Thursday, December 2, 2021

Labs


Diagnostic Testing

Diagnostic testing is meant to determine present an infection in people and is carried out when an individual has indicators or signs according to COVID-19, or when an individual is asymptomatic however has latest identified or suspected publicity to SARS-CoV-2.

Examples of diagnostic testing embody:

  • Testing individuals who have signs according to COVID-19 and who current to their healthcare supplier
  • Testing folks because of contact tracing efforts
  • Testing individuals who point out that they had been uncovered to somebody with a confirmed or suspected case of COVID-19
  • Testing individuals who attended an occasion the place one other attendee was later confirmed to have COVID-19

Screening Testing

Screening assessments are meant to determine contaminated people who find themselves asymptomatic and wouldn’t have identified, suspected, or reported publicity to SARS-CoV-2. Screening helps to determine unknown circumstances in order that measures could be taken to stop additional transmission.

Examples of screening embody testing:

  • Workers in a office setting
  • College students, college, and workers in a college setting
  • An individual earlier than or after journey
  • At residence by somebody who doesn’t have signs related to COVID-19 and no identified exposures to somebody with COVID-19

Public Well being Surveillance Testing

Public well being surveillance is the continuing, systematic assortment, evaluation, and interpretation of health-related knowledge important to the planning, implementation, and analysis of public well being observe. See CDC’s Introduction to Public Well being Surveillance.

Public well being surveillance testing is meant to watch community- or population-level outbreaks of illness, or to characterize the incidence and prevalence of illness. Surveillance testing is carried out on de-identified specimens, and thus, outcomes should not linked to particular person folks. Public well being surveillance testing outcomes can’t be used for particular person decision-making.

Public well being surveillance testing might pattern a sure proportion of a particular inhabitants to watch for growing or lowering prevalence, or to find out the inhabitants impact from neighborhood interventions corresponding to social distancing. An instance of public well being surveillance testing is when a state public well being division develops a plan to randomly choose and pattern a proportion of all folks in a metropolis on a rolling foundation to evaluate native an infection charges and tendencies.

Regulatory Necessities for Diagnostic, Screening, and Public Well being Surveillance Testing

Any laboratory or testing web site that performs diagnostic or screening testing will need to have a Medical Laboratory Enchancment Amendments (CLIA) certificates and meet all relevant CLIA necessities. For extra info, see the Facilities for Medicare & Medicaid Companies CLIA web siteexterior icon. Assays and take a look at programs used for SARS-CoV-2 diagnostic or screening testing will need to have obtained an Emergency Use Authorization from the U.S. Meals and Drug Administration (FDA) or be provided beneath the insurance policies in FDA’s Coverage for COVID-19 Examsexterior icon.

Assays and take a look at programs used for SARS-CoV-2 public well being surveillance testing don’t want to fulfill FDA and CLIA necessities for diagnostic and screening testing.

Reporting Diagnostic, Screening, and Public Well being Surveillance Testing Outcomes

Each diagnostic and screening testing outcomes could be reported to the folks whose specimens had been examined and/or to their healthcare suppliers.

As well as, laboratories that carry out diagnostic and screening testing should report take a look at outcomes (constructive and unfavorable) to the native, state, tribal, or territory well being division in accordance with Public Legislation 116-136, § 18115(a), the Coronavirus Assist, Reduction, and Financial Safety (CARES) Act. The Division of Well being and Human Companies printed steering on COVID-19 Pandemic Response, Laboratory Knowledge Reporting: CARES Act Part 18115pdf icon that specifies what knowledge, along with take a look at outcomes, laboratories and testing websites ought to gather and electronically report.

Public well being surveillance testing outcomes can’t be reported to the folks whose specimens have been examined and should not reported to their healthcare suppliers. Public well being surveillance testing outcomes – take a look at outcomes which might be de-identified – could be reported in mixture to native, state, tribal, or territory well being departments upon request. Outcomes from testing that’s carried out exterior of a CLIA-certified facility or with out an FDA-authorized take a look at can solely be reported to a well being division if these outcomes are used strictly for public well being functions, and never used for particular person determination making.



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