sars-cov-2 igg/igm rapid test · 23, 2020, there were a total of 77,042 confirmed cases of new...

SARS-CoV-2 IgG/IgM Rapid Test

Validation Report

2020-03-15

Taiyuan Kangwei Pharmacy 80 Yingze Blvd, Shanxi, Taiyuan, People’s Republic of China

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Contents

0. Abstract

1. Test Principle and Characteristics

2. Test Materials

3. Purpose and Evaluation

4. Experimental Design

4.1 The Method

4.2 Specimens Requirements and Storage

4.3 Procedure

4.4 Validation Test

5 Experimental Results and Data Analysis

6 Interference Study

7 Sensitivity Study

8 Specificity Study

9 Repeatability Study

10 Reproducibility Study

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Abstract:

The SARS-CoV-2 IgG/IgM Rapid Test from Pacific Connect Group is a lateral flow chromatographic immunoassay for the qualitative detection of IgM/IgG anti-Novel coronavirus in human serum, plasma, fingerstick, or whole blood. It is suitable for the auxiliary diagnosis of new coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.

Between the first infection in China on December 2, 2019 and the day of February 23, 2020, there were a total of 77,042 confirmed cases of new coronavirus pneumonia and 2445 deaths reported in China. The cumulative number of confirmed cases in China's Hubei Province and Wuhan City were 64,084, accounting for 83.18% of the total number of cases in China. Meanwhile, by Feb 23, 2020, twenty-seven other countries and regions outside China had reported 1702 confirmed cases and 173 deaths. In view of the current situation of prevention and control, China itself has achieved great results. The number of confirmed and suspected cases continued to decline for more than ten days, and the number of discharged cases continued to rise.

However, what is worrying is the continuing rise and expansion of confirmed cases in regions other than China. Since the outbreak of the epidemic, the Chinese government has forced the introduction of policies, such as city closures and travel restrictions, while sending elite medical teams from all parts of China to the worst-hit areas in Hubei. Up to two months after the outbreak of the epidemic, with the help of a series of policies and the concerted support of the Chinese people, as well as the help of the people of the whole world, China's epidemic has turned its inflection point and achieved remarkable results. Although the new Coronavirus was first seen in China, it has now spread to the world, so epidemic prevention is not just a matter for China, but for the entire planet. We must work together to create a safe living environment for everyone. Since the outbreak of the epidemic, research institutes and institutions throughout China and the world have devoted themselves to the study of the new coronavirus, and while we don’t know everything about it yet, we have learned a lot.

IgM is the primary antibody to appear in the human immune system soon after infected. The detection of SARS-CoV-2 specific IgM during acute infection has the advantages of high sensitivity, early diagnosis, and ability to determine whether the suspected person is

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infected, etc. Therefore, the detection of Coronavirus (SARS-CoV-2) IgM antibody has important clinical significance, which is of great significance to effective control of the large-scale spread of SARS- CoV-2. IgM antibody produces after several days of virus infection, and can be detected as early as one week or even 3 days. The time it appears varies from individual to individual. IgG antibody, on the other hand, generally begins to produce 7-14 days after virus infected, maintain time is longer, some cases can maintain throughout the individual’s entire lifetime.

Based on international, domestic and foreign research results of the Novel Coronavirus, we have developed the Covid-19 antigens/antibodies and Covid-19 IgG/IgM Rapid Test. The antigens/antibodies were used in these Covid-19 IgG/IgM antibody test kits. Simultaneously, we have developed the rapid diagnostic kit based on the immune chromatography detection principle. This kit has high sensitivity and high specificity. There is no need to use special instruments or professionally-skilled workers when testing, so it is very simple and timely. With people all over the world suffering the epidemic, this kit will be very useful for clinical application, and be of tremendous aid to hospitals and health institutions in diagnosing Covid-19. 1. Test Principle and Characteristics

1.1 Test Principle

The SARS-CoV-2 IgM/IgG Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant antigen conjugated with colloid gold (Covid-19 conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (M and G bands) and a control band (C band). The M band is pre-coated with monoclonal anti-human IgM for the detection of IgM anti- Covid-19, G band is pre-coated with reagents for the detection of IgG anti- Covid-19, and the C band is pre-coated with goat anti rabbit IgG.

