Evaluation of new indigenous “point‑of‑care” ABO and Rh grouping device

Tiwari, Aseem Kumar; Setya, Divya; Aggarwal, Geet; Arora, Dinesh; Dara, Ravi C; Ratan, Ankita; Bhardwaj, Gunjan; Acharya, Devi Prasad

doi:10.4103/jlp.jlp_71_17

Cited by 3 publications

(3 citation statements)

References 6 publications

(6 reference statements)

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“…A negative control test without fusion protein will be important to include during clinical implementation for patients with positive tests, given that rare patients may have IgM autoantibodies causing agglutination. 31 Given the similarities of this test to currently used ABO typing 32 and Monospot assays for EBV antibodies, 33 we ultimately do not see this being a significant barrier. Lastly, the fusion protein stability is unknown, which is important for use in low-resource countries.…”

Section: Discussionmentioning

confidence: 99%

A rapid, point of care red blood cell agglutination assay for detecting antibodies against SARS-CoV-2

Kruse

Huang

Smetana

et al. 2020

Preprint

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The COVID-19 pandemic has brought the world to a halt, with cases observed around the globe causing significant mortality. There is an urgent need for serological tests to detect antibodies against SARS-CoV-2, which could be used to assess the prevalence of infection, as well as ascertain individuals who may be protected from future infection. Current serological tests developed for SARS-CoV-2 rely on traditional technologies such as enzyme-linked immunosorbent assays (ELISA) and lateral flow assays, which may lack scalability to meet the demand of hundreds of millions of antibody tests in the coming year. Herein, we present an alternative method of antibody testing that just depends on one protein reagent being added to patient serum/plasma or whole blood and a short five-minute assay time. A novel fusion protein was designed that binds red blood cells (RBC) via a single-chain variable fragment (scFv) against the H antigen and displays the receptor-binding domain (RBD) of SARS-CoV-2 spike protein on the surface of RBCs. Upon mixing of the fusion protein, RBD-scFv with recovered COVID-19 patient serum and RBCs, we observed agglutination of RBCs, indicating the patient developed antibodies against SARS-CoV-2 RBD. Given that the test uses methods routinely used in hospital clinical labs across the world, we anticipate the test can be rapidly deployed with only the protein reagent required at projected manufacturing cost at U.S. cents per test. We anticipate our agglutination assay may find extensive use in low-resource settings for detecting SARS-CoV-2 antibodies. was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission.

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Section: Discussionmentioning

confidence: 99%

A rapid, point of care red blood cell agglutination assay for detecting antibodies against SARS-CoV-2

Kruse

Huang

Smetana

et al. 2020

Preprint

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“…In conclusion, because one-step molecular diagnosis testing is a rapid and simple operation that does not require highly skilled personnel, it can be used for personalized medicine within hospitals as a point of care test (POCT). [25][26][27] Indeed, its correct operation and quality control specifications can better guarantee the validity of this method when it is performed as a POCT. Furthermore, this technique may be used to detect other genotypes.…”

Section: Discussionmentioning

confidence: 99%

Clinical application and importance of one-step human CYP2C19 genotype detection

et al. 2018

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BackgroundTo directly achieve cytochrome P450 2C19 gene (CYP2C19) classification using one-step real-time fluorescent PCR detection and to verify the capabilities of this method with nucleic acid extracted from whole blood samples.MethodsA human CYP2C19 genotyping kit based on one-step real-time fluorescent PCR detection was used to analyze whole blood or genomic DNA samples. This method was compared with pyrosequencing and another quantitative (q)PCR kit for its accuracy, repeatability, detection range analysis, sensitivity, specificity, and anti-interference analysis.ResultsThe one-step real-time PCR method achieved a 100% accuracy rate compared with pyrosequencing and the other qPCR kit. When detecting different concentrations of known genes, concentrations of each sample ranging from 0.2 to 125 ng/µL could be correctly detected. The genotypes of samples treated with anticoagulants, including EDTA and sodium citrate, and chyle blood samples could be correctly detected.ConclusionThe one-step detection method demonstrated high accuracy and a wide detection range. It also had high levels of repeatability, sensitivity, and specificity for the assessment of genomic DNA test samples.

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“…In medical emergencies requiring quick blood transfusion to save lives following an accident, including in war zones and far-off areas, the blood type must be immediately known. For such situations, there is a need for an in-field point-of-care (POC) fast testing device available for blood group determination independent from highly trained personnel, specialized lab equipment, or advanced sample preparation [ 6 , 7 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

Effective Optical Image Assessment of Cellulose Paper Immunostrips for Blood Typing

Ratajczak

Sklodowska-Jaros

Kalwarczyk

et al. 2022

IJMS

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Novel high-performance biosensing devices, based on a microporous cellulose matrix, have been of great interest due to their high sensitivity, low cost, and simple operation. Herein, we report on the design and testing of portable paper-based immunostrips (IMS) for in-field blood typing in emergencies requiring blood transfusion. Cellulose fibrils of a paper membrane were functionalized with antibodies via supramolecular interactions. The formation of hydrogen bonds between IgM pentamer and cellulose fibers was corroborated using quantum mechanical calculations with a model cellulose chain and a representative amino acid sequence. In the proposed immunostrips, paper with a pore size of 3 µm dia. was used to enable functionalization of its channels with antibody molecules while blocking the red blood cells (RBC) from channel entering. Under the optimized test conditions, all blood types of AB0 and Rh system could be determined by naked eye examination, requiring only a small blood sample (3.5 µL). The durability of IgM immunostrips against storing has been tested. A new method of statistical evaluation of digitized blood agglutination images, compatible with a clinical five-level system, has been proposed. Critical parameters of the agglutination process have been established to enable future development of automatic blood typing with machine vision and digital data processing.

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Evaluation of new indigenous “point‑of‑care” ABO and Rh grouping device

Cited by 3 publications

References 6 publications

A rapid, point of care red blood cell agglutination assay for detecting antibodies against SARS-CoV-2

A rapid, point of care red blood cell agglutination assay for detecting antibodies against SARS-CoV-2

Clinical application and importance of one-step human CYP2C19 genotype detection

Effective Optical Image Assessment of Cellulose Paper Immunostrips for Blood Typing

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