Comparative Clinical Evaluation of the Roche Elecsys and Abbott Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Serology Assays for Coronavirus Disease 2019 (COVID-19)

Context.— The use of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic tests detects antibodies in the host, contributing to the identification of individuals who have been exposed to coronavirus disease 2019 (COVID-19). Objective.— To critically evaluate 2 commercially available SARS-CoV-2 serology tests. Design.— A total of 333 unique, nonduplicated serum samples obtained from COVID-19 patients (n = 170) and negative controls (n = 163) obtained before December 2019 were used in the study. Samples were tested on the Roche E411 and Abbott Architect i4000SR platforms, and results were correlated to reverse transcription polymerase chain reaction (PCR) results and clinical symptoms. Results.— There was a strong level of agreement in the qualitative results between both assays, with a Cohen κ value of .840, P < .001. The specificity for both Roche and Abbott were excellent at 100%. Roche exhibited marginally better performance in the 21 days or more group with a sensitivity of 90.6% (95% CI, 75.8%–96.8%) versus an Abbott sensitivity of 84.4% (95% CI, 68.3%–93.1%), as well as in the 14- to 20-day group with a sensitivity of 85.7% (95% CI, 65.4%–95.0%) versus an Abbott sensitivity of 81.0% (95% CI, 60.0%–92.3%). Less than 14 days of symptoms groups exhibited poor sensitivity at less than 50% for both assays. The areas under curve (± standard error) for Roche (0.894 ± 0.025, P < .001) and Abbott (0.884 ± 0.026, P < .001) were very similar. Potential confounders for negative serologic results include antiretroviral medication use and pauci-symptomatic patients. Conclusions.— Specificities for high-throughput Roche and Abbott immunoassays are excellent, but users need to be cautious to interpret serologic test results after 14 days of symptoms to avoid false negatives.

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Pediatric reference interval verification for endocrine and fertility hormone assays on the Abbott Alinity system

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2021-0337 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Mary Kathryn Bohn ◽

Siobhan Wilson ◽

Alexandra Hall ◽

Khosrow Adeli

Keyword(s):

Clinical Decision Making ◽

De Novo ◽

Reference Interval ◽

Clinical Decision ◽

Reference Intervals ◽

Healthy Children ◽

Confidence Limits ◽

Test Results ◽

Serum Samples ◽

Abbott Architect

Abstract Objectives The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has developed an extensive database of reference intervals (RIs) for several biomarkers on various analytical systems. In this study, pediatric RIs were verified for key immunoassays on the Abbott Alinity system based on the analysis of healthy children samples and comparison to comprehensive RIs previously established for Abbott ARCHITECT assays. Methods Analytical performance of Alinity immunoassays was first assessed. Subsequently, 100 serum samples from healthy children recruited with informed consent were analyzed for 16 Alinity immunoassays. The percentage of test results falling within published CALIPER ARCHITECT reference and confidence limits was determined. If ≥ 90% of test results fell within the confidence limits, they were considered verified based on CLSI guidelines. If <90% of test results fell within the confidence limits, additional samples were analyzed and new Alinity RIs were established. Results Of the 16 immunoassays assessed, 13 met the criteria for verification with test results from ≥ 90% of healthy serum samples falling within the published ARCHITECT confidence limits. New CALIPER RIs were established for free thyroxine and prolactin on the Alinity system. Estradiol required special considerations in early life. Conclusions Our data demonstrate excellent concordance between ARCHITECT and Alinity immunoassays, as well as the robustness of previously established CALIPER RIs for most immunoassays, eliminating the need for de novo RI studies for most parameters. Availability of pediatric RIs for immunoassays on the Alinity system will assist clinical laboratories using this new platform and contribute to improved clinical decision-making.

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Characteristics and Epidemiological Investigation of Paratuberculosis in Dairy Cattle in Tai’an, China

BioMed Research International ◽

10.1155/2020/3896754 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Zilong Cheng ◽

Mengda Liu ◽

Peng Wang ◽

Peng Liu ◽

Meng Chen ◽

...

