{"id":200,"date":"2020-05-27T20:16:59","date_gmt":"2020-05-27T19:16:59","guid":{"rendered":"http:\/\/www.testingforall.org\/?p=200"},"modified":"2020-07-15T15:55:42","modified_gmt":"2020-07-15T14:55:42","slug":"a-testing-week-for-covid-19-at-home-testing","status":"publish","type":"post","link":"https:\/\/www.testingforall.org\/a-testing-week-for-covid-19-at-home-testing\/","title":{"rendered":"A testing week for COVID-19 at home testing"},"content":{"rendered":"
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This last week has been a rollercoaster ride for many of us with ambitions of scaling testing for SARS-CoV-2. It has been a rollercoaster ride for those who believe in \u201chome sampling\u201d where a kit is sent to an individual\u2019s home for them to take a sample, which is sent through the postal system to an accredited laboratory to carry out the \u201ctest\u201d.<\/p>\n

Trouble for Superdrug\u2019s \u00a369 test\u00a0<\/strong><\/h4>\n

In the last week there was a much publicised release by Superdrug of a \u00a369 at home kit, that is performed in the accredited\u00a0The Doctors Laboratory<\/a>\u00a0pathology lab. The difficulty arose on Thursday when Abbott, who manufacture the system that the test is performed on, released this\u00a0press release<\/a>\u00a0stating that it is \u201cunable to give any guarantees or make claims for the performance of our test if it is used with finger stick blood,\u201d as typically collected in home sampling kits. The validation work that underpins their product\u2019s FDA Emergency Use Authorisation (EUA) and CE marking was performed using \u201cvenous\u201d blood and blood taken from blood banks, and performed in a clinical setting.<\/p>\n

Abbott does note that \u201cit is the responsibility of the individual laboratory to determine specific specimen stability criteria for their laboratory per their laboratory workflow.\u201d The Doctors Laboratory has performed\u00a0independent verification<\/a>\u00a0of the Abbott product, however, it is unclear whether home sampling was part of the verification protocol.<\/p>\n

This avenue of testing was finally closed today when\u00a0MHRA<\/a>\u00a0requested that all \u201cfinger prick\u201d testing in the UK must stop until this sampling method is validated further.<\/p>\n

Is at home sampling a valid solution?<\/h4>\n

The main point here is that the validation work that the manufacturer performed was done in clinical laboratory environments, and not in homes. In clinical settings blood is typically taken from blood banks, or using \u201cvenous draw,\u201d taking blood from a vein in your elbow. Home testing throws up further complications, such as the need to send the sample through the post where it experiences a range of environmental conditions. We know this can have impact. In the manufacturer\u2019s guidance for the\u00a0Roche Elecsys Anti-SARS-CoV-2<\/a>\u00a0assay it states that samples were stable for 3 days between 15-25\u00b0C and in the\u00a0Abbott SARS-Cov-2 IgG<\/a>\u00a0guidance it states that the maximum sample storage time at 15-30\u00b0C is 2 days.<\/p>\n

This means that the viability of this type of home sampling might be dependent on where you live (and thus the postal system available to you). The US postal system can often take 3+ days end-to-end, but the UK has an often overlooked superskill, in that we do have a very effective national mail carrier in the Royal Mail, that provides one of the most ubiquitous next day collection and delivery services of any country in the world. This is an asset that the UK should fully utilise to widen the envelope of high accuracy testing in order to manage the pandemic going forward.<\/p>\n

The future for home testing<\/h4>\n

Testing for All believes that laboratory testing will remain the highest quality COVID-19 testing for a period of time, while other technologies such as\u00a0lateral flow<\/a>\u00a0and other innovative diagnostics such as\u00a0DNANudge<\/a>\u00a0mature to reach the bar of >99.5% sensitivity and specificity suitable for surveillance use cases where the prevalence of SARS-CoV-2 is low.<\/p>\n

Our current approach to testing<\/h4>\n

At this time Testing for All will continue to perform antibody tests for healthcare workers and employers across the UK using \u201cvenous blood\u201d draw sampling, with tests carried out on the Abbott IgG immunoassay. We will also continue to offer PCR swab based testing specifically for employers who are not able to wait for a slot to become available on the NHS testing service. If you are an employer who needs this service for your employees, please contact us<\/a>.<\/p>\n<\/div>\n<\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

This last week has been a rollercoaster ride for many of us with ambitions of scaling testing for SARS-CoV-2. It has been a rollercoaster ride for those who believe in \u201chome sampling\u201d where a kit is sent to an individual\u2019s home for them to take a sample, which is sent through the postal system to […]<\/p>\n","protected":false},"author":1,"featured_media":302,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[45],"tags":[47,48],"_links":{"self":[{"href":"https:\/\/www.testingforall.org\/wp-json\/wp\/v2\/posts\/200"}],"collection":[{"href":"https:\/\/www.testingforall.org\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.testingforall.org\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.testingforall.org\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.testingforall.org\/wp-json\/wp\/v2\/comments?post=200"}],"version-history":[{"count":5,"href":"https:\/\/www.testingforall.org\/wp-json\/wp\/v2\/posts\/200\/revisions"}],"predecessor-version":[{"id":251,"href":"https:\/\/www.testingforall.org\/wp-json\/wp\/v2\/posts\/200\/revisions\/251"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.testingforall.org\/wp-json\/wp\/v2\/media\/302"}],"wp:attachment":[{"href":"https:\/\/www.testingforall.org\/wp-json\/wp\/v2\/media?parent=200"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.testingforall.org\/wp-json\/wp\/v2\/categories?post=200"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.testingforall.org\/wp-json\/wp\/v2\/tags?post=200"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}