such a wide range of uses and can make complex tasks quite efficient. One area of research or work that has benefited greatly from the use of microfluidics is biosensing, where microfluidic chips are integrated into biosensor setups. There are growing numbers of applications of microfluidics in this area as researchers look for efficient ways to tackle disease diagnostics and drug discovery, which are critical in this era of recurring pandemics. In this work, the authors review the integration of microfluidic chips with biosensors, as well as microfluidic applications in biosensing, food security, molecular biology, cell diagnostics, and disease diagnostics, and look at some of the most recent research work in these areas. The work covers a wide range of applications including cellular diagnostics, life science research, agro-food processing, immunological diagnostics, molecular diagnostics, and veterinarian diagnostics. Microfluidics is a field which combines fundamental laws of physics and chemistry to solve miniaturization problems involving fluids at the nanoscale and microscale, and as such, the authors also examine some fundamental mathematical concepts in microfluidics and their applications to biosensing. Microfluidics has relatively new technologies with great potential in terms of applications.

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Methods and Advances in the Design, Testing and Development of In Vitro Diagnostic Instruments

Cited by 5 publications

References 99 publications

Immunoassay System Based on the Technology of Time-Resolved Fluorescence Resonance Energy Transfer

Immunoassay System Based on the Technology of Time-Resolved Fluorescence Resonance Energy Transfer

From Cereal Grains to Immunochemistry—What Role Have Antibodies Played in the History of the Home Pregnancy Test

Applications of microfluidics in biosensing

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