Keyword(s):

Dairy Cattle ◽

Clinical Symptoms ◽

Shandong Province ◽

Chain Reaction ◽

Serum Samples ◽

Fatal Disease ◽

Ionization Time ◽

Flight Mass Spectrometry ◽

Subcutaneous Edema ◽

Polymerase Chain

Paratuberculosis, a chronic and sometimes fatal disease of ruminants, is caused by Mycobacterium avium subsp. paratuberculosis (MAP). In this study, we examined paratuberculosis cases among 2–4-year-old dairy cows at farms in Shandong Province, China. Paratuberculosis cases were diagnosed based on clinical symptoms, pathological autopsy, and histopathological inspection. Characteristics of paratuberculosis in the affected dairy cattle included poor body condition, persistent diarrhea, subcutaneous edema, granulomatous ileitis (multibacillary), mesenteric lymphadenitis, and hepatitis. Acid-fast bacilli from fecal specimens and lymphocytes were putatively identified as MAP based on Ziehl-Neelsen staining, then confirmed using polymerase chain reaction-based testing and matrix-assisted laser desorption/ionization time-of-flight mass spectrometry analyses. Overall, only one MAP strain was isolated from a herd with symptomatic diarrhea. However, analysis of 586 serum samples from nine herds in Tai’an City revealed that 66.7% of herds and 14.2% of animals were seropositive for MAP. Our findings suggest that paratuberculosis is widely prevalent and therefore a significant threat to the dairy industry in Tai’an City, Shandong Province, China.

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DETECTION OF SPECIFIC ANTIBODIES TO THE NUCLEOCAPSID PROTEIN FRAGMENTS OF SEVERE ACUTE RESPIRATORY SYNDROME-CORONAVIRUS AND SCOTOPHILUS BAT CORONAVIRUS-512 IN THREE INSECTIVOROUS BAT SPECIES

Taiwan Veterinary Journal ◽

10.1142/s1682648518500063 ◽

2018 ◽

Vol 44 (04) ◽

pp. 179-188 ◽

Cited By ~ 2

Author(s):

Yi-Ning Chen ◽

Bo-Gang Su ◽

Hung-Chang Chen ◽

Cheng-Han Chou ◽

Hsi-Chi Cheng

Keyword(s):

Severe Acute Respiratory Syndrome ◽

Nucleocapsid Protein ◽

Enzyme Linked Immunosorbent Assay ◽

Serum Samples ◽

Protein Fragments ◽

Specific Antibodies ◽

History Of ◽

Polymerase Chain ◽

Carboxyl Terminal ◽

Bat Coronavirus

Bats are the natural reservoirs of severe acute respiratory syndrome-coronavirus (SARS-CoV). Six Alphacoronavirus and five Betacoronavirus have been detected in many bat species, including SARS-related CoV and Middle East respiratory syndrome (MERS)-related CoV. In Taiwan, SARS-related CoV, belonging to Betacoronavirus, has been detected in Rhinolophus monoceros. Scotophilus bat CoV-512, belonging to Alphacoronavirus, has been detected in Scotophilus kuhlii, Miniopterus fuliginosus, and Rhinolophus monoceros by using reverse transcription polymerase chain reaction (RT-PCR). To understand the infection history of CoV in these three insectivorous bat populations, CoV-specific antibodies were surveyed by using western blot (WB) analysis and indirect enzyme-linked immunosorbent assay (ELISA). The carboxyl terminal fragment of nucleocapsid protein (N3) of SARS-CoV and Scotophilus bat CoV-512 were used as the antigen in the assays. Of the 52 serum samples obtained from Scotophilus kuhlii, 29 samples (56%) were tested positive for Scotophilus bat CoV-512-specific antibodies through ELISA. Of the 63 serum samples obtained from Rhinolophus monoceros, 9 samples were tested positive for only SARS-CoV-specific antibodies, 7 samples were tested positive for only Scotophilus bat CoV-512-specific antibodies, and 16 samples (25.4%) were tested positive for both antibodies through WB analysis. Only 1 of 18 Miniopterus bat serum samples tested positive for Scotophilus bat CoV-512-specific antibodies through ELISA. Lactating female bats had higher positive rates of CoV-specific antibodies than non-lactating female and male bats did. Our findings were crucial for understanding CoV infection history in three insectivorous bat species and important for the control of bat-borne zoonosis diseases.

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Characterization of Shedding Patterns of Porcine Circovirus Types 2a and 2b in Experimentally Inoculated Mature Boars

Journal of Veterinary Diagnostic Investigation ◽

10.1177/104063870802000603 ◽

2008 ◽

Vol 20 (6) ◽

pp. 725-734 ◽

Cited By ~ 38

Author(s):

Darin M. Madson ◽

Sheela Ramamoorthy ◽

Chris Kuster ◽

Narinder Pal ◽

Xiang-Jin Meng ◽

...

