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Id Subject Object Predicate Lexical cue
T1 0-133 Sentence denotes Sensitivity and specificity of 14 SARS-CoV-2 serological assays and their diagnostic potential in RT-PCR negative COVID-19 infections
T2 134-136 Sentence denotes E.
T3 137-156 Sentence denotes VAN HONACKER ET AL.
T4 157-177 Sentence denotes ACTA CLINICA BELGICA
T5 179-187 Sentence denotes Abstract
T6 188-196 Sentence denotes ABSTRACT
T7 197-208 Sentence denotes Background:
T8 209-384 Sentence denotes Molecular detection of SARS-CoV-2 in respiratory samples is the gold standard for COVID-19 diagnosis but it has a long turnaround time and struggles to detect low viral loads.
T9 385-467 Sentence denotes Serology could help to diagnose suspected cases which lack molecular confirmation.
T10 468-515 Sentence denotes Two case reports are presented as illustration.
T11 516-527 Sentence denotes Objectives:
T12 528-633 Sentence denotes The aim of this study was to evaluate the performance of several commercial assays for COVID-19 serology.
T13 634-749 Sentence denotes We illustrated the added value of COVID-19 serology testing in suspect COVID-19 cases with negative molecular test.
T14 750-763 Sentence denotes Study design:
T15 764-888 Sentence denotes Twenty-three sera from 7 patients with a confirmed molecular diagnosis of SARS-CoV-2 were tested using 14 commercial assays.
T16 889-976 Sentence denotes Additionally, 10 pre-pandemic sera and 9 potentially cross-reactive sera were selected.
T17 977-1019 Sentence denotes We calculated sensitivity and specificity.
T18 1020-1214 Sentence denotes Furthermore, we discuss the diagnostic relevance of COVID-19 serology in a retrospective cohort of 145 COVID-19 cases in which repetitive molecular and serological SARS-CoV-2 tests were applied.
T19 1215-1223 Sentence denotes Results:
T20 1224-1363 Sentence denotes The interpretation of the pooled sensitivity of IgM/A and IgG resulted in the highest values (range 14–71% on day 2–7; 88–94% on day 8–18).
T21 1364-1428 Sentence denotes Overall, the specificity of the assays was high (range 79–100%).
T22 1429-1568 Sentence denotes Among 145 retrospective cases, 3 cases (2%) remained negative after sequential molecular testing but positive on final SARS-CoV-2 serology.
T23 1569-1580 Sentence denotes Conclusion:
T24 1581-1698 Sentence denotes Sensitivity of COVID-19 serological diagnosis was variable but consistently increased at >7 days after symptom onset.
T25 1699-1720 Sentence denotes Specificity was high.
T26 1721-1889 Sentence denotes Our data suggest that serology can complement molecular testing for diagnosis of COVID-19, especially for patients presenting the 2nd week after symptom onset or later.
T27 1891-1901 Sentence denotes Background
T28 1902-2004 Sentence denotes In December 2019, several cases of an unidentified pneumonia occurred in the province of Hubei, China.
T29 2005-2141 Sentence denotes With the use of next-generation sequencing, the Wuhan Institute of Virology identified a new coronavirus as the etiological agent [1,2].
T30 2142-2271 Sentence denotes This new virus, which belongs to the genus betacoronavirus, was initially acknowledged as novel coronavirus 2019 (2019-nCOV) [3].
T31 2272-2449 Sentence denotes On 11 February 2020, the virus was officially renamed the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by the International Committee on Taxonomy of Viruses [4].
T32 2450-2605 Sentence denotes Since then the virus has rapidly spread and on the 18th of July 2020, over 14 million confirmed cases and 600 000 direct casualties have been reported [5].
T33 2606-2771 Sentence denotes So far, implementation of strict quarantine measures have contained further exponential spreading of the virus in Europe and have flattened the first epidemic curve.
T34 2772-2942 Sentence denotes Considering the extent of the pandemic, its socio-economic impact, and the effect on healthcare systems worldwide, there is a high need to extend the diagnostic capacity.
