Clinical Study of MAGLUMI® 2019-nCoV IgM

Yuan J
Snibe Reagent Research & Development Center, Shenzhen, China

Background
The novel coronavirus (2019-nCoV, official name SARS-CoV-2), which belongs to the genus Beta-coronavirus, causes an epidemic of acute
respiratory syndrome in human population globally since December 2019 [1]. In February 2020, World Health Organization (WHO) announced the
official name of pneumonia caused by SARS-CoV-2 as "COVID-19", and acknowledged that COVID-19 had become a pandemic. With the
increasing COVID-19 cases, early diagnosis and early treatment to minimize the spread of the novel coronavirus has become a priority.
After human infection in 2019-nCoV, 2019-nCoV IgM appears earlier and becomes detectable around 3-5 days after onset, and then the
2019-nCoV IgG titers increase rapidly. 2019-nCoV reaches a titration of at least 4-fold increase during convalescence compared with the acute
phase [2].
MAGLUMI 2019-nCoV IgG and IgM can assist early detection of COVID-19 and reducing the false negative case of 2019-nCoV nucleic acid
assay, which can greatly improve the clinical detection rate.

Objectives
The aim of this study was to verify the clinical effectiveness of the MAGLUMI 2019-nCoV IgM by evaluating the clinical sensitivity and specificity.

Materials and Methods

Totally 289 serum samples (included 200 clinically confirmed negative and 89 clinically confirmed positive) were collected in China from Union
Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Shengjing Hospital of China Medical University,
The third people's Hospital of Wuhu City, Affiliated Hospital of Jiangsu University and Guangzhou Eighth People's Hospital.
Positive and negative of the serum samples were tested on Snibe MAGLUMI System with MAGLUMI 2019-nCoV IgG/IgM qualitative CLIA reagent
kits.

Clinical Study Result

There are 70 positive results tested by MAGLUMI 2019-nCoV IgM in 89 clinically confirmed positive samples. While in other 200 clinically
confirmed negative samples, 195 negative results via 2019-nCoV IgM.

Table 1 Clinical sensitivity, specificity and 95% confidence interval of MAGLUMI 2019-nCoV IgM
Study 1 Specimen Category 2019-nCoV IgM (CLIA)

No. Positive %Sensitivity 95% confidence interval

Clinical sensitivity Clinically Confirmed Positive Samples
89 70 78.65% 70.14%~87.16%
No. Negative %Specificity 95% confidence interval
Clinical specificity Negative Samples
200 195 97.50% 95.34%~99.66%
There are 80 positive results tested by joint detection of MAGLUMI 2019-nCoV IgM and IgG in 89 clinically confirmed positive samples. While in other
200 clinically confirmed negative samples, 193 negative results via joint detection of MAGLUMI 2019-nCoV IgM and IgG.
Table 2 Clinical sensitivity, specificity and 95% confidence interval of joint detection of MAGLUMI 2019-nCoV IgM and IgG
Study 2 Specimen Category 2019-nCoV IgM (CLIA)+2019-nCoV IgG (CLIA)

No. Positive %Sensitivity 95% confidence interval

Clinical sensitivity Clinically Confirmed Positive Samples
89 80 89.89% 83.62%~96.15%
No. Negative %Specificity 95% confidence interval
Clinical specificity Negative Samples
200 193 96.5% 93.95%~99.05%

Conclusion and Discussion

The clinical study showed that clinical sensitivity and specificity of MAGLUMI 2019-nCoV IgM is 78.65% and 97.50%. After joint detection of
MAGLUMI 2019-nCoV IgM and 2019-nCoV IgG, the clinical sensitivity and specificity of COVID-19 will improve to 89.89% and 96.50%. The
detection results indicate that MAGLUMI 2019-nCoV IgM and 2019-nCoV IgG have a good clinical value on assisting the diagnosis of COVID-19.
Thus, it is recommended to joint detect MAGLUMI 2019-nCoV IgM and 2019-nCoV IgG to improve the clinical detection rate of COVID-19.
The positive rate of IgG and IgM antibodies may be affected by the infection period of the test subject (when blood sampling) in different studies.

