COVID-19 Response Efforts: Role of Clinical Laboratories

March 12, 2020 Categories: All News, Featured News

Last Updated September 18, 2020

ACLA members have developed and validated novel COVID-19 tests and continue to scale up testing capacity. Members currently performing diagnostic tests for COVID-19 include Aculabs, Aegis Sciences, Ambry Genetics, ARUP, Biodesix, BioReference Laboratories, Exact Sciences, Inform Diagnostics, LabCorp, Mayo Clinic Laboratories, NeoGenomics Laboratories, Quest Diagnostics and Sonic Healthcare.

Recent Updates

COVID-19 Tests Performed By ACLA Members

Molecular PCR tests performed by ACLA members

DateApproximate Tests PerformedApproximate Total Tests to Date
September 17, 2020338,00041,772,000
September 16, 2020326,00041,434,000
September 15, 2020236,000
41,108,000
September 14, 2020167,00040,872,000
September 13, 2020256,00040,705,000
September 12, 2020311,00040,450,000
September 11, 2020300,00040,139,000
September 10, 2020331,00039,847,000
September 9, 2020242,00039,516,000
September 8, 2020141,00039,274,000
September 7, 2020144,00039,133,000
September 6, 2020235,00038,986,000
September 5, 2020283,00038,751,000
September 4, 2020317,00038,468,000
September 3, 2020331,00038,151,000
September 2, 2020305,00037,820,000
September 1, 2020232,00037,515,000
August 31, 2020177,00037,283,000
August 30, 2020256,00037,106,000
August 29, 2020318,00036,850,000
August 28, 2020334,00036,531,000
August 27, 2020330,00036,191,000
August 26, 2020324,00035,862,000
August 25, 2020246,000
35,538,000
August 24, 2020180,00035,291,000
August 23, 2020244,00035,111,000
August 22, 2020329,00034,867,000
August 21, 2020333,00034,538,000
August 20, 2020369,00034,204,000
August 19, 2020348,00033,835,000
August 18, 2020255,00033,487,000
August 17, 2020206,00033,232,000
August 16, 2020271,00033,026,000
August 15, 2020328,00032,741,000
August 14, 2020364,00032,413,000
August 13, 2020369,00032,049,000
August 12, 2020363,00031,680,000
August 11, 2020301,00031,317,000
August 10, 2020264,00031,016,000
August 9, 2020319,00030,752,000
August 8, 2020373,00030,433,000
August 7, 2020397,00030,059,000
August 6, 2020378,00029,662,000
August 5, 2020388,00029,295,000
August 4, 2020308,00028,907,000
August 3, 2020279,00028,600,000
August 2, 2020345,00028,321,000
August 1, 2020383,00027,971,000
July 31, 2020378,00027,588,000
July 30, 2020408,00027,210,000
July 29, 2020391,00026,802,000
July 28, 2020349,00026,411,000
July 27, 2020320,00026,062,000
July 26, 2020380,00025,742,000
July 25, 2020425,00025,362,000
July 24, 2020419,00024,925,000
July 23, 2020419,00024,506,000
July 22, 2020410,00024,088,000
July 21, 2020368,00023,678,000
July 20, 2020341,00023,309,000
July 19, 2020356,00022,968,000
July 18, 2020378,00022,610,000
July 17, 2020366,00022,233,000
July 16, 2020369,00021,868,000
July 15, 2020390,00021,499,000
July 14, 2020349,00021,109,000
July 13, 2020325,00020,760,000
July 12, 2020323,00020,434,000
July 11, 2020358,00020,111,000
July 10, 2020350,00019,753,000
July 9, 2020355,00019,410,000
July 8, 2020349,00019,055,000
July 7, 2020300,00018,706,000
July 6, 2020274,00018,406,000
July 5, 2020290,00018,133,000
July 4, 2020351,00017,843,000
July 3, 2020362,00017,492,000
July 2, 2020348,00017,131,000
July 1, 2020335,00016,782,000
June 30, 2020307,00016,447,000
June 29, 2020263,00016,140,000
June 28, 2020287,00015,877,000
June 27, 2020319,00015,589,000
June 26, 2020332,00015,270,000
June 25, 2020317,00014,942,000
June 24, 2020308,00014,625,000
June 23, 2020263,00014,317,000
June 22, 2020219,00014,054,000
June 21, 2020234,00013,835,000
June 20, 2020300,00013,601,000
June 19, 2020291,00013,291,000
June 18, 2020295,00013,000,000
June 17, 2020282,00012,706,000
June 16, 2020240,00012,424,000
June 15, 2020207,00012,185,000
June 14, 2020229,00011,978,000
June 13, 2020265,00011,744,000
June 12, 2020262,00011,479,000
June 11, 2020254,00011,217,000
June 10, 2020255,00010,962,000
June 9, 2020204,00010,707,000
June 8, 2020167,00010,503,000
June 7, 2020215,00010,336,000
June 6, 2020229,00010,121,000
June 5, 2020256,0009,892,000
June 4, 2020264,0009,627,000
June 3, 2020245,0009,364,000
June 2, 2020214,0009,199,000
June 1, 2020190,0008,905,000
May 31, 2020215,0008,715,000
May 30, 2020226,0008,500,000
May 29, 2020238,0008,274,000
May 28, 2020218,0008,030,000
May 27, 2020209,0007,812,000
May 26, 2020163,0007,604,000
May 25, 2020179,0007,441,000
May 24, 2020192,0007,262,000
May 23, 2020198,0007,070,000
May 22, 2020200,0006,872,000
May 21, 2020203,0006,672,000
May 20, 2020190,0006,467,000
May 19, 2020165,0006,277,000
May 18, 2020134,0006,112,000
May 17, 2020159,0005,978,000
May 16, 2020179,0005,819,000
May 15, 2020177,0005,640,000
May 14, 2020180,0005,455,000
May 13, 2020163,0005,275,000
May 12, 2020139,0005,112,000
May 11, 202096,0004,972,000
May 10, 2020125,0004,876,000
May 9, 2020142,0004,752,000
May 8, 2020148,000 4,610,000
May 7, 2020145,0004,462,000
May 6, 2020147,0004,316,000
May 5, 2020121,0004,170,000
May 4, 202086,0004,048,000
May 3, 2020105,0003,963,000
May 2, 2020123,0003,858,000
May 1, 2020130,0003,735,000
April 30, 2020125,0003,605,000
April 29, 2020118,0003,480,000
April 28, 202098,0003,362,000
April 27, 202066,4553,264,000
April 26, 202090,0003,197,000
April 25, 2020112,0003,107,000
April 24, 2020115,0002,995,000
April 23, 2020109,0002,880,000
April 22, 2020105,000 2,771,000
April 21, 202083,0002,666,000
April 20, 202056,0002,583,000
April 19, 202068,0002,527,000
April 18, 202088,0002,459,000
April 17, 202091,0002,371,000
April 16, 202085,0002,280,000
April 15, 202076,0002,195,000
April 14, 202063,0002,119,000
April 13, 202043,0002,056,000
April 12, 202075,0002,013,000
April 11, 202091,0001,937,000
April 10, 202097,0001,846,000
April 9, 202095,0001,749,000
April 8, 202099,0001,654,000
April 7, 202075,0001,555,000
April 6, 202072,0001,480,000
April 5, 2020108,0001,408,000
April 4, 2020106,0001,300,000
April 3, 2020101,0001,194,000
April 2, 2020102,0001,093,000
April 1, 202092,000992,000
March 31, 202092,000900,000
March 30, 202075,000807,000
March 29, 202082,000732,000
March 28, 202084,000650,000
March 27, 202080,000565,000
March 26, 202080,000485,000
March 25, 202067,000405,000
March 24, 202057,000338,000
March 23, 202047,000281,000
March 22, 202051,000234,000
March 21, 202054,000183,000
March 20, 202041,000129,000
March 19, 202025,00088,000
March 18, 202020,10063,000
March 17, 202014,30043,000
March 16, 20208,20027,000