T35 2943-3118 Sentence denotes So far, the gold standard for the diagnosis of SARS-CoV-2, implemented at the start of the outbreak, is real-time reverse transcriptase polymerase chain reaction (RT-PCR) [6].
T36 3119-3269 Sentence denotes In contrast with a high specificity up to 98.8% [7], RT-PCR suffers from a rather long turnaround time when performed in batch testing (2 to 6 hours).
T37 3270-3347 Sentence denotes Continuous PCR testing has a faster turnaround time (1 u) but a low capacity.
T38 3348-3510 Sentence denotes False negative results in both the very early as well as the late phase of the disease due to low virus shedding at these stages of infection are reported [8–10].
T39 3511-3616 Sentence denotes Studies have shown discrepant results between RT-PCR and chest computed tomography (CT) findings [11,12].
T40 3617-3787 Sentence denotes CT imaging findings in 30 patients with suspicion of COVID-19 pneumonia were shown to have a sensitivity of 97.2% compared to 83.3% of initial nasopharyngeal RT-PCR [13].
T41 3788-3899 Sentence denotes Establishing the diagnosis of COVID-19 is sometimes very challenging and does not only rely on molecular tests.
T42 3900-4062 Sentence denotes We report on two patients who presented at the emergency department with high suspicion of COVID-19 infection based on clinical findings and/or chest-CT findings.
T43 4063-4179 Sentence denotes Nevertheless, SARS-CoV-2 RT-PCR testing was repeatedly negative on repetitive nasopharyngeal, throat and anal swabs.
T44 4180-4291 Sentence denotes Case 1 was a 66 year old male experiencing symptoms of shortness of breath, fever and muscle pain since 8 days.
T45 4292-4341 Sentence denotes Lab findings showed thrombopenia (87,000/µL, ref.
T46 4342-4388 Sentence denotes 149,000–31,9000/µL), lymphopenia (930/µL, ref.
T47 4389-4445 Sentence denotes 1,133–3,105/µL), normal neutrophil count (2,980/µL, ref.
T48 4446-4494 Sentence denotes 1,573–6,100/µL) low eosinophil count (0/µL, ref.
T49 4495-4541 Sentence denotes 28–273/µL), normal basophil count (10/µL, ref.
T50 4542-4656 Sentence denotes 6–50/µL), elevated D-dimers (1,480 ng/mL, ref. <500 ng/mL) and elevated C-reactive protein (29 mg/L, ref <5 mg/L).
T51 4657-4856 Sentence denotes Chest CT on the day of admission showed bilateral ground glass opacities with a crazy paving pattern suspicious for COVID-19 (CT severity score of 10 or CO-RADS classification of 4: COVID-19 likely).
T52 4857-5064 Sentence denotes Repetitive nasopharyngeal swabs on day 8, 9, 12 and 13 as well as anal swabs on day 9 and 13 after symptom onset were all SARS-CoV-2 RT-PCR negative using the protocol described by Corman and colleagues [6].
T53 5065-5196 Sentence denotes Serology on day 13 after symptom onset indicated negative IgM but positive IgG (Prima Professional®, Point-Of-Care antibody Tests).
T54 5197-5328 Sentence denotes On day 13, the patient was admitted to the intensive care unit (ICU) because of type 1 respiratory insufficiency (pO2 60 mmHg, ref.
T55 5329-5361 Sentence denotes 83–108 mm Hg; pCO2 31 mmHg, ref.
T56 5362-5388 Sentence denotes 35–45 mm Hg; pH 7.46, ref.
T57 5389-5400 Sentence denotes 7.35–7.45).
T58 5401-5443 Sentence denotes He did not require mechanical ventilation.
T59 5444-5500 Sentence denotes Based on these findings, he was diagnosed with COVID-19.
T60 5501-5648 Sentence denotes Case 2 was a 14 year old child presenting at the emergency room with 3 days of fever > 39°C, muscle pain, cough, sore throat, headache and fatigue.