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When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. Anti-Covid-19 IgM, if present in the specimen will bind to the Covid-19 conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored M band, indicating a Covid-19 positive test result. Anti-Covid-19 IgG, if present in the specimen will bind to the Covid- 19 conjugates. The immunocomplex is then captured by the pre- coated reagents on the membrane, forming a burgundy colored G band, indicating a Covid-19 IgG positive test result. Absence of any test bands (M and G) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device. 1.2 Characteristics The Covid-19 IgG/IgM Rapid Test is developed based on the principle of antibody and antigen specific binding. This kit was used to test the IgG and IgM antibodies of Covid-19 from human serum, plasma, fingerstick, or whole blood. Its characteristics as below: Sensitivity: The clinical positive detection rate is 96.2% (50 positive samples) Specificity: The clinical negative coincidence rate is 100% (300 negative samples)

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Convenient: Easy to use, simple , fast, without instrument and getting result into 15 minutes, it is suitable for mass screening, significantly reducing workload and the risk of individual infected in hospitals. Storage and Validity: Store at 2-30°C, room temperature storage for 2 years. Stability: Strict quality control and process optimization, guaranteeing stable and high quality. 2. Test Materials

1) Three lots of SARS-CoV-2 IgG/IgM rapid Test Kits from Pacific Connect Group. Each Lot is 10 kits.

[Batch No:NCP200201, NCP200202, NCP200203]

2) 50 cases of positive samples, including 5 cases of whole blood samples, 30 cases of serum samples and 15 cases of plasma samples. These positive samples were all confirmed diagnosis by PCR and CT.

3) 300 cases of negative samples clinically were confirmed negative for Covid-19 infection patients. Including 5 cases of whole blood and 200 cases of serum and 95 cases of plasma.

3. Purpose and Evaluation

The project is an clinic evaluation, in order to study the clinical positive and negative detection rate of COVID-19 by the SARS-CoV-2 IgG/IgM Rapid Test.

4. Experimental Design

4.1 The Method

4.1.1 Sample source and quantity: Collect serum, plasma and whole blood from our hospital. There are 50 cases of positive samples, including 5 cases of whole blood samples, 30 cases of serum samples and 15 cases of plasma samples. These positive samples all confirmed diagnosis by PCR and CT, and 300 cases of negative samples clinically confirmed negative for Covid-19 infection patients including 5 cases of whole blood and 200 cases of serum and 95 cases of plasma.

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4.1.2 Specimen collection and preparation: follow the rapid test insert strictly.

4.2 Specimen Requirements and Storage

The SARS-CoV-2 IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma/Fingerstick) can be performed using whole blood (from venipuncture or finger stick), serum, or plasma.

To collect Fingers prick Whole Blood specimens:

Wash the patient’s hand, and wait it to be dry. Massage the hand without touching the puncture. Puncture the skin with a sterile lancet. Wipe away the first sign of blood. Gently rub the hand from wrist to palm and to finger to form a rounded drop of blood over the puncture site. Add the Finger stick Whole Blood specimen to the test device by using a capillary tube or hanging drops.

Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.

Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens should be stored at 2-8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2- 8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by finger stick should be tested immediately.

Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.

4.3 Procedure

Operation method: Operate strictly in accordance with the package insert, handle the specimen according to specimen collection and preparation guideline, and read the results according to interpretation of results in the package insert.

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4.4 Validation Test

4.4.1 Positive coincidence rate:

4.4.1.1 IgM positive detection rate of Covid-19 from the positive samples who was infected by novel coronavirus in their serum, plasma or whole blood samples.

4.4.1.2 IgG positive detection rate of Covid-19 from the positive samples who was infected by novel coronavirus in their serum, plasma or whole blood samples.

4.4.1.3 Total positive samples are 50 cases who were infected by novel coronavirus .They were confirmed diagnosis by PCR and CT at the same time.

4.4.2 Negative coincidence rate: Negative coincidence rate of patients who were not infected by Novel Coronavirus. Total negative samples is 300 cases who was not infected by novel .They were confirmed diagnosis by PCR and CT at the same time.

4.4.3 The coincidence rate of different lots: The positive coincidence rate and the negative coincidence rate between the three different lots.

5. Experimental Results and Data Analysis

5.1 Statistics of test samples

Total 350 cases samples, including 50 cases positive samples (including 5 cases of whole blood samples, 30 cases of serum samples and 15 cases of plasma samples) and 300 cases negative samples.(Including 5 cases of whole blood and 200 cases of serum and 95 cases of plasma)

5.2 Statistics of positive samples

When the human body attacked by Covid-19, the first responding antibody is IgM. Normally IgM will be produced 3-7 days after infected. IgG will be produced 7-14 days after infected. According to the time of the IgG/IgM antibody produced, we took the specimens from patients on different time. Totally we divided the specimens into 3 groups of positive samples. ( 1-5days, 6-10 days, more than 10days)

Specimen positive IgM IgG Specimen positive

Number positive negative positive negative

1-5 days 15 13 2 5 10

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6-10 days 25 25 0 15 10 More than 10 days

10 7 3 10 0

5.3 Results of the positive samples

We use the three lots of the SARS-CoV-2 IgG/IgM rapid test kits from Pacific Connect Group . The dates are as table.

