EUA 201421

Clinical Sensitivity and Specificity Report of

One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG
antibody (Colloidal Gold)
1. Summary

One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody (Colloidal Gold) is intended for the qualitative

detection of 2019-Novel Coronavirus IgM and IgG antibody in serum, plasma of pneumonitis patients or suspected

cases.

2．Research method

2.1 Trial reagent

Name: One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)
Manufacturer: Getein Biotech, Inc.
Lot no.: GGM20015w
Lot no.: GGM20124w
2.2 Data processing methods

Table 1 The test results of trial reagent and comparator reagent

comparator reagent
Experiment
positive negative

positive a b

trial reagent negative c d

Calculation with the following formula:

Positive percent agreement = a / (a+c) ×100%

Negative percent agreement = d / ( b+d)×100%

2. Calculation method of 95% confidence interval

(1) The formula for calculating 95% confidence interval of total coincidence rate

[ 100% (Q1－Q2) /Q3，100% (Q1＋Q2) / Q3 ]

Q1=2 (a+d) +1.962

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 EUA 201421

Q2=1.96√1.962 + 4（a + d）(b + c)/n

Q3=2（n+1.962）

(2) The formula for calculating 95% confidence interval of PPA

[ 100% (Q1, ppa－Q2, ppa) / Q3, 100% (Q1, ppa＋Q2, ppa) / Q3, ppa ]

Q1, ppa =2a+1.962

Q2,ppa =1.96√1.962 + 4ac/(a + c)

Q3, ppa =2（a+c+1.962）

(3) The formula for calculating 95% confidence interval of NPA

［100%*(Q1, npa－Q2, npa)／Q3, npa, 100%*(Q1, npa＋Q2, npa)／Q3, npa］

Q1, npa =2d+1.962

Q2, npa =1.96√1.962 + 4bd/(b + d)

Q3, npa =2（b+d+1.962）

3.Data analysis

110 serum and plasma samples( 80 negative and 30 positive samples) were selected from the Fifth People's Hospital

of Wuxi、the Second Hospital of Huangshi and the Second Hospital of Nanjing, These samples were tested with

PGM20015W (original) and PGM20124W (improved) respectively. The test results of were summarized as follows:

Table2: The test results of the negative samples

Days of Days PGM20124W PGM20015W

Patient Date of initial from PCR (improved) (original)
Sex
ID Birth PCR symptom result Total Total
IgM IgG IgM IgG
detection onset result result
19007642 male 1981.6.28 3 17 - + - - - - -
19061174 male 1999.9.3 4 18 - - - - - - -
19066393 male 1978.6.29 6 20 - - - - - - -
19092556 female 2006.3.2 5 19 - - - - - - -
19109231 female 1987.2.21 5 19 - - - - - - -
19112206 male 1967.11.14 7 21 - - - - - - -
19112750 female 1978.2.21 5 19 - - - - - - -
19113786 female 1972.4.20 4 18 - - - - - - -
19126113 male 2008.6.3 5 19 - - - - - - -
19138504 female 2006.9.12 4 18 - - - - - - -

Add: No.9 Bofu Road, Luhe District, Nanjing (211505) China. Web: www.bio-gp.com.cn
Tel: 86-25-68568508 Fax: 86-25-68568500 Email: tech@getein.com.cn
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 EUA 201421
19165259 female 1979.11.26 5 19 - - - - - - -
19167312 male 1973.12.2 6 20 - - - - - - -
19174044 male 2007.7.23 5 19 - - - - - - -
19196033 female 1969.7.19 5 19 - - - - - - -
19218350 male 1988.10.15 5 19 - - - - - - -
19255380 male 1983.2.15 5 19 - - - - - - -
19278649 male 1970.7.16 4 18 - - - - - - -
19281745 male 1969.9.20 3 17 - - - - - - -
19334544 male 1988.11.22 7 21 - - - - - - -
19334954 female 1966.7.22 5 19 - - - - - - -
19363249 male 1992.11.19 3 17 - - - - - - -
19379297 male 2000.5.14 6 20 - - - - - - -
19451240 male 1979.1.8 6 20 - - - - - - -
19462005 female 1974.10.14 5 19 - - - - - - -
19473083 male 1983.7.19 5 19 - - - - - - -
19476341 male 1997.2.8 6 20 - - - - - - -
19499702 male 1978.12.10 5 19 - - - - - - -
19525275 male 1974.12.21 6 20 - - - - - - -
19543869 male 2007.10.24 3 17 - - - - - - -
19565232 female 1995.11.23 2 16 - - - - - - -
19664888 male 1986.12.29 6 20 - - - - - - -
19703458 male 1970.4.14 4 18 - - - - - - -
19704170 female 1986.8.2 6 20 - - - - - - -
19712217 female 1983.2.27 7 21 - - - - - - -
19730677 female 1983.7.1 2 16 - - - - - - -
19736205 male 1986.11.12 6 20 - - - - - - -
19741190 female 1968.12.18 2 16 - - - - - - -
19756769 male 1977.7.1 4 18 - - - - - - -
19774632 male 1974.7.1 3 17 - - - - - - -
19793904 male 1997.10.19 5 19 - - - - - - -
19855241 male 1984.4.12 5 19 - - - - - - -
19873793 male 1965.7.11 4 18 - - - - - - -
19895659 male 1976.8.15 5 19 - - - - - - -
19913040 male 2006.6.13 4 18 - - - - - - -
19936964 male 1966.9.7 5 19 - - - - - - -
19967749 male 1986.6.15 6 20 - - - - - - -
19969985 male 1992.3.16 2 16 - - - - - - -
19976268 female 2006.7.20 3 17 - - - - - - -
19997281 male 2001.8.24 6 20 - - - - - - -
20000438 male 1971.12.2 3 17 - - - - - - -
20011370 male 1996.4.18 6 20 - - - - - - -