T61 5649-5778 Sentence denotes The girl’s father had suffered from fever and respiratory symptoms after contact with multiple COVID-19 patients 4 weeks earlier.
T62 5779-5941 Sentence denotes On day 4 after symptom onset, there was a clinical deterioration to refractory shock and multi-organ failure with hypotension and respiratory and cardiac failure.
T63 5942-5991 Sentence denotes Lab findings showed thrombopenia (89,000/µL, ref.
T64 5992-6038 Sentence denotes 154,000–452,000/µL), lymphopenia (162/µL, ref.
T65 6039-6095 Sentence denotes 1,500–6,500/µL), normal neutrophil count (7,564/µL, ref.
T66 6096-6147 Sentence denotes 2,500–8,000), normal eosinophil count (283/µL, ref.
T67 6148-6191 Sentence denotes 100–500/µL), low basophil count (0/µL, ref.
T68 6192-6306 Sentence denotes 10–100/µL), elevated D-dimers (4,420 ng/mL, ref. <500 ng/mL) and high C-reactive protein (308 mg/L, ref. <5 mg/L).
T69 6307-6354 Sentence denotes Chest CT did not show signs of viral pneumonia.
T70 6355-6417 Sentence denotes Echocardiography revealed decreased left ventricular function.
T71 6418-6488 Sentence denotes She responded well to supportive therapy and corticosteroid treatment.
T72 6489-6582 Sentence denotes Throat swabs on day 3 and 5 after symptom onset were negative for SARS-CoV-2 with RT-PCR [6].
T73 6583-6685 Sentence denotes Serology on day 8 after symptom onset was negative for IgM but positive for IgG (Prima Professional®).
T74 6686-6799 Sentence denotes She was diagnosed with pediatric inflammatory multisystem syndrome temporally associated with COVID-19 (PIMS-TS).
T75 6800-6915 Sentence denotes The case reports mentioned above point out the potential of serological assays to add to the diagnosis of COVID-19.
T76 6916-7021 Sentence denotes So far, a large number of serological assays have been developed in response to the diagnostic need [14].
T77 7022-7138 Sentence denotes Data on the validation and comparison of the performance of these assays are emerging but are still limited [15–18].
T78 7139-7315 Sentence denotes Since antibody production by the specific immune system is subject to delay, a lower diagnostic performance of serological assays in the early phase of the disease is expected.
T79 7316-7434 Sentence denotes So far, studies have revealed that antibodies could be detected as early as 3–6 days after symptom onset [9,10,19,20].
T80 7436-7446 Sentence denotes Objectives
T81 7447-7777 Sentence denotes The main goal of this study was to evaluate the performance of 5 five Point-Of-Care antibody Tests, one chemiluminescence microparticle immunoassay (CMIA), one chemiluminescence immunoassay (CLIA) and 7 enzyme-linked immunosorbent assays (ELISA) for COVID-19 serology in an attempt to validate and select the best performing ones.
T82 7778-7949 Sentence denotes Secondly, we discuss the role of SARS-CoV-2 serology in the process of diagnosing COVID-19 disease in presumable COVID-19 cases with sequential negative SARS-CoV-2 RT-PCR.
T83 7951-7963 Sentence denotes Study design
T84 7964-8117 Sentence denotes The study was approved by the local ethics committee (BC-07829) of the Ghent University Hospital, a 1062-beds tertiary care teaching hospital in Belgium.
T85 8118-8339 Sentence denotes From March 12th to 31st 2020, 23 consecutive sera from 7 different patients, admitted to the hospital with a confirmed diagnosis of COVID-19 based on positive RT-PCR [6], were collected on day 2 to 18 after symptom onset.
T86 8340-8391 Sentence denotes The study group consisted of 2 females and 5 males.
T87 8392-8440 Sentence denotes The median age was 58 years (range 39–81 years).
T88 8441-8616 Sentence denotes The collected sera were divided into 2 groups: day 2–7 after symptom onset (7 samples) and day 8–18 after symptom onset (16 samples) in order to evaluate clinical sensitivity.
