scholarly journals False Covid-19 Test Results – Could We Do Things Better? A Personal Opinion

Author(s):  
Suzanne Lisbeth Ekelund

This paper describes the problems with false covid-19 test results, both false positive and false negative results. The problems are related to the quality of tests, test sampling and the currently limited follow-up procedures. A test and follow-up strategy that could decrease the potential problems is suggested.

2003 ◽  
Vol 10 (5) ◽  
pp. 802-807 ◽  
Author(s):  
Andréia R. Neves ◽  
Ronei L. Mamoni ◽  
Cláudio L. Rossi ◽  
Zoilo P. de Camargo ◽  
Maria Heloísa S. L. Blotta

ABSTRACT Immunodiffusion (ID) is the serologic test most frequently used for the diagnosis and posttherapy follow-up of patients with paracoccidioidomycosis (PCM). The ID test is highly specific (100%), but its sensitivity is relatively low (90%), leading to false-negative results. The aim of this study was to determine the profiles of antibodies in sera from patients with proven PCM and with negative results in the ID test (IDneg) versus positive results in the ID test (IDpos). We analyzed 46 sera from patients with active PCM for total immunoglobulin G (IgG) and IgG subclass responses to Paracoccidioides brasiliensis gp43 antigen (treated or not treated with sodium metaperiodate) by enzyme-linked immunosorbent assay and immunoblotting. Immunoblotting showed that both IDneg and IDpos sera recognized predominantly the gp43 fraction of the P. brasiliensis antigen used in the ID test. IDneg sera contain low-avidity antibodies, low levels of specific IgG (total) and IgG1, and high levels of IgG2 compared with IDpos sera. The antibodies present in IDneg sera were predominantly directed against carbohydrate epitopes, since treatment with sodium metaperiodate resulted in a significant decrease in antibody reactivity. These data suggest that the lack of reactivity of sera from PCM patients in the ID test may be related to the production of low-avidity IgG2 antibodies directed against carbohydrate epitopes.


Author(s):  
Shirin Hakimi

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has spread rapidly and developed the current pandemic and the stressful lifestyle in addition with extreme pressure on people was the consequence of its increasing mortality rate. Since COVID-19 is highly infectious, it is crucial to diagnose the disease timely and initiate preventive measures to control the epidemic. Therefore, the need for accurate detection of this virus has been increased dramatically. Real-Time reverse-transcription Polymerase Chain Reaction (RT-PCR) tests are considered a gold standard to detect SARS-CoV-2 RNA. Besides, the recent pandemic has posed the most serious challenge in PCR applications to date. Although RT-PCR has great accuracy, some factors can reduce the efficiency of this test. Time of testing and type of sample are typical elements that may cause false negative results. Furthermore, false positive cases would be the result of contamination and unoptimized primers. In this paper, the relevant factors creating false positive and false negative results have been investigated in depth to increase the awareness of clinicians.


1974 ◽  
Vol 31 (02) ◽  
pp. 273-278
Author(s):  
Kenneth K Wu ◽  
John C Hoak ◽  
Robert W Barnes ◽  
Stuart L Frankel

SummaryIn order to evaluate its daily variability and reliability, impedance phlebography was performed daily or on alternate days on 61 patients with deep vein thrombosis, of whom 47 also had 125I-fibrinogen uptake tests and 22 had radiographic venography. The results showed that impedance phlebography was highly variable and poorly reliable. False positive results were noted in 8 limbs (18%) and false negative results in 3 limbs (7%). Despite its being simple, rapid and noninvasive, its clinical usefulness is doubtful when performed according to the original method.


2020 ◽  
Vol 13 (1) ◽  
pp. 413-414 ◽  
Author(s):  
Mohamed Farouk Allam

Due to the international spread of COVID-19, the difficulty of collecting nasopharyngeal swab specimen from all suspected patients, the costs of RT-PCR and CT, and the false negative results of RT-PCR assay in 41% of COVID-19 patients, a scoring system is needed to classify the suspected patients in order to determine the need for follow-up, home isolation, quarantine or the conduction of further investigations. A scoring system is proposed as a diagnostic tool for suspected patients. It includes Epidemiological Evidence of Exposure, Clinical Symptoms and Signs, and Investigations (if available). This scoring system is simple, could be calculated in a few minutes, and incorporates the main possible data/findings of any patient.


PEDIATRICS ◽  
1996 ◽  
Vol 98 (1) ◽  
pp. 41-44
Author(s):  
Judy G. Saslow ◽  
Ernest M. Post ◽  
Carol A. Southard

Objective. As neonatal discharge before 24 hours of life becomes commonplace, the rejection of congenital hypothyroidism (CH) screening specimens obtained too early has created the need for numerous additional tests. We sought to determine whether the specimens obtained before 24 hours could be used safely. Methods. During a 31-day period we measured thyrotropin in all thyroid-screening specimens that had been obtained before 24 hours. We also examined the early specimens from every infant diagnosed in New Jersey with CH during 1993 or 1994. Results. Among the 663 specimens, those obtained at or before 12 hours and those from infants with birth weights less than 2500 g had too many low thyroxine results to be useful. Among the 515 specimens obtained at more than 12 to 24 hours from newborns weighing 2500 g or more, 37 (7%) had low thyroxine levels and 12 (2.3%) had thyrotropin levels of 20 µIU/mL (mU/L) or higher. Four hundred seventy-one of the 515 infants had subsequent specimens obtained at more than 24 hours, and none of the results were abnormal. There was no child weighing more than or equal to 2500 g who was diagnosed with CH in 1993 and 1994 whose specimen obtained at 24 hours or less was normal. Conclusions. Accepting specimens obtained at more than 12 to 24 hours from infants weighing 2500 g or more would have resulted in more than the usual number of false-positive results but no false-negative results. This would have decreased the requests for additional specimens by more than 90%.