Keyword(s):

Sperm Morphology ◽

Porcine Circovirus ◽

Serum Samples ◽

Treatment Groups ◽

Swine Pathogen ◽

Polymerase Chain ◽

Swine Herds ◽

Negative Controls ◽

Group 1

Porcine circovirus-2 (PCV-2) is an economically important swine pathogen and causes PCV-associated disease (PCVAD) in pigs worldwide. Currently, 2 genotypes of PCV-2, PCV-2a and −2b, are circulating in U.S. swine herds. The objectives of the current study were to evaluate the amount of PCV-2 DNA present in semen over time, compare and correlate incidence and amount of PCV-2 present in semen samples to that present in serum samples and blood swabs, and determine if there are differences in shedding patterns between PCV-2a and −2b. Fifteen 7-month-old PCV-2-naïve Landrace boars ( Sus scrofa) were randomly allocated to 3 treatment groups. The boars in group 1 ( n = 3) served as negative controls, and those in groups 2 ( n = 6) and 3 ( n = 6) were intranasally and intramuscularly inoculated with PCV-2a and −2b, respectively. Semen, serum, and blood swab samples were collected up to 90 days postinoculation (DPI), and necropsies were performed on DPI 23,48, and 90. Larger quantities of both PCV-2a and − 2b DNA were detected earlier in serum and blood swab samples than in raw semen of experimentally inoculated boars. The incidence and duration of presence of PCV-2 DNA in semen varied among boars; however, intermittent shedding was not observed. In all sex glands, PCV-2 DNA was detected by polymerase chain reaction; however, PCV-2 antigen was not detected by immunohistochemistry, and PCV-2 had no effect on sperm morphology. Differences in shedding patterns between PCV-2a and −2b were not observed under the study conditions.

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1149. Application of a Multiplex Polymerase Chain Reaction Test for Diagnosing Bacterial Enteritis in Children in a Real-Life Clinical Setting

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1342 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S666-S666

Author(s):

Hyun Woo Lee ◽

Seung Beom Han ◽

Jung-Woo Rhim

Keyword(s):

Polymerase Chain Reaction ◽

Acute Gastroenteritis ◽

Multiplex Polymerase Chain Reaction ◽

Clinical Symptoms ◽

Real Life ◽

Gastrointestinal Symptoms ◽

Polymerase Chain Reaction Test ◽

Test Results ◽

Chain Reaction ◽

Polymerase Chain

Abstract Background Although a bacterial multiplex polymerase chain reaction (mPCR) test should be performed selectively in patients with gastrointestinal symptoms consistent with bacterial enteritis, its usefulness has been evaluated upon stool samples as requested by clinicians, without considering the patients’ gastrointestinal symptoms or clinical diagnoses. This study aimed to determine the subjects to bacterial mPCR testing and to interpret the mPCR test results with considering patients’ clinical symptoms and diagnoses. Methods Medical records of 710 pediatric patients for whom a bacterial mPCR test was performed were retrospectively reviewed. Clinical characteristics and mPCR test results were compared between patients with positive mPCR test results (n = 199) and those with negative mPCR test results (n = 511) and between patients in whom inflammatory pathogens (Campylobacter spp. and Salmonella spp.) were identified (n = 95) and those in whom toxigenic pathogens (Clostridium spp.) were identified (n = 70). Results A positive mPCR test result was significantly associated with an older age (p < 0.001), diagnosis of acute gastroenteritis (p = 0.021), presence of hematochezia (p < 0.001), and absence of cough (p = 0.004). The diagnosis of acute gastroenteritis (p = 0.003), presence of fever (p = 0.027) and diarrhea (p = 0.043), and a higher C-reactive protein level (p = 0.025) were significantly associated with the identification of inflammatory pathogens rather than toxigenic pathogens in patients with positive mPCR test results. Conclusion Bacterial mPCR testing should be performed selectively based on patients’ clinical symptoms and diagnoses, and its results should be interpreted with considering identified pathogens. Disclosures All Authors: No reported disclosures

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Viral Shedding among Re-Positive Severe Acute Respiratory Syndrome Coronavirus-2 Positive Individuals in Republic of Korea

Viruses ◽

10.3390/v13102089 ◽

2021 ◽

Vol 13 (10) ◽

pp. 2089

Author(s):

Jeong-Min Kim ◽

Boyeong Ryu ◽

Young June Choe ◽

Hye-Jun Jo ◽

Hyeokjin Lee ◽

...

