anti sars cov 2 kuantitatif

WALTHAM Mass., (BUSINESS WIRE) -- EUROIMMUN, a PerkinElmer, Inc. company (NYSE: PKI), announced today that the U.S. Food and Drug Administration has AntiSARS-CoV-2 Kualitatif atau serology test COVID-19 mendeteksi antibodi terhadap protein Nucleocapsid (N), sedangkan pemeriksaan Anti SARS-CoV-2 Kuantitatif mendeteksi antibodi terhadap protein Spike-RBD. Antibodi terhadap protein Spike-RBD ini lah yang diketahui memiliki daya netralisasi terhadap virus SARS-CoV-2 penyebab COVID-19. COVID19 (Coronavirus Disease 19) adalah penyakit menular yang disebabkan oleh SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2), yaitu jenis coronavirus yang ditemukan di Wuhan, Cina, pada Desember 2019. Jadi COVID-19 adalah nama penyakitnya dan SARS-CoV-2 adalah nama virus yang menyebabkan penyakit tersebut. Thisis the first comprehensive overview of the application of compounds from A. annua against SARS-CoV-2/coronavirus disease 2019 (COVID-19) describing all target proteins. A. annua's biological properties, the signaling pathways implicated in the COVID-19, and the advantages and disadvantages for repurposing A. annua compounds are discussed. Paketini terdiri dari 3 pemeriksaan yaitu D-Dimer, Vit-D-25-OH, Anti SARS Cov 2/ Serologi Kuantitatif. Apa kegunaan dari masing-masing pemeriksaan pada Paket Pemeriksaan Pasca Covid? D-Dimer D-Dimer adalah pemeriksaan laboratorium yang memberikan gambaran ada atau tidaknya penggumpalan di dalam darah. Dengan mengetahui angka D-Dimer, tenaga Site De Rencontre Marocain Pour Mariage. . 2021 Dec;93126813-6817. doi Epub 2021 Aug 5. Affiliations PMID 34314037 PMCID PMC8427121 DOI Free PMC article The dynamics of quantitative SARS-CoV-2 antispike IgG response to BNT162b2 vaccination Shun Kaneko et al. J Med Virol. 2021 Dec. Free PMC article Abstract Vaccination for SARS-CoV-2 is necessary to overcome coronavirus disease 2019 COVID-19. However, the time-dependent vaccine-induced immune response is not well understood. This study aimed to investigate the dynamics of SARS-CoV-2 antispike immunoglobulin G IgG response. Medical staff participants who received two sequential doses of the BNT162b2 vaccination on days 0 and 21 were recruited prospectively from the Musashino Red Cross Hospital between March and May 2021. The quantitative antispike receptor-binding domain RBD IgG antibody responses were measured using the Abbott SARS-CoV-2 IgGII Quant assay cut off ≥50 AU/ml. A total of 59 participants without past COVID-19 history were continuously tracked with serum samples. The median age was 41 22-75 years, and 14 participants were male The median antispike RBD IgG and seropositivity rates were 0 AU/ml, AU/ml, AU/ml, 18, AU/ml, and 0%, 0%, and 100% on days 0, 3, 14, and 28 after the first vaccination, respectively. The antispike RBD IgG levels were significantly increased after day 14 from vaccination p < The BNT162b2 vaccination led almost all participants to obtain serum antispike RBD IgG 14 days after the first dose. Keywords COVID-19; SARS-Cov-2; mRNA vaccine; quantitative antispike RBD IgG. © 2021 Wiley Periodicals LLC. Conflict of interest statement The authors declare that there are no conflict of interests. Figures Figure 1 Dynamics of SARS‐CoV‐2 antispike RBD IgG response after vaccination. A Schema of the schedule for vaccination and blood test. B Antispike RBD IgG titer AU/ml and seropositive rate of antispike RBD IgG and antinucleocapsid IgG in a time‐dependent manner. RBD, receptor‐binding domain Similar articles Evaluation of Humoral Immune Response after SARS-CoV-2 Vaccination Using Two Binding Antibody Assays and a Neutralizing Antibody Assay. Nam M, Seo JD, Moon HW, Kim H, Hur M, Yun YM. Nam M, et al. Microbiol Spectr. 2021 Dec 22;93e0120221. doi Epub 2021 Nov 24. Microbiol Spectr. 2021. PMID 34817223 Free PMC article. Healthcare Workers in South Korea Maintain a SARS-CoV-2 Antibody Response Six Months After Receiving a Second Dose of the BNT162b2 mRNA Vaccine. Choi JH, Kim YR, Heo ST, Oh H, Kim M, Lee HR, Yoo JR. Choi JH, et al. Front Immunol. 2022 Jan 31;13827306. doi eCollection 2022. Front Immunol. 2022. PMID 35173736 Free PMC article. Evaluation of Seropositivity Following BNT162b2 Messenger RNA Vaccination for SARS-CoV-2 in Patients Undergoing Treatment for Cancer. Massarweh A, Eliakim-Raz N, Stemmer A, Levy-Barda A, Yust-Katz S, Zer A, Benouaich-Amiel A, Ben-Zvi H, Moskovits N, Brenner B, Bishara J, Yahav D, Tadmor B, Zaks T, Stemmer SM. Massarweh A, et al. JAMA Oncol. 2021 Aug 1;781133-1140. doi JAMA Oncol. 2021. PMID 34047765 Free PMC article. Evaluation of the SARS-CoV-2 Antibody Response to the BNT162b2 Vaccine in Patients Undergoing Hemodialysis. Yau K, Abe KT, Naimark D, Oliver MJ, Perl J, Leis JA, Bolotin S, Tran V, Mullin SI, Shadowitz E, Gonzalez A, Sukovic T, Garnham-Takaoka J, de Launay KQ, Takaoka A, Straus SE, McGeer AJ, Chan CT, Colwill K, Gingras AC, Hladunewich MA. Yau K, et al. JAMA Netw Open. 2021 Sep 1;49e2123622. doi JAMA Netw Open. 2021. PMID 34473256 Free PMC article. Review of SARS-CoV-2 Antigen and Antibody Testing in Diagnosis and Community Surveillance. Nerenz RD, Hubbard JA, Cervinski MA. Nerenz RD, et al. Clin Lab Med. 2022 Dec;424687-704. doi Clin Lab Med. 2022. PMID 36368790 Free PMC article. Review. No abstract available. Cited by Higher Immunological Response after BNT162b2 Vaccination among COVID-19 Convalescents-The Data from the Study among Healthcare Workers in an Infectious Diseases Center. Skrzat-Klapaczyńska A, Kowalska JD, Paciorek M, Puła J, Bieńkowski C, Krogulec D, Stengiel J, Pawełczyk A, Perlejewski K, Osuch S, Radkowski M, Horban A. Skrzat-Klapaczyńska A, et al. Vaccines Basel. 