Assembling the kit against COVID-19

A number of companies have been reporting new tools and services to join in the fight against COVID-19 recently, among them Agilent, which has released an ELISA kit for detecting SARS-CoV-2 antibodies. BioIVT has advertised a COVID-19 panel intended to help accelerate research into vaccine-generated immune response, and from Zymo Research comes a COVID-19 sequencing service for detecting variants. SeqOnce Biosciences has also announced an RT-qPCR assay for detecting the N501Y (UK) variant. 

Read on to learn more about some of the latest additions to the COVID-19 toolkit.

Agilent releases SARS-CoV-2 immunoassay kit

SANTA CLARA, Calif.—Agilent Technologies Inc. has launched a SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) kit, intended for the qualitative detection of immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum or plasma. The kit has been submitted to the FDA for Emergency Use Authorization. The company also plans to register the assay in other markets in 2021, including Canada, Europe, and selected Asia Pacific and Latin American countries. 

The kit is a qualitative two-step indirect ELISA for the detection of human IgG antibodies to the SARS-CoV-2 S1 receptor-binding domain protein. It will aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Agilent reports that its clinical study data points to a highly accurate immunoassay, with 98.9-percent sensitivity and 98.8-percent specificity. 

“Implementing new technologies into clinical workflows can be daunting, and the pressures of the SARS-CoV-2 pandemic have further exacerbated the need for technology solutions that are quick and easy to implement,” said Sam Raha, president of the Diagnostics and Genomics Group at Agilent. “Providing turnkey solutions eases the implementation and validation resources for clinical labs, which helps lower the barrier to the adoption of additional SARS-CoV-2 tests.” 

The ELISA kit includes consumables and contains all necessary reagents—including negative, positive, and cutoff controls. The ready-to-use solution is said to consistently execute dependable SARS-CoV-2 serological testing. 

BioIVT unveils COVID-19 vaccination panel

WESTBURY, NY—BioIVT has introduced a COVID-19 vaccination panel—composed of pre- and post-vaccination serum or PBMC samples—meant to enable researchers to study blood donors’ vaccine-generated immune response.

BioIVT has been providing biospecimens to support the development of COVID-19 diagnostic assays and therapeutic interventions since the pandemic began. Those biospecimens have included saliva, serum, plasma, PBMCs, fresh whole blood, bulk plasma, and bulk serum from acute COVID-19 cases and recovered donors—together with representative diagnostic polymerase chain reaction or serological antibody test results to verify infection and /or exposure. BioIVT samples are provided with donor social, demographic, and co-morbidity data together with the date of onset, symptoms, and severity of their COVID-19 infection where available. 

“Building on that experience, BioIVT is introducing this longitudinal collection to support clients investigating immune responses to the COVID-19 vaccines. As the global rollout of COVID-19 vaccines continues, BioIVT is helping to maximize the clinical data collected and increase scientific knowledge of vaccine efficacy in different donor populations,” reported Dr. Cathie G. Miller, senior director of marketing and personalized medicine at BioIVT. “We already have donors enrolled and initial samples processed, and we will continue to expand this inventory.”

BioIVT’s COVID-19 vaccination panel features samples collected from donors at three times: pre-COVID-19 vaccination, over 14 days after the first vaccine administration but before the second, as well as more than 14 days after the second vaccine is administered. While serum and isolated PBMCs will be the main biospecimens processed, other additional biospecimens from confirmed COVID-19 vaccinated donors will be available for specific client needs.

Zymo offers COVID-19 variant sequencing

IRVINE, Calif.—Zymo Research has announced its new, global COVID-19 Variant Sequencing Service. The end-to-end service includes the necessary collection devices and automated extraction technology, with RNA sequencing completed on Illumina platforms. The company’s DNA/RNA Shield is used for the collection, transportation, and preservation of the samples. The preservative inactivates the SARS-CoV-2 virus while stabilizing its RNA, which allows for room-temperature transport.

The COVID-19 Variant Sequencing Service workflow consists of sample collection, processing, sequencing, and reporting. COVID-positive samples are collected from test centers and transported to Zymo Research and its affiliates for processing. The samples are processed with automated RNA extraction via KingFisher Flex robotics platform, sequenced with Illumina sequencing-by-synthesis technology, and then analyzed using the hardware-accelerated DRAGEN COVIDSeq Analysis Pipeline. The final report will include COVID-19 strain identification, genome sequencing coverage, confirmed mutations, consensus genome, and raw sequence files.

SeqOnce showcases assay to detect N501Y variant

PASADENA, Calif.—SeqOnce Biosciences Inc. recently sent into the market its new AzureSeq One-Step Universal RT-qPCR kit for the detection of the N501Y variant of SARS-CoV-2. 

“The AzureSeq N501Y assay provides health officials, CLIA labs, and hospitals the ability to quickly identify and monitor this important SARS-CoV-2 variant. We decided to also target the N1 gene so the assay can be used in front-line detection, as well as identification of samples that have previously tested positive,” stated Joe Dunham, chief scientific officer of SeqOnce.

The AzureSeq One-Step Universal SARS-CoV-2 RT-qPCR N501Y kit uses a single-tube reaction targeting the N1 nucleocapsid gene, both alleles of S gene N501Y (A23063T), and includes RNaseP as a control. The assay uses common qPCR instruments with detection channels of FAM, HEX, Cy5, and ROX, and does not require viral RNA extraction. It has a rapid cycling protocol option, delivering sample to answer results in around an hour. The kit is currently intended solely for research use.