Arrival of coronavirus testing kits delayed; CDC says they need to be ‘re-manufactured’

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(CDC photo)

The Centers for Disease Control has advised the Guam Department of Public Health that the coronavirus kits that were supposed to be shipped to Guam, and other laboratories worldwide, all need to be re-manufactured.

On February 12 the CDC announced that they had developed the kits and Guam public health was advised that Guam would be among the few laboratories to receive them.

A few days later the CDC announced that some labs had reported that the kits they had received were defective and should be sent back for repair.

Guam was expected to receive its kits by the end of February but Public Health’s Grace Bordallo confirmed that none have arrived yet.

Now the CDC says all the test kits must be re-manufactured.

According to a release from Public Health, the CDC has advised that “rigorous quality control measures have identified assay component issues.”

An assay is an investigative procedure the tests the composition of metal to determine its quality

According to the public health release, the CDC is “re-manufacturing the complete test kits to ensure that laboratories have effective and reliable kits.”

Guam Public Health and the other laboratories that receive the test kits will only be able to begin testing “once the re-manufactured test kits arrive” states the release.

There is no specific time frame for the arrival of the re-manufactured test kits on Guam.

All testing for the coronavirus will continue to be conducted in Atlanta Georgia at the CDC headquarters.

The Guam Public Health Laboratory has relocated from the now closed former public health office in Mangilao and moved to the third floor of the RAN-CARE Building on South Marine Corps Drive in Tamuning.

The laboratory is a bio-safety level two laboratory and has maintained certification under the Clinical Laboratory Improvement Amendments (CLIA) for decades. It continues testing for Dengue stereotyping and Influenza sub-typing, but it can not yet test for the coronavirus.

READ the release from Guam Public Health in FULL below:

COVID-19 Laboratory Testing Update by Guam Public Health Laboratory

The Department of Public Health and Social Services (DPHSS) Guam Public Health Laboratory (GPHL) received an update from the U.S. Centers for Disease Control and Prevention (CDC) that rigorous quality control (QC) measures have identified assay component issues. To address this issue, U.S. CDC is remanufacturing the complete test kits to ensure that laboratories have effective and reliable kits. Therefore, many U.S. state and territorial laboratories, including GPHL, will begin testing locally once the remanufactured test kits arrive on Guam. There is no specific timeframe of its arrival on Guam.

Currently, all testing, initial and confirmatory testing, for COVID-19 continues to be performed at U.S. CDC.

The GPHL is a bio-safety level two laboratory and has maintained certification under the Clinical Laboratory Improvement Amendments (CLIA) for decades. It also holds a certificate from the International Air Transport Association (IATA). The U.S. Centers for Medicare and Medicaid Services (CMS) regulates all laboratory testing performed on humans in the U.S. through CLIA.

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