*Daily testing totals from May 30 – June 2 have been updated to reflect additional reporting.

Testing Prioritization

ACLA has consistently advocated for clear guidelines around testing to ensure high-risk patients and health care workers are able to access the tests they need, when they need them. Testing guidelines and recommendations must also account for repeat or secondary testing in cases where public health officials may require a second validating test for quarantine status.

Supply Shortages

On Saturday, February 29, the FDA issued new guidance that provided an accelerated path for high-complexity laboratories (including commercial laboratories) to support additional testing capacity in response to the COVID-19 outbreak. Prior to this announcement, ACLA members were already working to develop novel tests for COVID-19.

Since commercial tests first went live during the first week of March, we’ve been working closely with the CDC and other federal agencies to help anticipate any potential supply shortages laboratories may face down the line.

The FDA has recently taken several positive steps to make additional platforms and instruments available to provide accelerated access to diagnostic tests for patients. For example, the March 13 updated guidance expanding eligible swabs was an important step forward, as it allowed commercial laboratories to work with additional suppliers to access necessary specimen collection tools.

We continue to closely monitor the status of certain supplies necessary for commercial labs to expand testing capacity. Any one link in the chain of supply and demand could suddenly cause a bottleneck. We need the continued commitment from HHS and the administration to work with us to maintain the necessary volume of those supplies, so that we can remain proactive in the face of these expected challenges.

Coordination with Public Health Partners, Administration

ACLA is committed to supporting our public health partners and rapid response efforts. We’re working closely with our members—and in close coordination with state and local public health labs, hospitals, the Trump Administration, the CDC and the FDA—to increase overall national capacity.

Commercial laboratories have been in close communication with public health agencies since mid-January as part of our existing memorandum of understanding (MOU) with the CDC, the Association of Public Health Laboratories, and the Council of State and Territorial Epidemiologists. The CDC has been actively utilizing ACLA and the MOU to keep ACLA member laboratories with infectious disease expertise informed on the progression of the current outbreak, the government response, and how our member laboratories can best be prepared to support those efforts.

In any outbreak, Centers for Disease Control and Prevention (CDC) laboratories, supported by state public health laboratories, have primary responsibility for providing guidance to healthcare providers, including criteria for diagnosing patients and determining when diagnostic testing would be appropriate. In recent public health emergencies, including the SARS and Zika outbreaks, commercial laboratories have supported public response and expanded test capacity.

Funding and Reimbursement

Experts agree we need more testing to reopen the economy, but giving labs who are actually performing that testing the support and resources they need hasn’t been met with the same urgency. Labs are making significant investments to meet current demand at a time when they are also experiencing a substantial decline in routine testing volumes as physician visits and non-essential surgeries are postponed. Many labs have made the difficult choice to furlough staff.

As we have said since day one, this crisis demands the full force of the clinical laboratory industry—private, public, academic and hospital laboratories are all in this together, and we need to continue to encourage all labs with the appropriate expertise to support expanded testing.  To meet the nation’s testing needs, all laboratories must have predictable reimbursement and consistent access to all supplies necessary for testing.

For the most up-to-date information on COVID-19, including proper preventative measures, please visit the Centers for Disease Control and Prevention.

ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.

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