T89 8617-8807 Sentence denotes Specificity was evaluated using 10 pre-pandemic sera, i.e. clinical samples sent to the hospital laboratory for non-COVID-19-related serological investigations from August to September 2019.
T90 8808-9179 Sentence denotes Furthermore, 9 potential cross-reactive sera were included, i.e. IgM positivity against Cytomegalovirus (CMV) (n = 2), Epstein-Barr virus (EBV) (n = 2) or Toxoplasma gondii (Toxo) (n = 1); samples positive for rheumafactor (RF) (n = 1) or anti-nuclear factor (ANF) (n = 1)) and sera from patients positive for non-SARS-CoV-2 endemic coronaviruses (OC43 and NL63) (n = 2).
T91 9180-9398 Sentence denotes The 14 serological assays listed in Table 1 were performed on each of the 23 sera from PCR confirmed COVID-19 positive patients and the 19 pre-pandemic/cross-reactive sera, according to the manufacturer’s instructions.
T92 9399-9457 Sentence denotes Sensitivity and specificity were calculated for each test.
T93 9458-9675 Sentence denotes We calculated both the overall sensitivity (day 2–18 after symptom onset) and the sensitivity of the two subgroups (day 2–7 and day 8–18), each time for IgM/A and IgG separately and for combined IgM/A and IgG testing.
T94 9676-9684 Sentence denotes Table 1.
T95 9685-9716 Sentence denotes Overview of the included assays
T96 9717-9774 Sentence denotes Test Assay Company Antibody detection Recombinant antigen
T97 9775-9793 Sentence denotes Point-of-care test
T98 9794-9883 Sentence denotes Corona Virus (COVID-19) Combined IgM/IgG Rapid Test Sol Scientifics IgM+IgG Not specified
T99 9884-9986 Sentence denotes COVID-19 IgG/igM Rapid Test Cassette Zhejiang ORIENT GENE Biotech IgM+IgG Spike + nucleocapsid protein
T100 9987-10097 Sentence denotes Wantai SARS-COV-2 Ab Rapid Test Beijing Wantai Biological Pharmacy Enterprise IgM+IgG (combined) Not specified
T101 10098-10166 Sentence denotes COVID-19 IgG/IgM RAPID TEST PRIMA PROFESSIONAL IgM+IgG Not specified
T102 10167-10250 Sentence denotes Diagnostic Kit for IgG/IgM Antibody to SARS-CoV-2 WIZ BIOTECH IgM+IgG Not specified
T103 10251-10292 Sentence denotes Enzyme-Linked Immunosorbent Assay (ELISA)
T104 10293-10363 Sentence denotes Anti-SARS-CoV-2 ELISA (IgA) EUROIMMUN S1 Spike glycoprotein (S1domain)
T105 10364-10435 Sentence denotes Anti-SARS-CoV-2 ELISA (IgG) EUROIMMUN IgG Spike glycoprotein (S1domain)
T106 10436-10520 Sentence denotes Novel Coronavirus COVID-19 IgM ELISA Kit Epitope Diagnostics (EDI) IgM Not specified
T107 10521-10612 Sentence denotes Novel Coronavirus COVID-19 IgG ELISA Kit Epitope Diagnostics (EDI) IgG Nucleocapsid protein
T108 10613-10676 Sentence denotes SARS-CoV-2 IgM ELISA Kit Creative Diagnostics IgM Not specified
T109 10677-10740 Sentence denotes SARS-CoV-2 IgG ELISA kit Creative Diagnostics IgG Not specified
T110 10741-10817 Sentence denotes Human Anti-2019 nCoV(N) IgG ELISA kit Finetest, Wuhan Fine Biotech Co., Ltd.