2022 Dec 15;10122158. doi Vaccines Basel. 2022. PMID 36560567 Free PMC article. Measurements of Anti-SARS-CoV-2 Antibody Levels after Vaccination Using a SH-SAW Biosensor. Cheng CH, Peng YC, Lin SM, Yatsuda H, Liu SH, Liu SJ, Kuo CY, Wang RYL. Cheng CH, et al. Biosensors Basel. 2022 Aug 4;128599. doi Biosensors Basel. 2022. PMID 36004995 Free PMC article. Relationship between changes in symptoms and antibody titers after a single vaccination in patients with Long COVID. Tsuchida T, Hirose M, Inoue Y, Kunishima H, Otsubo T, Matsuda T. Tsuchida T, et al. J Med Virol. 2022 Jul;9473416-3420. doi Epub 2022 Mar 8. J Med Virol. 2022. PMID 35238053 Free PMC article. The Comparability of Anti-Spike SARS-CoV-2 Antibody Tests is Time-Dependent a Prospective Observational Study. Perkmann T, Mucher P, Perkmann-Nagele N, Radakovics A, Repl M, Koller T, Schmetterer KG, Bigenzahn JW, Leitner F, Jordakieva G, Wagner OF, Binder CJ, Haslacher H. Perkmann T, et al. Microbiol Spectr. 2022 Feb 23;101e0140221. doi Epub 2022 Feb 23. Microbiol Spectr. 2022. PMID 35196824 Free PMC article. References Guan WJ, Ni ZY, Hu Y, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. 2020;382181708‐1720. - PMC - PubMed Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID‐19 in Wuhan, China a retrospective cohort study. Lancet. 2020;395102291054‐1062. - PMC - PubMed Zheng Z, Peng F, Xu B, et al. Risk factors of critical & mortal COVID‐19 cases a systematic literature review and meta‐analysis. J Infect. 2020;8116. - PMC - PubMed Hu Y, Sun J, Dai Z, et al. Prevalence and severity of corona virus disease 2019 COVID‐19 a systematic review and meta‐analysis. J Clin Virol. 2020;127104371. - PMC - PubMed World Health Organization . Coronavirus disease COVID‐19. Situation report. Accessed, May 17th, MeSH terms Substances LinkOut - more resources Full Text Sources Europe PubMed Central Ovid Technologies, Inc. PubMed Central Wiley Medical Genetic Alliance MedlinePlus Health Information Miscellaneous NCI CPTAC Assay Portal . 2021 Mar 19;594e03149-20. doi Print 2021 Mar 19. Affiliations PMID 33483360 PMCID PMC8092751 DOI Free PMC article Quantitative Measurement of Anti-SARS-CoV-2 Antibodies Analytical and Clinical Evaluation Victoria Higgins et al. J Clin Microbiol. 2021. Free PMC article Abstract The severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 is the causative agent of coronavirus disease 2019 COVID-19. Molecular-based testing is used to diagnose COVID-19, and serologic testing of antibodies specific to SARS-CoV-2 is used to detect past infection. While most serologic assays are qualitative, a quantitative serologic assay was recently developed that measures antibodies against the S protein, the target of vaccines. Quantitative antibody determination may help determine antibody titer and facilitate longitudinal monitoring of the antibody response, including antibody response to vaccines. We evaluated the quantitative Roche Elecsys anti-SARS-CoV-2 S assay. Specimens from 167 PCR-positive patients and 103 control specimens were analyzed using the Elecsys anti-SARS-CoV-2 S assay on the cobas e411 Roche Diagnostics. Analytical evaluation included assessing linearity, imprecision, and analytical sensitivity. Clinical evaluation included assessing clinical sensitivity, specificity, cross-reactivity, positive predictive value PPV, negative predictive value NPV, and serial sampling from the same patient. The Elecsys anti-SARS-CoV-2 S assay exhibited its highest sensitivity at 15 to 30 days post-PCR positivity and exhibited no cross-reactivity, a specificity and PPV of 100%, and an NPV between and at ≥14 days post-PCR positivity, depending on the seroprevalence estimate. Imprecision was 30, 0 to 14, and ≥14 days post-PCR positivity for the quantitative Roche Elecsys anti-SARS-CoV-2 S assay using serum or plasma samples collected from 167 patients confirmed SARS-CoV-2 positive within the previous 0 to 73 days. FIG 2 Anti-SARS-CoV-2 antibody response by days post-PCR positivity in five patients as measured by the quantitative Roche Elecsys anti-SARS-CoV-2 S assay. Similar articles Anti-SARS-CoV-2 IgM improves clinical sensitivity early in disease course. Higgins V, Fabros A, Wang XY, Bhandari M, Daghfal DJ, Kulasingam V. Higgins V, et al. Clin Biochem. 2021 Apr;901-7. doi Epub 2021 Jan 19. Clin Biochem. 2021. PMID 33476578 Free PMC article. Analytical and Clinical Evaluation of the Automated Elecsys Anti-SARS-CoV-2 Antibody Assay on the Roche cobas e602 Analyzer. Chan CW, Parker K, Tesic V, Baldwin A, Tang NY, van Wijk XMR, Yeo KJ. Chan CW, et al. Am J Clin Pathol. 2020 Oct 13;1545620-626. doi Am J Clin Pathol. 2020. PMID 32814955 Free PMC article. Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays. Merrill AE, Jackson JB, Ehlers A, Voss D, Krasowski MD. Merrill AE, et al. J Appl Lab Med. 2020 Nov 1;561351-1357. doi J Appl Lab Med. 2020. PMID 32717056 Free PMC article. [SARS-CoV-2 and Microbiological Diagnostic Dynamics in COVID-19 Pandemic]. Erensoy S. Erensoy S. Mikrobiyol Bul. 2020 Jul;543497-509. doi Mikrobiyol Bul. 2020. PMID 32755524 Review. Turkish. Performance of Elecsys Anti-SARS CoV-2 Roche and VIDAS Anti-SARS CoV-2 Biomérieux for SARS-CoV-2 Nucleocapsid and Spike Protein Antibody Detection. Inés RM, Gabriela HTM, Paula CM, Magdalena TM, Jimena A, Salome KB, Javier AJ, Sebastián B, Lorena S, Adrián DL, Elisa R, Mauricio B, Tersita BM, Verónica GS, Beatriz IM. Inés RM, et al. EJIFCC. 2022 Aug 8;332159-165. eCollection 2022 Aug. EJIFCC. 2022. PMID 36313907 Free PMC article. Review. Cited by Association between reactogenicity and immunogenicity after BNT162b2 booster vaccination a secondary analysis of a prospective cohort study. Jorda A, Bergmann F, Ristl R, Radner H, Sieghart D, Aletaha D, Zeitlinger M. Jorda A, et al. Clin Microbiol Infect. 2023 May 25S1198-743X2300252-5. doi Online ahead of print. Clin Microbiol Infect. 2023. PMID 37244466 Free PMC article. Variation in antibody titers determined by Abbott and Roche Elecsys SARS-CoV-2 assays in vaccinated healthcare workers. Nakai M, Yokoyama D, Sato T, Sato R, Kojima C, Shimosawa T. Nakai M, et al. Heliyon. 2023 Jun;96e16547. doi Epub 2023 May 22. Heliyon. 2023. PMID 37235203 Free PMC article. Anti-N SARS-CoV-2 assays for evaluation of natural viral infection. Gaeta A, Angeloni A, Napoli A, Pucci B, Cinti L, Roberto P, Colaiacovo F, Berardelli E, Farina A, Antonelli G, Anastasi E. Gaeta A, et al. J Immunol Methods. 2023 Jul;518113486. doi Epub 2023 May 6. J Immunol Methods. 2023. PMID 37156408 Free PMC article. Humoral Immune Response Following SARS-CoV-2 mRNA Vaccination and Infection in Pediatric-Onset Multiple Sclerosis. Breu M, Lechner C, Schneider L, Tobudic S, Winkler S, Siegert S, Baumann M, Seidl R, Berger T, Kornek B. Breu M, et al. Pediatr Neurol. 2023 Jun;14319-25. doi Epub 2023 Mar 2. Pediatr Neurol. 2023. PMID 36966598 Free PMC article. SARS-CoV-2-reactive antibody waning, booster effect and breakthrough SARS-CoV-2 infection in hematopoietic stem cell transplant and cell therapy recipients at one year after vaccination. Piñana JL, Martino R, Vazquez L, López-Corral L, Pérez A, Chorão P, Avendaño-Pita A, Pascual MJ, Sánchez-Salinas A, Sanz-Linares G, Olave MT, Arroyo I, Tormo M, Villalon L, Conesa-Garcia V, Gago B, Terol MJ, Villalba M, Garcia-Gutierrez V, Cabero A, Hernández-Rivas JÁ, Ferrer E, García-Cadenas I, Teruel A, Navarro D, Cedillo Á, Sureda A, Solano C; Spanish Hematopoietic Stem Cell Transplantation and Cell Therapy Group GETH-TC. Piñana JL, et al. Bone Marrow Transplant. 2023 May;585567-580. doi Epub 2023 Feb 28. Bone Marrow Transplant. 2023. PMID 36854892 Free PMC article. References Carter LJ, Garner LV, Smoot JW, Li Y, Zhou Q, Saveson CJ, Sasso JM, Gregg AC, Soares DJ, Beskid TR, Jervey SR, Liu C. 2020. Assay techniques and test development for COVID-19 diagnosis. ACS Cent Sci 6591–605. doi - DOI - PMC - PubMed Van Caeseele P, Bailey D, Forgie SE, Dingle TC, Krajden M, COVID-19 Immunity Task Force. 2020. SARS-CoV-2 COVID-19 serology implications for clinical practice, laboratory medicine and public health. CMAJ 192E973–E979. doi - DOI - PMC - PubMed Deeks JJ, Dinnes J, Takwoingi Y, Davenport C, Spijker R, Taylor-Phillips S, Adriano A, Beese S, Dretzke J, Ferrante di Ruffano L, Harris IM, Price MJ, Dittrich S, Emperador D, Hooft L, Leeflang MM, Van den Bruel A, Cochrane COVID-19 Diagnostic Test Accuracy Group. 2020. Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev 6CD013652. doi - DOI - PMC - PubMed Long Q-X, Liu B-Z, Deng H-J, Wu G-C, Deng K, Chen Y-K, Liao P, Qiu J-F, Lin Y, Cai X-F, Wang D-Q, Hu Y, Ren J-H, Tang N, Xu Y-Y, Yu L-H, Mo Z, Gong F, Zhang X-L, Tian W-G, Hu L, Zhang X-X, Xiang J-L, Du H-X, Liu H-W, Lang C-H, Luo X-H, Wu S-B, Cui X-P, Zhou Z, Zhu M-M, Wang J, Xue C-J, Li X-F, Wang L, Li Z-J, Wang K, Niu C-C, Yang Q-J, Tang X-J, Zhang Y, Liu X-M, Li J-J, Zhang D-C, Zhang F, Liu P, Yuan J, Li Q, Hu J-L, Chen J, et al. 2020. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med 26845–848. doi - DOI - PubMed Kofler N, Baylis F. 2020. Ten reasons why immunity passports are a bad idea. Nature 581379–381. doi - DOI - PubMed MeSH terms Substances LinkOut - more resources Full Text Sources Atypon Europe PubMed Central PubMed Central Other Literature Sources scite Smart Citations Medical Genetic Alliance MedlinePlus Health Information Miscellaneous NCI CPTAC Assay Portal Brief Communication Published 29 April 2020 Bai-Zhong Liu2 na1, Hai-Jun Deng ORCID na1, Gui-Cheng Wu3,4 na1, Kun Deng5 na1, Yao-Kai Chen6 na1, Pu Liao7, Jing-Fu Qiu8, Yong Lin ORCID Xue-Fei Cai1, De-Qiang Wang1, Yuan Hu1, Ji-Hua Ren1, Ni Tang1, Yin-Yin Xu2, Li-Hua Yu2, Zhan Mo2, Fang Gong2, Xiao-Li Zhang2, Wen-Guang Tian2, Li Hu2, Xian-Xiang Zhang3,4, Jiang-Lin Xiang3,4, Hong-Xin Du3,4, Hua-Wen Liu3,4, Chun-Hui Lang3,4, Xiao-He Luo3,4, Shao-Bo Wu3,4, Xiao-Ping Cui3,4, Zheng Zhou3,4, Man-Man Zhu5, Jing