Keyword(s):

Severe Acute Respiratory Syndrome ◽

Neutralizing Antibodies ◽

Index Patient ◽

Test Results ◽

Serological Tests ◽

Past Infection ◽

Viral Shedding ◽

Viral Culture ◽

Polymerase Chain ◽

Pcr Test

This study investigated the infectivity of severe acute respiratory syndrome (SARS-CoV-2) in individuals who re-tested positive for SARS-CoV-2 RNA after recovering from their primary illness. We investigated 295 individuals with re-positive SARS-CoV-2 polymerase chain reaction (PCR) test results and 836 of their close contacts. We attempted virus isolation in individuals with re-positive SARS-CoV-2 PCR test results using cell culture and confirmed the presence of neutralizing antibodies using serological tests. Viral culture was negative in all 108 individuals with re-positive SARS-CoV-2 PCR test results in whom viral culture was performed. Three new cases of SARS-CoV-2 infection were identified among household contacts using PCR. Two of the three new cases had had contact with the index patient during their primary illness, and all three had antibody evidence of past infection. Thus, there was no laboratory evidence of viral shedding and no epidemiological evidence of transmission among individuals with re-positive SARS-CoV-2 PCR test results.

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IgG antibody response against Nucleocapsid and Spike protein post SARS-CoV-2 infection

10.21203/rs.3.rs-490375/v1 ◽

2021 ◽

Author(s):

Hari Ram Choudhary ◽

Debaprasad Parai ◽

Girish Chandra Dash ◽

Annalisha Peter ◽

Subrat Kumar Sahoo ◽

...

Keyword(s):

Spike Protein ◽

Complete Disappearance ◽

Serum Samples ◽

Igg Antibody ◽

Observational Cohort ◽

Public Health Challenge ◽

Qualitative Assay ◽

Polymerase Chain ◽

Abbott Architect

Abstract Objectives: Coronavirus disease-19 (COVID-19) pandemic became the greatest public health challenge globally. Study of dynamicity and durability of naturally developed antibodies against SARS-CoV-2 are of great importance from an epidemiological viewpoint.Methods: In this observational cohort study, we have followed up the 76 individuals who tested positive for SARS-CoV-2 infection by real-time reverse transcriptase-polymerase chain reaction (RT-qPCR) for 16 weeks (post enrollment) to record the periodic changes in titre, concentration, clinical growth and persistence of naturally developed SARS-CoV-2 antibodies. We collected serum samples from these individuals for 16 weeks with a frequency of weekly and fortnightly during each follow-up and tested them in two CLIA-based platforms (Abbott Architect i1000SR and Roche Cobas e411) for testing SARS-CoV-2 antibodies both qualitatively and quantitatively.Results: We recorded the antibody magnitude of these individuals 10 times between September 2020 and February 2021. We found a waning of antibodies against nucleocapsid antigen protein but not a complete disappearance by the end of 16 weeks. Out of 76 cases, 30 cases (39.47%) became seronegative in qualitative assay, although all the sera samples (100%) remained positive when tested in quantitative assay.Conclusion: The lower persistence of anti-nucleocapsid SARS-CoV-2 antibody may not be the exact phenomenon as those cases were still seropositive against spike protein and help in neutralizing the virus.

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COVID-19 with repeated positive test results for SARS-CoV-2 by PCR and then negative test results twice during intensive care: a case report

Journal of Medical Case Reports ◽

10.1186/s13256-020-02534-2 ◽

2020 ◽

Vol 14 (1) ◽

Author(s):

Masafumi Kanamoto ◽

Masaru Tobe ◽

Tomonori Takazawa ◽

Shigeru Saito

Keyword(s):

Polymerase Chain Reaction ◽

Intensive Care ◽

Clinical Symptoms ◽

Polymerase Chain Reaction Test ◽

Test Results ◽

Chain Reaction ◽

Negative Test ◽

Computed Tomographic ◽

Polymerase Chain ◽

Test Result

Abstract Background Determining the infectiousness of patients with coronavirus disease 2019 is crucial for patient management. Medical staff usually refer to the results of reverse transcription polymerase chain reaction tests in conjunction with clinical symptoms and computed tomographic images. Case presentation We report a case of a 62-year-old Japanese man who twice had positive and negative test results by polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 over 48 days of hospitalization, including in intensive care. His respiratory symptoms and computed tomographic imaging findings consistent with coronavirus disease 2019 improved following initial intensive care, and the result of his polymerase chain reaction test became negative 3 days before discharge from the intensive care unit. However, 4 days after this first negative result, his polymerase chain reaction test result was positive again, and another 4 days later, he had a negative result once more. Eight days after the second polymerase chain reaction negative test result, the patient’s test result again became positive. Finally, his polymerase chain reaction results were negative 43 days after his first hospitalization. Conclusions This case emphasizes the importance of repeat polymerase chain reaction testing and diagnosis based on multiple criteria, including clinical symptoms and computed tomographic imaging findings. Clinical staff should consider that a negative result by polymerase chain reaction does not necessarily certify complete coronavirus disease 2019 recovery.