Specimen positive

NCP200201 NCP200202 NCP200203

IgM( +)

IgM (-)

IgG( +)

IgG (-)

IgM( +)

IgM (-)

IgG( +)

IgG (-)

IgM( +)

IgM (-)

IgG( +)

IgG (-)

1-5 days 13 2 5 10 13 2 5 10 13 2 5 10

6-10 days

24 1 14 11 24 1 14 11 24 1 14 11

More than 10 days

6 4 10 0 6 4 10 0 6 4 10 0

Coincide nce rate

95.6% 96.7% 95.6% 96.7% 95.6% 96.7%

5.4 Results of the Negative samples

We use the three lots of the SARS-CoV-2 IgG/IgM rapid test kits to test 300 cases of negative samples. The date are as table.

Specimen positive

NCP200201 NCP200202 NCP200203

IgM( +)

IgM (-)

IgG( +)

IgG (-)

IgM( +)

IgM (-)

IgG( +)

IgG (-)

IgM( +)

IgM (-)

IgG( +)

IgG (-)

300 0 300 0 300 0 300 0 300 0 300 0 300

Coincide nce rate

100% 100% 100% 100% 100% 100%

5.5 In Conclusion

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1,The total of 15 specimens were test from 1-5 days, the coincidence rate of IgM is 100%, the coincidence rate of IgG is 100%;

2,The total of 25 specimens were test from 6-10days, the coincidence rate of IgM is 96%, the coincidence rate of IgG is 93.3%;

3,The total of 10 specimens were test from more than 10 days, the coincidence rate of IgM is 90%, the coincidence rate of IgG is 100%;

4,Total of 50 specimens were test, the coincidence rate of IgM is 95.6%, the coincidence rate of IgG is 96.7%;

5,Total of 300 specimens were test, the coincidence rate of IgM is 100%.

6, There is no significant differences in three lots of this kit.

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7 Interference Study Some potentially interfering substances were added to either COVID-

19 IgG/IgM negative serum specimens or positive serum specimens, none of the

substances at the certain concentration tested interfered in the assay.

Purpose The following study was done to confirm that the substances do not interfere with the

performance of the SARS-CoV-2 IgG/IgM Rapid Test in certain concentration. Reference

The study was conducted according to Technical Specification of

SARS-CoV-2 IgG/IgM Rapid Test.

Materials Three sequential batches of SARS-CoV-2 IgG/IgM Rapid Test

(Lot#: :NCP200201NCP200202,NCP200203) Method

Effect of other common causative agents of infectious disease

Some positive specimens of other common infectious diseases were spiked into the Novel coronavirus positive and negative specimens and tested separately by each batch of the SARS-CoV-2 IgG/IgM Rapid Test.

Effect of the potentially cross-reactive endogenous substances

Potentially cross-reactive endogenous substances including common serum components, such as lipids, hemoglobin, bilirubin, were spiked at high concentrations

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into the Novel coronavirus positive and negative specimens and tested separately by each batch of the SARS-CoV-2 IgG/IgM Rapid Test.

Effect of some other common biological analytes

Some other common biological analytes, such as acetaminophen, caffeine, ethanol, were spiked into the Novel coronavirus positive and negative specimens and tested separately by each batch of the SARS-CoV-2 IgG/IgM Rapid Test.

Result

Carrying out tests in accordance with standard operating procedures for use of the SARS-CoV-2 IgG/IgM Rapid Test Cassette. The results as follows (*c+'-Positive, Negative):

Effect of other common causative agents of infectious disease

Lot#: NCP200201

Analytes

Specimens

Negative IgG Positive IgM Positive

HIV positive specimen -(10/10) +(10/10) +(10/10)

HAV positive -(10/10) +(10/10) +(10/10)

HBsAg positive -(10/10) +(10/10) +(10/10)

HCV positive -(10/10) +(10/10) +(10/10)

TP positive specimen -(10/10) +(10/10) +(10/10)

HTLV positive -(10/10) +(10/10) +(10/10)

CMV positive -(10/10) +(10/10) +(10/10)

FLU A positive -(10/10) +(10/10) +(10/10)

FLUB positive -(10/10) +(10/10) +(10/10)