Wang6, Cheng-Jun Xue6, Xiao-Feng Li6, Li Wang6, Zhi-Jie Li7, Kun Wang7, Chang-Chun Niu7, Qing-Jun Yang7, Xiao-Jun Tang8, Yong Zhang ORCID Xia-Mao Liu9, Jin-Jing Li9, De-Chun Zhang10, Fan Zhang10, Ping Liu11, Jun Yuan1, Qin Li12, Jie-Li Hu ORCID Juan Chen ORCID & …Ai-Long Huang ORCID Nature Medicine volume 26, pages 845–848 2020Cite this article 824k Accesses 5536 Citations 4038 Altmetric Metrics details Subjects AbstractWe report acute antibody responses to SARS-CoV-2 in 285 patients with COVID-19. Within 19 days after symptom onset, 100% of patients tested positive for antiviral immunoglobulin-G IgG. Seroconversion for IgG and IgM occurred simultaneously or sequentially. Both IgG and IgM titers plateaued within 6 days after seroconversion. Serological testing may be helpful for the diagnosis of suspected patients with negative RT–PCR results and for the identification of asymptomatic infections. MainThe continued spread of coronavirus disease 2019 COVID-19 has prompted widespread concern around the world, and the World Health Organization WHO, on 11 March 2020, declared COVID-19 a pandemic. Studies on severe acute respiratory syndrome SARS and Middle East respiratory syndrome MERS showed that virus-specific antibodies were detectable in 80–100% of patients at 2 weeks after symptom onset1,2,3,4,5,6. Currently, the antibody responses against SARS-CoV-2 remain poorly understood and the clinical utility of serological testing is total of 285 patients with COVID-19 were enrolled in this study from three designated hospitals; of these patients, 70 had sequential samples available. The characteristics of these patients are summarized in Supplementary Tables 1 and 2. We validated and used a magnetic chemiluminescence enzyme immunoassay MCLIA for virus-specific antibody detection Extended Data Fig. 1a–d and Supplementary Table 3. Serum samples from patients with COVID-19 showed no cross-binding to the S1 subunit of the SARS-CoV spike antigen. However, we did observe some cross-reactivity of serum samples from patients with COVID-19 to nucleocapsid antigens of SARS-CoV Extended Data Fig. 1e. The proportion of patients with positive virus-specific IgG reached 100% approximately 17–19 days after symptom onset, while the proportion of patients with positive virus-specific IgM reached a peak of approximately 20–22 days after symptom onset Fig. 1a and Methods. During the first 3 weeks after symptom onset, there were increases in virus-specific IgG and IgM antibody titers Fig. 1b. However, IgM showed a slight decrease in the >3-week group compared to the ≤3-week group Fig. 1b. IgG and IgM titers in the severe group were higher than those in the non-severe group, although a significant difference was only observed in IgG titer in the 2-week post-symptom onset group Fig. 1c, P = 1 Antibody responses against Graph of positive rates of virus-specific IgG and IgM versus days after symptom onset in 363 serum samples from 262 patients. b, Levels of antibodies against SARS-CoV-2 in patients at different times after symptom onset. c, Comparison of the level of antibodies against SARS-CoV-2 between severe and non-severe patients. The boxplots in b and c show medians middle line and third and first quartiles boxes, while the whiskers show the interquartile range IQR above and below the box. Numbers of patients N are shown underneath. P values were determined with unpaired, two-sided Mann–Whitney DataFull size imageSixty-three patients with confirmed COVID-19 were followed up until discharge. Serum samples were collected at 3-day intervals. Among these, the overall seroconversion rate was 61/63 over the follow-up period. Two patients, a mother and daughter, maintained IgG- and IgM-negative status during hospitalization. Serological courses could be followed for 26 patients who were initially seronegative and then underwent seroconversion during the observation period. All these patients achieved seroconversion of IgG or IgM within 20 days after symptom onset. The median day of seroconversion for both IgG and IgM was 13 days post symptom onset. Three types of seroconversion were observed synchronous seroconversion of IgG and IgM nine patients, IgM seroconversion earlier than that of IgG seven patients and IgM seroconversion later than that of IgG ten patients Fig. 2a. Longitudinal antibody changes in six representative patients of the three types of seroconversion are shown in Fig. 2b–d and Extended Data Fig. 2a– 2 Seroconversion time of the antibodies against Seroconversion type of 26 patients who were initially seronegative during the observation period. The days of seroconversion for each patient are plotted. b–d, Six representative examples of the three seroconversion type synchronous seroconversion of IgG and IgM b, IgM seroconversion earlier than that of IgG c and IgM seroconversion later than that of IgG c.Full size imageIgG levels in the 19 patients who underwent IgG seroconversion during hospitalization plateaued 6 days after the first positive IgG measurement Extended Data Fig. 3. Plateau IgG levels varied widely more than 20-fold across patients. IgM also showed a similar profile of dynamic changes Extended Data Fig. 4. We