T111 10818-10851 Sentence denotes IgG Spike glycoprotein (S1domain)
T112 10852-10901 Sentence denotes Chemiluminescent microparticle immunoassay (CMIA)
T113 10902-10948 Sentence denotes SARS-CoV-2 IgG Abbott IgG Nucleocapsid protein
T114 10949-10985 Sentence denotes Chemiluminescence immunoassay (CLIA)
T115 10986-11045 Sentence denotes Liaison SARS-CoV-2 S1/S2 IgG DiaSorin IgG S1 and S2 protein
T116 11046-11192 Sentence denotes Sensitivity and specificity were calculated by means of Excel (version 16.0, Microsoft, Washington, USA) using the following definitions in Excel:
T117 11193-11261 Sentence denotes Sensitivity = 100 x [True Positive/(True Positive + False Negative)]
T118 11262-11329 Sentence denotes Specificity = 100 x [True Negative/(True Negative +False Positive)]
T119 11330-11632 Sentence denotes All patients consulting at the emergency department of our hospital from the 1st of March till the 14th of May, with symptoms suggestive of COVID-19 disease that required hospital admission and for which laboratory diagnosis was performed in our institution were retrospectively included in a database.
T120 11633-11732 Sentence denotes In all patients a RT-PCR test on nasopharyngeal/throat swab was performed at the time of admission.
T121 11733-11857 Sentence denotes If the initial nasopharyngeal swab was found to be negative, a second nasopharyngeal and additional anal swab were analyzed.
T122 11858-11922 Sentence denotes If still negative, a bronchoalveolar lavage (BAL) was performed.
T123 11923-12169 Sentence denotes Patients with repetitive negative molecular testing for SARS-CoV-2 but high clinical, epidemiological and/or radiological suspicion of COVID-19 disease were subjected to serological testing using COVID-19 IgG/IgM rapid test (Prima Professional®).
T124 12170-12354 Sentence denotes Among this retrospective cohort of hospitalized patients clinically treated for COVID-19 disease, we calculated the number of patients that ultimately had a RT-PCR confirmed diagnosis.
T125 12355-12466 Sentence denotes As such, an estimation of the added diagnostic value of SARS-CoV-2 serology in this cohort could be calculated.
T126 12468-12475 Sentence denotes Results
T127 12476-12578 Sentence denotes Sensitivity on day 2–7 after symptom onset ranged from 0% to 57% for IgM/A and from 0% to 71% for IgG.
T128 12579-12684 Sentence denotes Sensitivity on day 8–18 after symptom onset ranged from 50% to 94% for IgM/A and from 81% to 94% for IgG.
T129 12685-12888 Sentence denotes If IgA/M and IgG were both available, the combined IgM/A and IgG sensitivity result was consistently higher than the separate interpretation (range 14–71% on day 2–7 and 88–94% on day 8–18; see Table 2).
T130 12889-12897 Sentence denotes Table 2.
T131 12898-12944 Sentence denotes Sensitivity and specificity of all test assays
T132 12945-13038 Sentence denotes Test Assay Sensitivity day 2–7 Sensitivity day 8–18 Overall sensitivity day 2-d18 Specificity
T133 13039-13109 Sentence denotes   IgM* IgG IgM* + IgG IgM* IgG IgM* + IgG IgM* IgG IgM* + IgG IgM* IgG
T134 13110-13150 Sentence denotes Point-of-care test                      
T135 13151-13265 Sentence denotes Corona Virus (COVID-19) Combined IgM/IgG Rapid test (Sol scientifics) 57% 14% 57% 94% 88% 94% 83% 65% 83% 79% 100%
T136 13266-13362 Sentence denotes COVID-19 IgG/IgM Rapid test Cassette (Orient Gene) 43% 29% 43% 94% 88% 94% 78% 70% 78% 100% 100%
T137 13363-13406 Sentence denotes SARS-CoV-2 Ab rapid test (Wantai) n.a. n.a.
T138 13407-13420 Sentence denotes 43% n.a. n.a.
T139 13421-13434 Sentence denotes 94% n.a. n.a.
T140 13435-13443 Sentence denotes 78% n.a.
