False-positive Xpert® Xpress SARS-CoV-2 assay in an emergency room and trauma center: A retrospective chart review study.

OBJECTIVES: To review reports false-positive Xpert results in an emergency room and trauma center. METHODS: Patients' data with false-positive Xpert results from November 2020 to February 2022 at Pusan National University Hospital, Busan, Republic of Korea, were extracted from the electronic medical records. RESULTS: The positive predictive value of Xpert was 40%. Of the 12 patients with false-positive results, 5 (41.7%) were re-positives (such as, patients recovered from coronavirus disease-19 [COVID-19]), and 4 (33.3%) had head or facial trauma. Two out of 4 head or facial trauma cases had documented sample contamination with blood. CONCLUSION: We found a high incidence of false-positive Xpert results among patients who recovered from COVID-19 and those with head or facial injury. Careful history taking for COVID-19 and physical examination of the sample collection site is essential before Xpert analysis.

Three cases of clinically significant inaccurate carboxyhemoglobin measurement.

Background: Clinicians often rely on measurement of carboxyhemoglobin (COHb) to confirm or rule out a diagnosis of carbon monoxide (CO) poisoning. Methods: We report two cases of false negative COHb in patients with CO poisoning and one case of false positive COHb in a patient without CO poisoning. Results: In the first case, a 20-year-old male developed headache, confusion, and near-syncope while operating a gasoline-powered pressure washer in an enclosed space. In the emergency department (ED), his COHb was 1.8%, but this level was disregarded, and he was referred for hyperbaric oxygen. His COHb just before hyperbaric oxygen was 4.1%, and later analysis of his blood collected at ED arrival revealed a COHb of 20.1%. The referral ED blood gas machine calibration and controls were within specification. In the second case, a 45-year-old male presented with several others to the ED with symptoms of CO poisoning after exposure at a conference. All others had elevated COHb levels, but his COHb was 2%. He was discharged but returned shortly with continued symptoms and requested his COHb be repeated. The repeat COHb was 17% (84 minutes after the first). After three hours of oxygen, his COHb was 7%. In the final case, an 83-year-old non-smoking male presented to an ED with breathlessness and tachypnea and was diagnosed with COVID-19 pneumonia. His COHb was 7.1%, but he reported living in an all-electric home. Another adult who lived with him and rode with him to the ED was asymptomatic and had a COHb of 3%. Later, COHb of 1.9% was measured from blood collected at ED arrival, and gas chromatography/mass spectrometry confirmed this result (2%). Conclusions: COHb levels are not always accurate. Clinicians should use clinical judgment to manage their patients, including rejecting laboratory values that do not fit the clinical situation.

Performance of urea-mediated dissociation in reducing false-positive of 2019-nCoV IgM test / 中华检验医学杂志

Objective@#To investigate the interference factors causing false-positive result of novel coronavirus IgM antibody (SARS-CoV-2 IgM) detected by gold immunochromatography assay (GICA) and enzyme-linked immunosorbent assay (ELISA).@*Methods@#A total of 71 serum from different pathogen infections and related chronic diseases patients were collected from the Affiliated Hospital of North Sichuan Medical College from January 25, 2020 to February 15, 2020. GICA and ELISA were used to detect 2019-nCoV IgM in 71 serum, including 5 influenza A virus (Flu A) IgM positive serum, 5 influenza B virus (Flu B) IgM positive serum, 5 Mycoplasma pneumonia (MP) IgM positive serum, 5 Legionella pneumophila (LP) IgM positive serum, 29 rheumatoid factor (RF) IgM positive serum, 5 hypertension patients serum, 5 diabetes mellitus patients serum, 6 human immunodeficiency virus (HIV) infection patients serum and 6 Corona Virus Disease 2019 (COVID-19) patients serum. The interference factors causing false positive results of the two methods were analyzed, and urea dissociation test was employed to dissociate the 2019-nCoV IgM positive serum using the best dissociation concentration. Statistical analyses were performed by SPSS, version 19.0.@*Result@#s 2019-nCoV IgM was positive in 18 cases of middle-high level RF-IgM positive serum and 6 cases of 2019-nCoV-infected serum detected by two methods, and the other 47 serum were negative. When the dissociation concentration of urea was 6 mol/L, 2019-nCoV IgM was negative in 17 cases of middle-high level RF-IgM positive serum and positive in 6 cases of 2019-nCoV-infected serum detected by GICA. When the urea dissociation concentration was 4 mol/L, dissociation time was 10 min and the avidity index<0.46 was set as negative, 2019-nCoV IgM was negative in 15 cases of middle-high level RF-IgM positive serum and positive in 6 cases of 2019-nCoV-infected serum detected by ELISA.@*Conclusion@#The middle-high level of RF-IgM could cause false positive results of SARS-CoV-2 IgM detected by GICA and ELISA, and the urea dissociation test would be helpful for reducing the probability of false-positive results of SARS-CoV-2 IgM test.

Reasons and solutions for 'false positive results' of 2019 Novel Coronavirus-specific antibodies detection / 中华检验医学杂志

Assays of specific immunoglobulin M (IgM) and immunoglobulin G (IgG) have been supplemented in 'diagnosis and treatment guidelines of Novel Coronavirus pneumonia' (7th edition) issued by National Health Commission of the People’s Republic of China as an auxiliary evidence to diagnose Novel Coronavirus pneumonia. However, the false positive results is a major problem in the application of antibody assays. The factors causing the false positive results were analyzed and the ways were discussed to reduce the false positive results. The false positive results of antibody assays can be reduced, but they cannot be fully resolved. Antibody assays are valuable criteria for the diagnosis of suspected cases with negative nucleic acid results only if at least two dynamic tests are used.