found no association between plateau IgG levels and the clinical characteristics of the patients Extended Data Fig. 5a–d. We next analyzed whether the criteria for confirmation of MERS-CoV infection recommended by WHO, including 1 seroconversion or 2 a fourfold increase in IgG-specific antibody titers, are suitable for the diagnosis of COVID-19 using paired samples from 41 patients. The initial sample was collected in the first week of illness and the second was collected 2–3 weeks later. Of the patients whose IgG was initially seronegative in the first week of illness, 21/41 underwent seroconversion. A total of 18 patients were initially seropositive in the first week of illness; of these, eight patients had a fourfold increase in virus-specific IgG titers Extended Data Fig. 6. Overall, 29/41 of the patients with COVID-19 met the criteria of IgG seroconversion and/or fourfold increase or greater in the IgG investigate whether serology testing could help identify patients with COVID-19, we screened 52 suspected cases in patients who displayed symptoms of COVID-19 or abnormal radiological findings and for whom testing for viral RNA was negative in at least two sequential samples. Of the 52 suspected cases, four had virus-specific IgG or IgM in the initial samples Extended Data Fig. 7. Patient 3 had a greater than fourfold increase in IgG titer 3 days after the initial serology testing. Interestingly, patient 3 also tested positive for viral infection by polymerase chain reaction with reverse transcription RT–PCR between the two antibody measurements. IgM titer increased over three sequential samples from patient 1 1 was defined as positive and S/CO ≤ 1 as of IgG and IgM against SARS-CoV-2To measure the level of IgG and IgM against SARS-CoV-2, serum samples were collected from the patients. All serum samples were inactivated at 56 °C for 30 min and stored at −20 °C before testing. IgG and IgM against SARS-CoV-2 in plasma samples were tested using MCLIA kits supplied by Bioscience Co. approved by the China National Medical Products Administration; approval numbers 20203400183IgG and 20203400182IgM, according to the manufacturer’s instructions. MCLIA for IgG or IgM detection was developed based on a double-antibody sandwich immunoassay. The recombinant antigens containing the nucleoprotein and a peptide from the spike protein of SARS-CoV-2 were conjugated with FITC and immobilized on anti-FITC antibody-conjugated magnetic particles. Alkaline phosphatase conjugated anti-human IgG/IgM antibody was used as the detection antibody. The tests were conducted on an automated magnetic chemiluminescence analyzer Axceed 260, Bioscience according to the manufacturer’s instructions. All tests were performed under strict biosafety conditions. The antibody titer was tested once per serum sample. Antibody levels are presented as the measured chemiluminescence values divided by the cutoff S/CO. The cutoff value of this test was defined by receiver operating characteristic curves. Antibody levels in the figures were calculated as log2S/CO + 1.Performance evaluation of the SARS-CoV-2-specific IgG/IgM detection assayThe precision and reproducibility of the MCLIA kits were first evaluated by the National Institutes for Food and Drug Control. Moreover, 30 serum samples from patients with COVID-19 showing different titers of IgG range and IgM range were tested. Each individual sample was tested in three independent experiments, and the coefficient of variation CV was used to evaluate the precision of the assay. Finally, 46 serum samples from patients with COVID-19 were assessed using different batches of the diagnostic kit for SARS-CoV-2-specific IgG or IgM antibody; reproducibility was calculated based on the results from two batch of antigens from SARS-CoV and SARS-CoV-2Two recombinant SARS-CoV nucleocapsid N proteins from two different sources Sino Biological, cat. no. 40143-V08B; Biorbyt, cat. no. orb82478, the recombinant S1 subunit of the SARS-CoV spike Sino Biological, cat. no. 40150-V08B1 and the homemade recombinant N protein of SARS-CoV-2 were used in a chemiluminescence enzyme immunoassay CLEIA, respectively. The concentration of antigens used for plate coating was μg ml−1. The dilution of alkaline phosphatase conjugated goat anti-human IgG antibody was 12,500. Five serum samples from patients with COVID-19 and five serum samples from healthy controls were diluted 150 and tested using CLEIA assays. The binding ability of antibody to antigen in a sample was measured in relative luminescence analysesContinuous variables are expressed as the median IQR and were compared with the Mann–Whitney U-test. Categorical variables are expressed as numbers % and were compared by Fisher’s exact test. A P value of < was considered statistically significant. Statistical analyses were performed using R software, version approvalThe study was approved by the Ethics Commission of Chongqing Medical University ref. no. 2020003. Written informed consent was waived by the Ethics Commission of the designated hospital for emerging infectious SummaryFurther information on research design is available in the Nature Research Reporting Summary linked to this article. Data availabilityRaw data in this study are provided in the Supplementary Dataset. Additional supporting data are available from the corresponding authors on request. 