Reference
[1] Roujian Lu, Xiang Zhao, Juan Li, et al, Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. The Lancet. Volume
395, Issue 10224, 22–28 February 2020, Pages 565-574.
[2] Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7). Released by National Health Commission & State Administration of Traditional Chinese Medicine
on March 3, 2020
Clinical Study of MAGLUMI® 2019-nCoV IgG
Yuan J
Snibe Reagent Research & Development Center, Shenzhen, China
Background
The novel coronavirus (2019-nCoV, official name SARS-CoV-2), which belongs to the genus Beta-coronavirus, causes an epidemic of acute
respiratory syndrome in human population globally since December 2019 [1]. In February 2020, World Health Organization (WHO) announced the
official name of pneumonia caused by SARS-CoV-2 as "COVID-19", and acknowledged that COVID-19 had become a pandemic. With the
increasing COVID-19 cases, early diagnosis and early treatment to minimize the spread of the novel coronavirus has become a priority.
After human infection in 2019-nCoV, 2019-nCoV IgM appears earlier and becomes detectable around 3-5 days after onset, and then the
2019-nCoV IgG titers increase rapidly. 2019-nCoV reaches a titration of at least 4-fold increase during convalescence compared with the acute
phase [2].
MAGLUMI 2019-nCoV IgG and IgM can assist early detection of COVID-19 and reducing the false negative case of 2019-nCoV nucleic acid
assay, which can greatly improve the clinical detection rate.

Objectives
The aim of this study was to verify the clinical effectiveness of the MAGLUMI 2019-nCoV IgG by evaluating the clinical sensitivity and specificity.

Materials and Methods

Totally 841 serum samples (included 750 clinically confirmed negative and 91 clinically confirmed positive) were collected in China from Union
Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Guangzhou Eighth People's Hospital, Affiliated
Hospital of Jiangsu University and Guangzhou Eighth People's Hospital.
Positive and negative of the serum samples were tested on Snibe MAGLUMI System with MAGLUMI 2019-nCoV IgG/IgM qualitative CLIA reagent
kits.

Clinical Study Result

There are 83 positive results tested by MAGLUMI 2019-nCoV IgG in 91 clinically confirmed positive samples. While in other 750 clinically
confirmed negative samples, 730 negative results via 2019-nCoV IgG.

Table 1 Clinical sensitivity, specificity and 95% confidence interval of MAGLUMI 2019-nCoV IgG
Study 1 Specimen Category 2019-nCoV IgG(CLIA)

No. Positive %Sensitivity 95% confidence interval

Clinical sensitivity Clinically Confirmed Positive Samples
91 83 91.21% 85.39%~97.03%
No. Negative %Specificity 95% confidence interval
Clinical specificity Negative Specimens
750 730 97.33% 96.18%~98.49%
There are 87 positive results tested by joint detection of MAGLUMI 2019-nCoV IgM and IgG in 91 clinically confirmed positive samples. While in other
750 clinically confirmed negative samples, 720 negative results via joint detection of MAGLUMI 2019-nCoV IgM and IgG.
Table 2 Clinical sensitivity, specificity and 95% confidence interval of joint detection of MAGLUMI 2019-nCoV IgM and IgG
Study 2 Specimen Category 2019-nCoV IgM (CLIA)+2019-nCoV IgG (CLIA)

No. Positive %Sensitivity 95% confidence interval

Clinical sensitivity Clinically Confirmed Positive Samples
91 87 95.6% 91.39%~99.82%
No. Negative %Specificity 95% confidence interval
Clinical specificity Negative Specimens
750 720 96.0% 94.60%~97.40%

Conclusion and Discussion

The clinical study showed that clinical sensitivity and specificity of MAGLUMI 2019-nCoV IgG is 91.21% and 97.33%. After joint detection of
MAGLUMI 2019-nCoV IgM and 2019-nCoV IgG, the clinical sensitivity and specificity of COVID-19 will improve to 95.60% and 96.00%. The
detection results indicate that MAGLUMI 2019-nCoV IgM and 2019-nCoV IgG have a good clinical value on assisting the diagnosis of COVID-19.
Thus, it is recommended to joint detect MAGLUMI 2019-nCoV IgM and 2019-nCoV IgG to improve the clinical detection rate of COVID-19.
The positive rate of IgG and IgM antibodies may be affected by the infection period of the test subject (when blood sampling) in different studies.

Reference
[1] Roujian Lu, Xiang Zhao, Juan Li, et al, Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. The Lancet. Volume
395, Issue 10224, 22–28 February 2020, Pages 565-574.
[2] Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7). Released by National Health Commission & State Administration of Traditional Chinese Medicine
on March 3, 2020