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COVID-19 Molecular Testing
Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome—the individual’s genetic code and how their cells express their genes as proteins—by applying molecular biology to medical testing. The technique is used to diagnose and monitor disease, detect risk, and decide which therapies will work best for individual patients.
As the primary clinical manifestation of COVID-19 is a respiratory illness, PCR tests are generally used to test samples obtained from the upper or lower respiratory tract. Appropriate upper respiratory sample types include a nasopharyngeal swab or a throat swab.
Currently there are two types of diagnostic tests— molecular tests, such as RT-PCR tests, that detect the virus’s genetic material, and antigen tests that detect specific proteins from the virus.
From Mid-March, Labs Saw Big Drop in Revenue
By Joseph Burns | From the Volume XXVII No. 6 – April 20, 2020 Issue
CEO SUMMARY: In response to the coronavirus outbreak, patients stopped seeing their doctors for routine care and hospitals ceased doing elective services. With fewer test referrals, clinical labs and pathology groups were hit with a substantial decline in revenue. One of t…
Italy’s SARS-CoV-2 Outbreak Brings Out Best in Clinical Labs
By Joseph Burns | From the Volume XXVII No. 6 – April 20, 2020 Issue
CEO SUMMARY: Italy was one of the first countries outside of China to experience an explosive outbreak of COVID-19 and its northern provinces were hit hardest by this novel coronavirus. In this exclusive interview with THE DARK REPORT,…
Chicago Lab Launches LDT, Finds 20% Positive
By Joseph Burns | From the Volume XXVII No. 6 – April 20, 2020 Issue
CEO SUMMARY: After seeing the novel coronavirus spread quickly in China, staff in the Department of Pathology and Laboratory Medicine developed a test to identify the pathogen in patients in Chicago and its suburbs. With the CDC’s assay in hand, it started work on its ow…
Labs in Italy Moved Fast to Develop COVID-19 Tests
By Robert Michel | From the Volume XXVII No. 5 – March 30, 2020 Issue
Part One in a Series ITALY HAS ONE OF THE WORLD’S SEVEREST OUTBREAKS OF COVID-19 INFECTIONS, based on the number of cases and the mortality rate. In response, clinical laboratories there moved quickly to launch laboratory-developed tests and to increase the volume of COVID-19…
Northwell Lab Team Validates COVID-19 Test on Fast Timeline
By Joseph Burns | From the Volume XXVII No. 4 – March 9, 2020 Issue
CEO SUMMARY: Clinical labs are working with haste to test for the novel coronavirus, also called nCoV and SARS-CoV-2. Their efforts to prepare for high capacity testing for viral respiratory illness include validating molecular tests for the newly-identifie…
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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