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This work was supported by the Emergency Project from the Science & Technology Commission of Chongqing and a Major National S&T Program grant 2017ZX10202203 and 2017ZX10302201 from the Science & Technology Commission of informationAuthor notesThese authors contributed equally Quan-Xin Long, Bai-Zhong Liu, Hai-Jun Deng, Gui-Cheng Wu, Kun Deng, Yao-Kai and AffiliationsKey Laboratory of Molecular Biology on Infectious Diseases, Ministry of Education, Chongqing Medical University, Chongqing, ChinaQuan-Xin Long, Hai-Jun Deng, Yong Lin, Xue-Fei Cai, De-Qiang Wang, Yuan Hu, Ji-Hua Ren, Ni Tang, Jun Yuan, Jie-Li Hu, Juan Chen & Ai-Long HuangYongchuan Hospital Affiliated to Chongqing Medical University, Chongqing, ChinaBai-Zhong Liu, Yin-Yin Xu, Li-Hua Yu, Zhan Mo, Fang Gong, Xiao-Li Zhang, Wen-Guang Tian & Li HuChongqing University Three Gorges Hospital, Chongqing, ChinaGui-Cheng Wu, Xian-Xiang Zhang, Jiang-Lin Xiang, Hong-Xin Du, Hua-Wen Liu, Chun-Hui Lang, Xiao-He Luo, Shao-Bo Wu, Xiao-Ping Cui & Zheng ZhouChongqing Three Gorges Central Hospital, Chongqing, ChinaGui-Cheng Wu, Xian-Xiang Zhang, Jiang-Lin Xiang, Hong-Xin Du, Hua-Wen Liu, Chun-Hui Lang, Xiao-He Luo, Shao-Bo Wu, Xiao-Ping Cui & Zheng ZhouThe Third Hospital Affiliated to Chongqing Medical University, Chongqing, ChinaKun Deng & Man-Man ZhuDivision of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, ChinaYao-Kai Chen, Jing Wang, Cheng-Jun Xue, Xiao-Feng Li & Li WangLaboratory Department, Chongqing People’s Hospital, Chongqing, ChinaPu Liao, Zhi-Jie Li, Kun Wang, Chang-Chun Niu & Qing-Jun YangSchool of Public Health and Management, Chongqing Medical University, Chongqing, ChinaJing-Fu Qiu, Xiao-Jun Tang & Yong ZhangThe Second Affiliated Hospital of Chongqing Medical University, Chongqing, ChinaXia-Mao Liu & Jin-Jing LiWanzhou People’s Hospital, Chongqing, ChinaDe-Chun Zhang & Fan ZhangBioScience Co. Ltd, Chongqing, ChinaPing LiuChongqing Center for Disease Control and Prevention, Chongqing, ChinaQin LiAuthorsQuan-Xin LongYou can also search for this author in PubMed Google ScholarBai-Zhong LiuYou can also search for this author in PubMed Google ScholarHai-Jun DengYou can also search for this author in PubMed Google ScholarGui-Cheng WuYou can also search for this author in PubMed Google ScholarKun DengYou can also search for this author in PubMed Google ScholarYao-Kai ChenYou can also search for this author in PubMed Google ScholarPu LiaoYou can also search for this author in PubMed Google ScholarJing-Fu QiuYou can also search for this author in PubMed Google ScholarYong LinYou can also search for this author in PubMed Google ScholarXue-Fei CaiYou can also search for this author in PubMed Google ScholarDe-Qiang WangYou can also search for this author in PubMed Google ScholarYuan HuYou can also search for this author in PubMed Google ScholarJi-Hua RenYou can also search for this author in PubMed Google ScholarNi TangYou can also search for this author in PubMed Google ScholarYin-Yin XuYou can also search for this author in PubMed Google ScholarLi-Hua YuYou can also search for this author in PubMed Google ScholarZhan MoYou can also search for this author in PubMed Google ScholarFang GongYou can also search for this author in PubMed Google ScholarXiao-Li ZhangYou can also search for this author in PubMed Google ScholarWen-Guang TianYou can also search for this author in PubMed Google ScholarLi HuYou can also search for this author in PubMed Google ScholarXian-Xiang ZhangYou can also search for this author in PubMed Google ScholarJiang-Lin XiangYou can also search for this author in PubMed Google ScholarHong-Xin DuYou can also search for this author in PubMed Google ScholarHua-Wen LiuYou can also search for this author in PubMed Google ScholarChun-Hui LangYou can also search for this author in PubMed Google ScholarXiao-He LuoYou can also search for this author in PubMed Google ScholarShao-Bo WuYou can also search for this author in PubMed Google ScholarXiao-Ping CuiYou can also search for this author in PubMed Google ScholarZheng ZhouYou can also search for this author in PubMed Google ScholarMan-Man ZhuYou can also search for this author in PubMed Google ScholarJing WangYou can also search for this author in PubMed Google ScholarCheng-Jun XueYou can also search for this author in PubMed Google ScholarXiao-Feng LiYou can also search for this author in PubMed Google ScholarLi WangYou can also search for this author in PubMed Google ScholarZhi-Jie LiYou can also search for this author in PubMed Google ScholarKun WangYou can also search for this author in PubMed Google ScholarChang-Chun NiuYou can also search for this author in PubMed Google ScholarQing-Jun YangYou can also search for this author in PubMed Google ScholarXiao-Jun TangYou can also search for this author in PubMed Google ScholarYong ZhangYou can also search for this author in PubMed Google ScholarXia-Mao LiuYou can also search for this author in PubMed Google