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CDC lowered the testing threshold (to 28 cycles) for the fully vaccinated as more fully vaccinated people test positive

The Centers for Disease Control and Prevention will report only those breakthrough cases resulting in hospitalization or death. The agency also lowered the testing threshold, but only for the fully vaccinated.

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As more reports surface of breakthrough COVID cases, in and outside the U.S., the Centers for Disease Control and Prevention (CDC) today said it will change how breakthrough cases are reported, effective May 14.

According to a statement on the CDC’s website, the agency said to help “maximize the quality of the data collected on cases of greatest clinical and public health importance” it will stop reporting weekly COVID breakthrough infections unless they result in hospitalization or death.

The news followed another change, announced late last month, in how PCR tests should be administered to the fully vaccinated.

Both changes will result in lower overall numbers of reports of breakthrough cases in the U.S.

A breakthrough case is recorded if a person tests positive for SARS-Cov-2 two weeks after receiving the single-dose Johnson & Johnson (J&J) shot or completing the two-dose Moderna or Pfizer vaccination.

Why the changes matter

In April, the CDC issued new guidance to laboratories recommending reducing the RT-PCR CT value to 28 cycles — but only for those fully vaccinated individuals being tested for COVID.

In an RT-PCR test — the gold standard for detecting SARS-CoV-2 — RNA is extracted from the swab collected from the patient. It is then converted into DNA, which is then amplified.

CT, or cycle threshold, is a value that emerges during RT-PCR tests. A CT value refers to the number of cycles needed to amplify viral RNA to reach a detectable level.

According to the Indian Council of Medical Research, a patient is considered positive for COVID if the CT value is below 35. In other words, if the virus is detectable after 35 cycles or earlier, then the patient is considered positive.

Dr. Anthony Fauci recommends a CT value of 35. Globally, the accepted cut-off for CT value for COVID ranges between 35 and 40, depending on instructions from manufacturers of testing equipment.

“If the benchmark were to be lowered to 24 it would mean that CT values in the range 25-34 would not be considered positive,” according to the Indian Council of Medical Research, as reported by The Indian Express. “A benchmark of 35, therefore, means that more patients would be considered positive than we would get if the benchmark were 24.”

In other words, lowering CT threshold parameter may lead to missing infectious persons.

CDC won’t report new breakthrough numbers this week

Because the change in how the CDC will report breakthrough cases is still being implemented and won’t take effect until May 14, the CDC did not report new numbers this week.

According to the latest available numbers, as of April 26, the CDC reported 9,245 people had tested positive for COVID at least two weeks after getting their final COVID vaccination. About 9%, or 835, people required hospitalization and 132 died.

Of the hospitalized patients, 241 were said to be asymptomatic or having an illness not related to COVID, and 20 deaths were reported as asymptomatic or not related to the disease.

The latest numbers are from 46 U.S. states and territories. It’s not clear which four states didn’t submit breakthrough case figures to the CDC.

“These surveillance data are a snapshot and help identify patterns and look for signals among vaccine breakthrough cases,” the CDC said in an April 27 statement. “As CDC and state health departments shift to focus only on investigating vaccine breakthrough cases that result in hospitalization or death, those data will be regularly updated and posted every Friday.”

According to the CDC, actual vaccine breakthrough numbers are likely higher as the surveillance system is passive and relies on voluntary reporting from state health departments and may not be complete. In addition, some breakthrough cases will not be identified due to lack of testing. This is particularly true in instances of asymptomatic or mild illness, CDC added.

The CDC said vaccines are still effective, noting the breakthrough cases represent a small percentage of those who have been vaccinated.

READ more: CDC Changes Rules for Counting Breakthrough Cases, as More Fully Vaccinated People Test Positive

 

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