Quidel Cardiovascular Inc. (QuidelOrtho) recently issued a recall for its Quidel Triage Cardiac Panels, citing a potential risk of false negative troponin results. The company took this measure to address the issue and prioritize patient safety. False negative troponin results could lead to delayed diagnosis or missing a potentially life-threatening myocardial infarction.

The Quidel Triage Cardiac Panel is a rapid, point-of-care fluorescence immunoassay used in conjunction with the Quidel Triage MeterPro. This test is utilized to determine levels of creatine kinase MB (CK-MB), myoglobin and troponin I in EDTA-anticoagulated whole blood or plasma specimens. It plays a crucial role in aiding the rapid diagnosis of myocardial infarction (heart injury) and is frequently used in emergency room settings.

QuidelOrtho took action on May 25, 2023, by issuing an Urgent Product Correction Notification to customers, recalling specific lots of the Quidel Triage Cardiac Panel. This action was prompted by reports of the test providing inaccurate, lower-than-expected troponin levels in samples.

Subsequently, on July 12, 2023, QuidelOrtho issued an updated notification containing additional recommendations for affected customers who had not yet confirmed the availability of alternative testing methods.

The US Food and Drug Administration (FDA) classified the recall as Class I, indicating the most serious level of risk.

QuidelOrtho did not immediately respond to Xtalks’ request for comment.

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The Need for Accurate Detection

Accurate troponin level detection is vital as normal levels are very low and mostly undetectable in standard blood tests. An increase in troponin levels indicates potential damage to the heart, with high troponin levels being indicative of a heart attack or myocardial infarction. Most patients with a heart attack exhibit elevated troponin levels within six hours, and almost all will show raised levels after 12 hours. While troponin levels alone are not sufficient for diagnosing a heart condition, they assist doctors in assessing the extent of heart damage, guiding treatment decisions and determining treatment effectiveness.

The Consequences of Inaccurate Results

False-negative troponin levels pose significant risks, particularly when diagnosing non-ST-segment elevation myocardial infarctions (NSTEMI). They can lead to delayed diagnosis and hinder the timely administration of appropriate treatment to prevent further damage or injury to the heart muscles.

Patients who may have been affected by the Quidel Triage Cardiac Panels recall are encouraged to seek alternative testing options promptly to ensure accurate and timely diagnosis and treatment of any cardiac issues.

FDA Recommendations

The FDA advises all healthcare providers, laboratory personnel and facilities currently using the Quidel Triage Cardiac Panel to immediately discontinue its use. Alternative testing methods should be employed instead. In cases where alternative options are unavailable, patients should be redirected to testing sites equipped with alternative methods.

Physicians facing a lack of alternatives can follow QuidelOrtho’s May 25, 2023, Urgent Product Correction Notification. The recommendation entails flagging and reporting all negative results to clinicians, performing serial sampling and keeping patients under observation until at least three negative troponin values are obtained. Additionally, other factors like clinical presentation, EKG and imaging should be considered. QuidelOrtho has a small stock of unaffected products that can be used as replacements if no other option is available.

Alternative Troponin Test Options

Several alternative troponin test options are available in the market, such as Roche’s Elecsys Troponin T (TnT) Gen 5 Stat blood test, Abbot’s Architect Stat High Sensitivity Troponin-I blood test, Siemens Diagnostics’ HsVista for hs-cTnI and DRG International’s TroponinI rapid test.

Other Quidel Recalls

In addition to the Quidel Triage Cardiac Panels, Quidel also recalled the Lyra SARS-CoV-2 Assay (M120) in July 2021 due to a significant risk of false negative results for patients with relatively high amounts of SARS‐CoV‐2 virus.