ScholarJin-Jing LiYou can also search for this author in PubMed Google ScholarDe-Chun ZhangYou can also search for this author in PubMed Google ScholarFan ZhangYou can also search for this author in PubMed Google ScholarPing LiuYou can also search for this author in PubMed Google ScholarJun YuanYou can also search for this author in PubMed Google ScholarQin LiYou can also search for this author in PubMed Google ScholarJie-Li HuYou can also search for this author in PubMed Google ScholarJuan ChenYou can also search for this author in PubMed Google ScholarAi-Long HuangYou can also search for this author in PubMed Google ScholarContributionsConceptualization was provided by The methodology was developed by P. Liu, and Investigations were carried out by and The original draft of the manuscript was written by and Review and editing of the manuscript were carried out by and Funding acquisition was performed by and Resources were provided by P. Liao, . and provided authorsCorrespondence to Jie-Li Hu, Juan Chen or Ai-Long declarations Competing interests The authors declare no competing interests. Additional informationPeer review information Saheli Sadanand was the primary editor on this article and managed its editorial process and peer review in collaboration with the rest of the editorial note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional dataExtended Data Fig. 1 The performance evaluation of the SARS-CoV-2 specific IgG/IgM detection Thirty serum sample from COVID-19 patients showing different titers of IgG a range from to and IgM b range from to were tested. Each individual sample was tested in three independent experiment. CVs of titers of certain sample were calculated and presented. c,d. The correlation analysis of IgG and IgM titers serum samples from COVID-19 patients from 2 independent experiment. Forty-six serum samples from COVID-19 patients were detected using different batches of diagnostic kit for SARS-CoV-2 IgG c or IgM d antibody. Pearson correlation coefficients R are depicted in plots. For IgG, r = p = For IgM, r = p = e. The reactivity between COVID-19 patient serums N = 5 and SARS-CoV S1, N two sources and SARS-CoV-2 N protein were measured by ELISA. Serum samples from COVID-19 patients showed no cross-binding to SARS-CoV S1 antigen, while the reactivity between COVID-19 patient serums and SARS-CoV N antigen from different sources was inconsistent. Source Data Extended Data Fig. 2 Three types of Patients with a synchronous seroconversion of IgG and IgM N = 7. b. Seroconversion for IgG occurred later than that for IgMN = 5. c. Seroconversion for IgG occurred earlier than that for IgM N = 8.Extended Data Fig. 3 Dynamic changes of the SARS-CoV-2 specific course of the virus-specific IgG level in 19 patients experienced IgG titer plateau. IgG in each patient reached plateau within 6 days since IgG became Data Fig. 4 Dynamic changes of the SARS-CoV-2 specific course of the virus-specific IgM level in 20 patients experienced IgM titer plateau. IgM in each patient reached plateau within 6 days since IgM became Data Fig. 5 The association between the IgG levels at the plateau and clinical characteristics of the COVID-19 No significant difference in the IgG levels at the plateau was found between < 60 y group N = 11 and ≥ 60 y group N = 9. Unpaired, two-sided Mann-Whitney U test, p = b–d. No association was found between the IgG levels at the plateau and lymphocyte count b or CRP c or hospital stay d of the patients N = 20. Pearson correlation coefficients r and p value are depicted in plots. Source Data Extended Data Fig. 6 The assessment of MERS serological criteria for assessment of MERS serological criteria for COVID-19 confirmation were carried out in 41 patients with sequential samples. All 41 patients were classified into three groups based on IgG change from sequential samples, including 1 seroconversion, 2 fold change ≥ 4-fold in paired samples, 3 Data Fig. 7 Serology testing in identification of COVID-19 from 52 suspected of symptom onset, RT-PCR and serology testing in 4 cases developing positive IgG or/and IgM were Data Fig. 8 Serological survey in close contacts with COVID-19 cluster of 164 close contacts of known COVID-19 patients were tested by RT-PCR followed by serology testing. Serum samples were collected from these 164 individuals for antibody tests approximately 30 days after informationSource dataRights and permissionsAbout this articleCite this articleLong, QX., Liu, BZ., Deng, HJ. et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med 26, 845–848 2020. citationReceived 24 March 2020Accepted 22 April 2020Published 29 April 2020Issue Date June 2020DOI This article is cited by The development timeline of COVID-19 vaccines is unprecedented, with more than 300 vaccine developers active worldwide. Vaccine candidates developed with various technology platforms targeting different epitopes of SARS-CoV-2 are in the pipeline. Vaccine developers are using a range of immunoassays with different readouts to measure immune responses after vaccination, making comparisons of the immunogenicity of different COVID-19 vaccine candidates April, 2020, in a joint effort, the Coalition for