T141 13444-13448 Sentence denotes 100%
T142 13449-13541 Sentence denotes COVID-19 IgG/IgM RAPID TEST (PRIMA PROFESSIONAL) 0% 29% 29% 50% 81% 88% 35% 65% 70% 95% 100%
T143 13542-13650 Sentence denotes Diagnostic Kit for IgG/IgM Antibody to SARS-CoV-2 (WIZ BIOTECH) 14% 14% 14% 94% 94% 94% 70% 70% 70% 95% 100%
T144 13651-13714 Sentence denotes Enzyme-Linked Immunosorbent Assay (ELISA)                      
T145 13715-13788 Sentence denotes Anti-SARS-CoV-2 (EUROIMMUN)* 57% 29% 57% 94% 88% 94% 83% 70% 83% 95% 100%
T146 13789-13881 Sentence denotes Novel Coronavirus COVID-19 (Epitope Diagnostics) 29% 71% 71% 69% 94% 94% 57% 87% 87% 95% 89%
T147 13882-13975 Sentence denotes SARS-CoV-2 IgG ELISA Kit (Creative Diagnostics) 29% 14% 29% 94% 88% 94% 74% 65% 74% 100% 100%
T148 13976-14029 Sentence denotes Human Anti-2019 nCoV(N) IgG ELISA kit (Finetest) n.a.
T149 14030-14043 Sentence denotes 29% n.a. n.a.
T150 14044-14057 Sentence denotes 88% n.a. n.a.
T151 14058-14071 Sentence denotes 70% n.a. n.a.
T152 14072-14075 Sentence denotes 83%
T153 14076-14145 Sentence denotes Chemiluminescent microparticle immunoassay (CMIA)                    
T154 14146-14174 Sentence denotes SARS-CoV-2 IgG (Abbott) n.a.
T155 14175-14188 Sentence denotes 29% n.a. n.a.
T156 14189-14202 Sentence denotes 88% n.a. n.a.
T157 14203-14216 Sentence denotes 70% n.a. n.a.
T158 14217-14221 Sentence denotes 100%
T159 14222-14280 Sentence denotes Chemiluminescence immunoassay (CLIA)                      
T160 14281-14325 Sentence denotes Liaison SARS-CoV-2 S1/S2 IgG (DiaSorin) n.a.
T161 14326-14338 Sentence denotes 0% n.a. n.a.
T162 14339-14352 Sentence denotes 81% n.a. n.a.
T163 14353-14366 Sentence denotes 59% n.a. n.a.
T164 14367-14371 Sentence denotes 100%
T165 14372-14401 Sentence denotes Anti-SARS-CoV-2 (EUROIMMUN)*:
T166 14402-14442 Sentence denotes IgA instead of IgM; n.a.: not applicable
T167 14443-14530 Sentence denotes Overall the specificity for SARS-CoV-2 IgG was excellent (100%) for all but two assays:
T168 14531-14788 Sentence denotes The Novel Coronavirus COVID-19 (Epitope Diagnostics) kit showed cross reaction with Toxo IgM+ sample and one pre-pandemic sample and the Human Anti-2019 nCoV(N) IgG ELISA kit (Finetest) showed cross reaction with Toxo IgM+ sample and 2 pre-pandemic samples.
T169 14789-14947 Sentence denotes For IgM, only two assays showed a specificity of 100%: COVID-19 IgG/IgM Rapid test Cassette (Orient Gene) and SARS-CoV-2 IgG ELISA Kit (Creative Diagnostics).
T170 14948-15550 Sentence denotes The other assays cross reacted with one or more samples: the combined IgM/IgG Rapid Test IgM (Sol scientific®) showed cross-reaction with CMV IgM+ sample, ANF+ sample, RF+ sample and Tox IgM+ sample, the COVID-19 IgG/IgM RAPID TEST IgM (PRIMA PROFESSIONAL®) showed cross-reaction with EBV IgM+, the Diagnostic Kit for IgG/IgM Antibody to SARS-CoV-2 IgM (WIZ BIOTECH) showed cross-reaction with RF+ sera, the Anti-SARS-CoV-2 ELISA IgA (EUROIMMUN®) showed cross-reaction with CMV IgM+ sample and the Novel Coronavirus COVID-19 IgM (Epitope Diagnostics®) had a cross-reaction with one pre-pandemic sample.