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Differences in Performance Characteristics Among Four High-Throughput Assays for the Detection of Antibodies Against SARS-CoV-2 Using a Common Set of Patient Samples

American Journal of Clinical Pathology ◽

10.1093/ajcp/aqaa200 ◽

2020 ◽

Cited By ~ 3

Author(s):

David M Manthei ◽

Jason F Whalen ◽

Lee F Schroeder ◽

Anthony M Sinay ◽

Shih-Hon Li ◽

...

Keyword(s):

Symptom Onset ◽

Performance Characteristics ◽

Clinical Test ◽

Test Results ◽

Rt Pcr ◽

Serum Samples ◽

Specificity And Sensitivity ◽

Antibody Assays ◽

Polymerase Chain ◽

Serology Testing

Abstract Objectives Serologic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has experienced a changing landscape of available assays coupled with uncertainty surrounding performance characteristics. Studies are needed to directly compare multiple commercially available assays. Methods Residual serum samples were identified based on SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) testing, clinical test results, and collection dates. Serum samples were analyzed using assays from four different manufacturers: DiaSorin anti–SARS-CoV-2 S1/S2 IgG, EUROIMMUN anti–SARS-CoV-2 IgG ELISA, Roche Elecsys anti–SARS-CoV-2, and Siemens SARS-CoV-2 Total antibody assays. Results Samples from SARS-CoV-2 RT-PCR–positive patients became increasingly positive as time from symptom onset increased. For patients with latest sample 14 or more days after symptom onset, sensitivities reached 93.1% to 96.6%, 98.3%, and 96.6% for EUROIMMUN, Roche, and Siemens assays, respectively, which were superior to the DiaSorin assay at 87.7%. The specificity of Roche and Siemens assays was 100% and superior to DiaSorin and EUROIMMUN assays, which ranged from 96.1% to 97.0% and 86.3% to 96.4%, respectively. Conclusions Laboratories should be aware of the advantages and limitations of serology testing options for SARS-CoV-2. The specificity and sensitivity achieved by the Roche and Siemens assays would be acceptable for testing in lower-prevalence regions and have the potential of orthogonal testing advantages if used in combination.

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Application of a Multiplex Polymerase Chain Reaction Test for Diagnosing Bacterial Enteritis in Children in a Real-Life Clinical Setting

Children ◽

10.3390/children8070538 ◽

2021 ◽

Vol 8 (7) ◽

pp. 538

Author(s):

Hyun-Woo Lee ◽

Seung-Beom Han ◽

Jung-Woo Rhim

Keyword(s):

Polymerase Chain Reaction ◽

Acute Gastroenteritis ◽

Multiplex Polymerase Chain Reaction ◽

Clinical Symptoms ◽

Real Life ◽

Polymerase Chain Reaction Test ◽

Test Results ◽

Chain Reaction ◽

Invasive Pathogens ◽

Polymerase Chain

This study aimed to determine the subjects for bacterial multiplex polymerase chain reaction (mPCR) testing and to interpret the mPCR test results based on patients’ clinical symptoms and diagnoses. The medical records of 710 pediatric patients who underwent a bacterial mPCR test were retrospectively reviewed. Clinical characteristics and mPCR test results were compared between patients with positive (n = 199) and negative mPCR test results (n = 511) and between patients with invasive pathogens (n = 95) and toxigenic pathogens (n = 70). Positive mPCR test results were significantly associated with older age (p < 0.001), diagnosis of acute gastroenteritis (p = 0.021), presence of hematochezia (p < 0.001), and absence of cough (p = 0.004). The diagnosis of acute gastroenteritis (p = 0.003), presence of fever (p = 0.027) and diarrhea (p = 0.043), and higher C-reactive protein levels (p = 0.025) were significantly associated with the identification of invasive pathogens in patients with positive mPCR test results. Thus, selective bacterial mPCR testing should be performed based on the patients’ clinical symptoms and diagnoses, and the results should be interpreted in consideration with identified pathogens.

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