Add: No.9 Bofu Road, Luhe District, Nanjing (211505) China. Web: www.bio-gp.com.cn
Tel: 86-25-68568508 Fax: 86-25-68568500 Email: tech@getein.com.cn
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 EUA 201421
20012106 female 1943.9 6 20 - - - - - - -
20016080 male 1982.3.22 3 17 - - - - - - -
20017211 male 1970.9.29 3 17 - - - - - - -
20020014 male 2013.10.1 5 19 - - - - - - -
20020031 female 1990.2 3 17 - - - - - - -
20020033 female 1974.6.22 5 19 - - - - - - -
20020054 male 1979.12.7 4 18 - - - - - - -
20020065 male 1958.6.8 7 21 - - - - - - -
20020068 male 1947.4.11 5 19 - - - - - - -
20020102 male 1961.06 4 18 - - - - - - -
20020111 female 1986.9.6 7 21 - - - - - - -
20020115 male 2008.06 6 20 - - - - - - -
20020120 male 1998.06 3 17 - - - - - - -
20020124 female 1971.05 2 16 - - - - - - -
20020126 female 1959.09 2 16 - - - - - - -
20020128 male 2004.05 5 19 - - - - - - -
20020138 male 1962.3.20 4 18 - - - - - - -
20020148 male 1995.01 4 18 - - - - - - -
20020151 male 1955.02 7 21 - - - - - - -
20020167 male 1937.08 5 19 - - - - - - -
20020169 female 1981.01 5 19 - - - - - - -
20020175 male 1954.03 6 20 - - - - - - -
20020178 female 1984.08 5 19 - - - - - - -
20020181 female 1992.5.12 4 18 - - - - - - -
20020196 male 1951.02 6 20 - - - - - - -
20020227 female 1990.4.4 5 19 - - - - - - -
20020633 male 1969.7.28 5 19 - - - - - - -
20021121 male 1973.1 4 18 - - - - - - -
20021142 male 1966.10.11 6 20 - - - - - - -

Table3：The test results of the positive samples with ≤6 days from symptom onset

Days of Days PGM20124W PGM20015W

Patient Date of initial from PCR
Sex Total Total
ID Birth/Age PCR symptom result IgM IgG IgM IgG
detection onset result result
2001323 female 1991.3.15 2 4 + ± + + ± + +
2000275 female 1977.4.13 3 5 + + + + + + +
20012011 male 1998.9.6 3 5 + ± - + ± - +
2000182 female 1988.7.19 2 6 + - - - - - -
19551907 male 1995.8.26 4 6 + + + + - - -

Add: No.9 Bofu Road, Luhe District, Nanjing (211505) China. Web: www.bio-gp.com.cn
Tel: 86-25-68568508 Fax: 86-25-68568500 Email: tech@getein.com.cn
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 EUA 201421
20009574 male 1996.4.23 4 6 + + + + - - -
19863405 male 1989.12.9 2 6 + ± ± + - - -

Table4：The test results of the positive samples with 7-10 days from symptom onset

Days of Days PGM20124W PGM20015W

Patient Date of initial from PCR
Sex Total Total
ID Birth/Age PCR symptom result IgM IgG IgM IgG
result result
detection onset
2000480 female 1969.9.28 4 7 + + + + + + +
2001135 male 1974.7.20 3 7 + + + + + + +
19550895 female 1992.7.27 3 9 + + + + - - -
20006781 female 1956.10.14 7 9 + ± + + - - -
20011017 male 1987.1.30 3 9 + - - - - - -

