COVID-19 Roundup: Breakthrough Antibody Test, Diabetes Recommendations, FDA Warning

Breakthrough Antibody Test

In the journal Current Protocols, researchers have published detailed instructions for the creation and use of their newly developed serological assay for SARS-CoV-2,

“[W]e provide detailed protocols for expressing the required antigen(s) as well as setting up the [two‐stage serological enzyme‐linked immunosorbent assay] that we have developed…We believe that these protocols will be useful not only for research laboratories around the globe, but also for testing in diagnostic/clinical laboratories,” they wrote.

Recommendations for Management of Diabetes in COVID-19 Patients

An international panel of diabetes and endocrinology experts has developed practical recommendations for the management of diabetes during the COVID-19 pandemic.

“We aim to briefly provide insight into potential mechanistic links between the novel coronavirus infection and diabetes, present practical management recommendations, and elaborate on the differential needs of several patient groups,” they wrote.

The researchers used available data published between April 29, 2009 and April 5, 2020, reviewed guidelines published by the WHO, American Diabetes Association, and the CDC.

The recommendations cover considerations of potential effects of diabetes drugs, maintenance of metabolic and glycemic control, the management of hyperglycemia, and surgical treatment of type 2 diabetes.

“Clinical decision making in the management of diabetes is already complex and in normal circumstances we recommend clinicians follow guidelines for management of people with diabetes. However, the recommendations authored by our group add to the existing guidelines by considering specific points for the management of patients with diabetes and COVID-19 disease or at risk for metabolic disease,” they concluded.

FDA Warns Against Off-Label Use of Antimalarial Drugs

The FDA has issued a drug safety communication detailing known side effects of hydroxychloroquine and chloroquine associated with the their use in treatment of patients with COVID-19.

“These risks, which are in the drug labels for their approved uses, may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat COVID-19,” they wrote.

—Michael Potts

References:
Stadlbauer D, Amanat F, Chromikova V, et al. SARS‐CoV‐2 seroconversion in humans: a detailed protocol for a serological assay, antigen production, and test setup. Published online April 17, 2020. Curr Protoc Microbiol. doi: 10.1002/cpmc.100
Bornstein SR, Rubino F, Khunti K, et al. Practical recommendations for the management of diabetes in patients with COVID-19. Published online April 23, 2020. Lancet Diabetes Endo doi: 10.1016/S2213-8587(20)30152-2
Coronavirus (COVID-19) Update: FDA reiterates importance of close patient supervision for ‘off-label’ use of antimalarial drugs to mitigate known risks, including heart rhythm problems. News release. April 24, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reiterates-importance-close-patient-supervision-label-use