T171 15551-15669 Sentence denotes In our institution a total of 145 patients were hospitalized with an in-house laboratory confirmed COVID-19 diagnosis.
T172 15670-15808 Sentence denotes In this group, the presence of SARS-CoV-2 was confirmed using RT-PCR on the first nasopharyngeal and/or throat swab in 132 patients (91%).
T173 15809-15904 Sentence denotes Another 4 patients were diagnosed with a second nasopharyngeal and 1 patient with an anal swab.
T174 15905-15963 Sentence denotes Next, 5 patients were found to be positive on BAL samples.
T175 15964-16017 Sentence denotes Three patients remained negative on repetitive swabs.
T176 16018-16171 Sentence denotes These patients were not eligible for a BAL sampling procedure or did not present with respiratory symptoms and as such serological testing was performed.
T177 16172-16263 Sentence denotes All 3 patients were found to be positive for IgG SARS-CoV-2 serology (Prima Professional®).
T178 16264-16463 Sentence denotes Given the high pre-test probability for SARS-Cov-2 in this prospective cohort and repetitive testing, the added diagnostic value of SARS-CoV-2 serology in providing a diagnosis in this cohort was 2%.
T179 16465-16475 Sentence denotes Discussion
T180 16476-16595 Sentence denotes In this study, we evaluated the detection of SARS-CoV-2 antibodies (IgM/A or IgG) with 14 different serological assays.
T181 16596-16748 Sentence denotes As expected, we found that sensitivity was higher if the test was performed starting from day 8 after symptom onset, as compared to earlier time points.
T182 16749-16923 Sentence denotes With the exception of one assay (Liaison SARS-CoV-2 S1/S2 IgG (DiaSorin), all tests resulted in a sensitivity for IgG higher than 87% starting from day 8 after symptom onset.
T183 16924-16957 Sentence denotes Specificity ranged from 79%-100%.
T184 16958-17052 Sentence denotes Recently, the first studies evaluating several commercial serology assays have been published.
T185 17053-17167 Sentence denotes Geurts van Kessel et al [17]. studied three rapid tests, four ELISAs and a high throughput chemiluminescent assay.
T186 17168-17289 Sentence denotes Sensitivity ranging from 81–100% was calculated by using a total of 187 sera from 107 RT-PCR confirmed COVID-19 patients.
T187 17290-17463 Sentence denotes Specificity was determined using 147 serum and plasma samples from individuals exposed to human coronaviruses and other respiratory viruses with values ranging from 85–100%.
T188 17464-17680 Sentence denotes Similar to our findings, the performance of the Liaison SARS-CoV-2 S1/S2 IgG (DiaSorin) was worst with a sensitivity of 81% (compared to 59% in our results) and specificity of 90% (compared with 100% in our results).
T189 17681-17926 Sentence denotes The group of Haselmann et al [16]. evaluated the performance of two IgG ELISA assays and one IgG electrochemiluminescence immunoassay (ECLIA) based on 51 serum samples from 26 COVID-19 patients and another 51 serum samples from control patients.
T190 17927-17990 Sentence denotes They report a sensitivity of 92–100% and specificity of 84–96%.
T191 17991-18314 Sentence denotes The Austrian Red Cross Blood Service [15] evaluated 100 SARS-CoV-2 convalescent plasma donors and SARS-CoV-2 antibodies were characterized using three different IgG-ELISAs (EUROIMMUN IgG and NCP-IgG ELISA, Wantai ELISA), two CLIA (Elecsys, LIAISON) and two lateral flow tests (MEDsan IgM/IgG-Rapid-Test, Wantai Rapid Test).
T192 18315-18425 Sentence denotes The Wantai ELISA and the Elecsys provided the highest sensitivities in this sample (98 and 95 % respectively).