Table5：The test results of the positive samples with 11-14 days from symptom onset

Days of Days PGM20124W PGM20015W

Date of initial from PCR
Patient ID Sex Total Total
Birth/Age PCR symptom result IgM IgG IgM IgG
result result
detection onset

2000692 female 1966.1.2 4 11 + + + + + + +

2001166 female 1950.2.1 3 11 + + + + + + +

20014797 female 2002.4.5 5 11 + + + + + + +
19872970 male 1982.10.28 4 12 + + + + + + +
2001140 female 1971.12.11 3 14 + ± + + ± + +

Table6：The test results of the positive samples with ≥14 days from symptom onset

Days of Days
PGM20124W PGM20015W
Date of initial from PCR
Patient ID Sex
Birth/Age PCR symptom result
Total Total
detection onset IgM IgG IgM IgG
result result
20011010 male 1966.5.4 3 16 + + + + + + +
20061174 female 1959.6.1 6 16 + + + + + + +
2000856 male 2008.06.01 3 17 + + + + + + +
2001341 female 1994.2.26 3 17 + ± + + ± + +
19670055 male 1998.10.28 5 17 + + + + + + +
19719413 male 1975.12.28 5 17 + + + + + + +
2001190 female 1977.5.27 3 18 + + + + + + +
19454957 male 1986.12.30 5 18 + + + + + + +

Add: No.9 Bofu Road, Luhe District, Nanjing (211505) China. Web: www.bio-gp.com.cn
Tel: 86-25-68568508 Fax: 86-25-68568500 Email: tech@getein.com.cn
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 EUA 201421
20010078 male 1976.11.7 4 19 + + + + + + +
20012695 male 2002.3.27 4 21 + + + + + + +
20018792 female 1983.4.20 7 21 + + + + + + +
20017390 female 1987.12.9 5 36 + - + + - + +
19695263 male 2009.9.30 7 37 + - + + - + +
According to the test data, the test results were summarized as follows:

Table 7: Overall clinical study results for all time periods from symptom onset
PGM20124W PGM20015W
S/P
positive negative Total positive negative Total

IgG+/IgM+ 25 0 25 20 0 20
Trail positive
IgG-/IgM+ 1 1 2 1 0 1
reagent
IgG+/IgM- 2 0 2 2 0 2
negative IgG-/IgM- 2 79 81 7 80 87

Total 30 80 110 30 80 110

PPA 93.3% 76.7%

NPA 98.7% 100%

IgM sensitivity 86.7% 70.0%

IgM specificity 98.7% 100%

IgG sensitivity 90.0% 76.7%

IgG specificity 100% 100%

According to the test data, positive results by time from symptom onset were summarized as follows:

Table8: SARS-CoV-2 IgG/IgM results analysis by time from symptom onset

Infectious PCR PGM20124W PGM20015W

period IgM IgG IgG IgM IgM IgG IgG

positive positive PPA IgM PPA positive PPA
(days) positive positive PPA positive PPA positive PPA

≤6 days 7 6 85.7% 6 85.7% 5 71.4% 3 42.9% 3 42.9% 2 28.6%

7-10 days 5 4 80.0% 4 80.0% 4 80.0% 2 40.0% 2 40.0% 2 40.0%

11-14 days 5 5 100.0% 5 100.0% 5 100.0% 5 100.0% 5 100.0% 5 100.0%

≥14days 13 13 100.0% 11 84.6% 13 100.0% 13 100.0% 11 84.6% 13 100.0%

Total

consistent 30 28 93.3% 26 86.7% 27 90.0% 23 76.7% 21 70.0% 22 73.3%

rate

Add: No.9 Bofu Road, Luhe District, Nanjing (211505) China. Web: www.bio-gp.com.cn
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 EUA 201421
According to the results of clinical agreement study, 110 clinical patients（80 negative and 30 positive patients）

were tested for SARS-CoV-2. The positive percent agreement (PPA) of GGM20124W (improved) was93.3%, higher

than 76.7% of PGM20015W(original), the overall negative percent agreement (NPA) of GGM20124W was 98.7%,

lower than 100% of PGM20015W, but, the negative percent agreement (NPA) of 98.7% (GGM20124W) met the

requirements of FDA. Based on specific requirements, GGM20124W PPA (IgM was 86.7% and IgG was 90.0%

respectively) is higher than GGM20015W (IgM was 70.0 % and IgG was 76.7% respectively), GGM20124W

(improved) performance is improved greatly.

Add: No.9 Bofu Road, Luhe District, Nanjing (211505) China. Web: www.bio-gp.com.cn
Tel: 86-25-68568508 Fax: 86-25-68568500 Email: tech@getein.com.cn
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