COVID-19 test kit
Kroger Health developed a Covid-19 test home collection kit for safe detection of SARS-CoV-2 (Covid-19) virus infection in patients.
The testing kit allows individuals to collect nasal swab samples at home with the guidance of a healthcare provider through telehealth consulting. Kroger Health’s Covid-19 test home collection kit has been authorised by the Food and Drug Administration under an emergency use authorisation (EUA) in July 2020.
Kroger Health collaborated with Gravity Diagnostics, a CLIA laboratory based in Covington, Kentucky, for processing the Covid-19 samples collected by the kit. Gravity Diagnostics has been granted the FDA’s EUA in June 2020 to process Covid-19 samples.
The company will ramp-up the production of Covid-19 test home collection kits with an aim to process up to 60,000 samples each week by the end of July 2020. The company has performed more than 100,000 tests across 19 states until now.
Initially, the testing kits will be available in Arizona, Colorado, Georgia, Indiana, Kansas, Kentucky, Michigan, Montana, Nevada, New Mexico, Ohio, Tennessee, Utah and Virginia. The kits will be made available to other states of the US in the coming weeks.
Kroger Health’s Covid-19 test home collection kit comprises a kit box measuring 6inx7inx2in, patient ID label with the corresponding barcode, two medium alcohol prep pads, a biohazard bag measuring 6inx9in, absorbent sheet, nasal swab, 3ml transport medium in a tube along with patient instruction and label pack for return shipping.
Test collection kit, along with a prescription, will be issued to a patient. It will be shipped to an individual’s home at no cost within 24 hours if the patient qualifies for the test based on the online assessment performed via Kroger’s website.
The patient will collect the sample and stabilise the viral RNA from the nasal swab sample in the transport medium containing 0.85% saline. A licensed healthcare professional will guide the patients through the collection process at home via a two-way video chat.
Collected samples will be shipped to the laboratories designated by Kroger Health’s parent company The Kroger Co for processing, which will take approximately 24 hours to 48 hours.
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC §263a are eligible to perform high complexity tests utilising a NAAT test for processing nasal swabs as per the usage instructions. They carry out in vitro diagnostic (IVD) molecular tests to detect SARS-CoV-2 RNA.
Test results will be released to the individual’s electronic medical portal or over a phone call if the test results for the active infection are negative. In case of positive results, the healthcare professionals will contact the patient over the phone to recommend further care and treatment.
All results will be shared with the health agencies of the government as per law.
Sample stability studies of the test were executed by Quantigen Biosciences in support with The Gates Foundation and UnitedHealth Group.
Kroger Health conducted the home usability study for collection at home and mailed to Gravity Diagnostics for testing.
A total of 37 patients who registered for the test received the kit, of which 35 patients completed every step in the process. The acceptance responses were studied by acceptance criteria, answers “neutral”, “agree”, and “strongly agree”. The rate of acceptance for each process step was more than 90% in 34 available surveys.
The kit showed the sample stability and usability, as per the standards of the FDA.
Kroger Health started the free drive-thru Covid-19 testing in partnership with the US Department of Health and Human Services and eTrueNorth, a pharmacy-based clinical services network, in more than 12 states in April 2020.
It also launched a pilot site-specific walk-up testing for the associates of the company in Michigan and Colorado.
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