T193 18426-18638 Sentence denotes Serrano et al [18]. compared the performance of 3 lateral flow immunoassays (IgM/IgG combined) to 2 ELISAs (IgA and IgG) in serum samples from 109 RT-PCR confirmed patients in different weeks after symptom onset.
T194 18639-18713 Sentence denotes The IgA ELISA was most sensitive the first week after symptom onset (71%).
T195 18714-18779 Sentence denotes The sensitivity improved to 97% for IgA ELISA in the second week.
T196 18780-18881 Sentence denotes In the third week IgA ELISA, IgG ELISA and 2 out 3 IgG lateral flow tests had a sensitivity of > 96%.
T197 18882-18941 Sentence denotes The lateral flow immunoassays showed variable performances.
T198 18942-19073 Sentence denotes Pieri et al. also found that IgA detected by the ELISA assay might be a more reliable and stable early serological marker than IgM.
T199 19074-19160 Sentence denotes Instead, IgG, as expected, showed stable level after 10 days from symptoms onset [21].
T200 19161-19217 Sentence denotes These findings are in accordance with our study results.
T201 19218-19278 Sentence denotes Serological tests could be useful in some clinical settings.
T202 19279-19392 Sentence denotes In our database, we found an added diagnostic value of serological assays in 2% of the COVID-19 suspect patients.
T203 19393-19541 Sentence denotes Although the detection of SARS-CoV-2 antibodies does not provide information on the presence of the viral RNA, it confirms recent or past infection.
T204 19542-19677 Sentence denotes This is especially relevant in clinical cases where high clinical suspicion for COVID-19 which cannot be confirmed with SARS-CoV-2 PCR.
T205 19678-19853 Sentence denotes The availability of these serological tests might avoid the need for more invasive sampling methods like BAL in the pursuit of diagnostic confirmation of COVID-19, especially.
T206 19854-19919 Sentence denotes Furthermore, serology can aid in infection prevention management.
T207 19920-20126 Sentence denotes Nuccetelli et al. suggest screening flowcharts for asymptomatic workers that is based on serological assays, workers that have already overcome the disease are subjected to molecular screening methods [22].
T208 20127-20261 Sentence denotes Next the development of antigen detection assays are underway, which have the potential to rapidly detect active SARS-CoV-2 infection.
T209 20262-20384 Sentence denotes As the pandemic evolves, more and more insights will be gained in the value of serology as well as antigen detection [23].
T210 20385-20468 Sentence denotes The main limitation of the current study is the limited number of samples included.
T211 20469-20636 Sentence denotes Nevertheless, this study has evaluated the performance of 14 different serological assays and therefore could provide useful information in this stage of the pandemic.
T212 20637-20782 Sentence denotes In conclusion, our findings show that sensitivity was variable but increased in a later stage of infection (at least 8 days after symptom onset).
T213 20783-20875 Sentence denotes Interpretation of the combination of IgM or IgA and IgG resulted in the highest sensitivity.
T214 20876-21087 Sentence denotes Our data suggest that virus-specific antibody detection for SARS-CoV-2 can complement molecular testing for diagnosis of COVID-19, especially for patients presenting in the 2nd week or later after symptom onset.
T215 21088-21147 Sentence denotes Larger datasets should be used to confirm current findings.
T216 21149-21169 Sentence denotes Disclosure statement
T217 21170-21232 Sentence denotes No potential conflict of interest was reported by the authors.
T218 21234-21254 Sentence denotes Author contributions
T219 21255-21259 Sentence denotes VHE:
T220 21260-21357 Sentence denotes Conceptualization, Methodology, Investigation, Data Curation, Writing-Original draft preparation.
T221 21358-21387 Sentence denotes CL, BJ, VBE, BF, DBL, SP, WJ:
T222 21388-21418 Sentence denotes Writing-Reviewing and Editing.
T223 21419-21430 Sentence denotes VB, VS, PE:
T224 21431-21474 Sentence denotes Writing-Reviewing and Editing, Supervision.