Epidemic Preparedness Innovations CEPI, the National Institute for Biological Standards and Control NIBSC, and WHO provided vaccine developers and the entire scientific community with a research reagent for an anti-SARS-CoV-2 antibody. The availability of this material was crucial for facilitating the development of diagnostics, vaccines, and therapeutic preparations. This effort was an initial response when NIBSC, in its capacity as a WHO collaborating centre, was working on the preparation of the WHO International Standards. This work included a collaborative study that was launched in July, 2020, to test serum samples and plasma samples sourced from convalescent patients with the aim of selecting the most suitable candidate material for the WHO International Standards for anti-SARS-CoV-2 immunoglobulin. The study involved 44 laboratories from 15 countries and the use of live and pseudotype-based neutralisation assays, ELISA, rapid tests, and other methods. The outcomes of the study were submitted to WHO in November, 2020. The inter-laboratory variation was reduced more than 50 times for neutralisation and 2000 times for ELISA when assay values were reported relative to the International International Standard and International Reference Panel for anti-SARS-CoV-2 immunoglobulins were adopted by the WHO Expert Committee on Biological Standardization on Dec 10, WHO International Standard for anti-SARS-CoV-2 Scholar The International Standard allows the accurate calibration of assays to an arbitrary unit, thereby reducing inter-laboratory variation and creating a common language for reporting data. The International Standard is based on pooled human plasma from convalescent patients, which is lyophilised in ampoules, with an assigned unit of 250 international units IU per ampoule for neutralising activity. For binding assays, a unit of 1000 binding antibody units BAU per mL can be used to assist the comparison of assays detecting the same class of immunoglobulins with the same specificity eg, anti-receptor-binding domain IgG, anti-N IgM, etc The International Standard is available in the NIBSC have been launched for the harmonisation of immune response assessment across COVID-19 vaccine candidates, including the CEPI Global Centralised Laboratory for Epidemic Preparedness InnovationsCEPI establishes global network of laboratories to centralise assessment of COVID-19 vaccine Scholar CEPI centralised laboratories will achieve harmonisation of the results from different vaccine clinical trials with the use of common standard operating procedures and the same crucial reagents, including a working standard calibrated to the international basic tool for any harmonisation is the global use of an International Standard and IU to which assay data need to be calibrated with the use of a reliable method. It is therefore crucial that the International Standard is properly used by all vaccine developers, national reference laboratories, and academic groups worldwide, and that immunogenicity results are reported as an international standard unit IU/mL for neutralising antibodies and BAU/mL for binding assay formats.In this manner, the results from clinical trials expressed in IU would allow for the comparison of the immune responses after natural infection and induced by various vaccine candidates. This comparison is particularly important for the identification of correlates of protection against COVID-19; should neutralising antibodies be further supported as a component of the protective response, the expression of antibody responses in IU/mL is essential to gather a consensus from several clinical trials and other studies on the titre required for the correlate of protection against SARS-2-CoV has not yet been unequivocally defined, antibodies are likely to be at least part of the protective response. The effect of new variants on the evaluation of antibodies is obvious and unequivocal comparisons are required. Reporting the immunological responses from vaccine clinical trials against the International Standard is essential for the evaluation of clinical data submitted to national regulatory authorities as well as to WHO for emergency use listing, especially as placebo-controlled efficacy studies become operationally unfeasible. There will be a substantial effect on the use of the International Standard if regulatory authorities worldwide request data in IU/mL or BAU/mL. We also encourage journal editors and peer reviewers to ensure that the international standard is used as the benchmark in publications and that data from serology assays are reported in International Standard declare no competing TT Cramer JP Chen R Mayhew S Evolution of the COVID-19 vaccine development Rev Drug Discov. 2020; 19 WHO International Standard for anti-SARS-CoV-2 for Epidemic Preparedness InnovationsCEPI establishes global network of laboratories to centralise assessment of COVID-19 vaccine infoPublication historyPublished March 23, 2021IdentificationDOI Copyright © 2021 Published by Elsevier Ltd. All rights this article on ScienceDirectView Large ImageDownload Hi-res image Download .PPT

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