2019 ◽  
Vol 5 (2) ◽  
pp. 290-299
Author(s):  
Isabelle Danielle Piec ◽  
Beatrice Tompkins ◽  
William Duncan Fraser

Abstract Background Asfotase alfa (STRENSIQ®, Alexion Pharmaceuticals, Inc.) is the only approved treatment for patients with pediatric-onset hypophosphatasia, a disease caused by a mutation in the tissue-nonspecific alkaline phosphatase (TNSALP) gene. ALP is often used as signaling system in routine immunoassays. Because asfotase alfa contains the active site of the full ALP enzyme, it can catalyze the substrate as the antibody-conjugated ALP would within an assay. Therefore, its presence in a treated patient’s sample may generate false positive or false negative results. We investigated whether the presence of asfotase alfa within a sample induced interference in immunoassays that utilize ALP or alternative detection systems. Methods Asfotase alfa was added to samples at concentrations from 0.08–5 µg/mL and analysed on various immunoassays following manufacturer’s instructions. Results Asfotase alfa was detected in all ALP assays but ALKP1 (RayBiotech). We observed no changes in normetanephrine and noradrenaline (IBL) at any asfotase alfa concentration. However, asfotase alfa notably interfered in an oxytocin (ENZO) assay in nonextracted samples. Extraction using a C18 column eliminated the interference. No interference was observed on automated analyzers using alternative detection system (COBAS fT4 and TSH; Advia Centaur FSH, fT4; Architect LH; FSH). Immulite 2000 fT4, TSH, testosterone and hCG (ALP-based) showed no interference. However, the presence of asfotase alfa resulted in a dose-dependent increase of Troponin I signal. Conclusion The presence of asfotase alfa must be taken into consideration when analyzing blood samples in treated patients to avoid any risk of misinterpretation of false positive/negative results. It is essential that assays be tested for this possible interference.


2019 ◽  
Vol 152 (Supplement_1) ◽  
pp. S147-S147
Author(s):  
Andrew Hall ◽  
Ortega Lopez ◽  
Amy Powers

Abstract Introduction Testing for thrombophilic risk factors is common in patients with thrombosis. However, inpatient hereditary thrombophilia work-ups are prone to false-positive and false-negative results due to concurrent acute phase changes, protein consumption, anticoagulation therapy, and liver disease. A recent ASCP Choosing Wisely guideline recommends against measuring protein C (PC), protein S (PS), or antithrombin III (AT3) to diagnose a hereditary deficiency during an active clotting event. We aimed to review inpatient PC, PS, and AT3 activity assay ordering practices at a tertiary care center. The goal of this study was to determine appropriateness and identify areas for improvement in inpatient thrombophilia ordering practices. Methods A retrospective review of inpatients who underwent thrombophilia testing was performed. Inclusion criteria consisted of adult inpatients with PC, PS, and/or AT3 activity results. Patients for whom AT3 was ordered alone were excluded. The timeframe of testing relative to an acute thrombotic event, anticoagulation therapy, and liver disease was determined via electronic medical record review. Other conditions that can affect PC, PS, or AT3 levels were recorded if noted. Results Over 5 months, 50 inpatients underwent testing for PC, PS, and/or AT3. Testing was performed within 2 weeks of an acute thrombotic event in 92% of patients; 32% received anticoagulation therapy prior to testing and 16% had liver disease. Test results below the reference range were found in the following percentage of patients: 16% PC, 34% PS, and 16% AT3. In total, 23 of 50 (46%) patients had one or more abnormal results; all 23 had potential confounding conditions/drug. Conclusions Inpatient PC, PS, and AT3 testing was frequently performed in clinical settings, which may cause false-positive or false-negative results. This demonstrates the need for increased education and dialogue between the laboratory and clinicians to improve test utilization practices. Potential interventions are currently being analyzed.


1994 ◽  
Vol 56 (1-4) ◽  
pp. 291-292 ◽  
Author(s):  
K.D. Cliff ◽  
J.C.H. Miles ◽  
S.P. Naismith

Abstract Data from the UK national survey of radon in 2300 homes has been re-analysed to determine the uncertainty in seasonal correction factors applied to measurements of less than l year. The required correction factor for each six-month result was calculated from the known annual average for the appropriate home. The seasonal correction factors derived for each month were found to be approximately log-normally distributed, with an average geometric standard deviation of 1.36. Following this initial survey, radon measurements have been made in more than 80,000 homes in southwest England to determine whether they are above the UK radon Action level of 200 Bq.m-3. The measurements were carried out over three months in each case using etched track detectors in two locations in each home, and the results were corrected for the average seasonal variation found in the original UK study of radon in homes. Because of the uncertainty in the seasonal correction factors, households with between 130 and 300 Bq.m-3 were advised to have a second three-month measurement in a different season before deciding whether or not to take remedial action. More than 7000 homes were remonitored for this purpose. The results are analysed to show the number of false positive and false negative results that would have been reported if advice had been based solely on the initial measurement. It is shown that the present scheme results in extremely small numbers of false positive and false negative results.


1997 ◽  
Vol 12 (Suppl_2) ◽  
pp. 312-312
Author(s):  
L. Míguez ◽  
C. Fuster ◽  
M.M. Perez ◽  
M.L. Alegre ◽  
M. Sostoa ◽  
...  

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