RSV positive specimen -(10/10) +(10/10) -(10/10)

MP positive specimen -(10/10) +(10/10) +(10/10)

CP positive specimen -(10/10) +(10/10) +(10/10)

HPIVs positive -(10/10) +(10/10) +(10/10)

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Lot#:NCP200202

Analytes

Specimens



HAV positive -(10/10) +(10/10) +(10/10)

HBsAg positive -(10/10) +(10/10) +(10/10)

HCV positive -(10/10) +(10/10) +(10/10)


HTLV positive -(10/10) +(10/10) +(10/10)

CMV positive -(10/10) +(10/10) +(10/10)

FLU A positive -(10/10) +(10/10) +(10/10)

FLU B positive -(10/10) +(10/10) +(10/10)

RSV positive specimen -(10/10) +(10/10) -(10/10)



HPIVs positive -(10/10) +(10/10) +(10/10)

Lot#: NCP200203

Analytes

Specimens



HAV positive -(10/10) +(10/10) +(10/10)

HBsAg positive -(10/10) +(10/10) +(10/10)

HCV positive -(10/10) +(10/10) +(10/10)


HTLV positive -(10/10) +(10/10) +(10/10)

CMV positive -(10/10) +(10/10) +(10/10)

FLUA positive -(10/10) +(10/10) +(10/10)

FLUB positive -(10/10) +(10/10) +(10/10)

RSV positive specimen -(10/10) +(10/10) +(10/10)


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HPIVs positive -(10/10) +(10/10) +(10/10) Effect of the potentially cross-reactive endogenous substances

Lot#: NCP202001

Analytes

Cone.

Specimens


Albumin 20mg/ml -(10/10) +(10/10) +(10/10)

Bilirubin 20ug/ml -(10/10) +(10/10) +(10/10)

Hemoglobin 15mg/ml -(10/10) +(10/10) +(10/10)

Glucose 20mg/ml -(10/10) +(10/10) +(10/10) Uric Acid 200ug/ml -(10/10) +(10/10) +(10/10)

Lipids 20mg/ml -(10/10) +(10/10) +(10/10)

Lot#: NCP202002

Albumin 20mg/ml -(10/10) +(10/10) +(10/10)

Bilirubin 20 ug/ml -(10/10) +(10/10) +(10/10)

Hemoglobin 15mg/ml -(10/10) +(10/10) +(10/10)

Glucose 20mg/ml -(10/10) +(10/10) +(10/10)

Uric Acid 200ug/ml -(10/10) +(10/10) +(10/10)

Lipids 20mg/ml -(10/10) +(10/10) +(10/10)

Lot#: NCP202003

Analytes

Cone.

Specimens


Albumin 20mg/ml -(10/10) +(10/10) +(10/10)

Bilirubin 20ug/ml -(10/10) +(10/10) +(10/10)

Hemoglobin 15mg/ml -(10/10) +(10/10) +(10/10)

Glucose 20mg/ml -(10/10) +(10/10) +(10/10)

Uric Acid 200ug/ml -(10/10) +(10/10) +(10/10)

Lipids 20mg/ml -(10/10) +(10/10) +(10/10)

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Effect of some other common biological analytes Lot#: NCP202001

Analytes

Cone.

(ug/ml)

Specimens

Negative

IgG Positive

IgM Positive

Acetaminophen

200

-(10/10)

+(10/10)

+(10/10)

Acetoacetic Acid

200

-(10/10)

+(10/10)

+(10/10)

Acetylsalicylic Acid

200

-(10/10)

+(10/10)

+(10/10)

Benzoylecgonin e

100

-(10/10)

+(10/10)

+(10/10) Caffeine

200

-(10/10)

+(10/10)

+(10/10)

EDTA.

800

-(10/10)

+(10/10)

+(10/10)

Ethanol

1.0%

-(10/10)

+(10/10)

+(10/10)

Gentisic Acid

200

-(10/10)

+(10/10)

+(10/10)

P - Hydroxybutyra te

20,000

-(10/10)

+(10/10)

+(10/10) Methanol

10.0%

-(10/10)

+(10/10)

+(10/10)

Phenothiazine

200

-(10/10)

+(10/10)

+(10/10)

Phenylpropano lamine

200

-(10/10)

+(10/10)

+(10/10) Salicylic Acid

200

-(10/10)

+(10/10)

+(10/10)

Lot#: NCP200202

Analytes

Cone.

(ug/ml)

Specimens

Negative

IgG Positive

IgM Positive

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Acetaminophen

200

-(10/10)

+(10/10)

+(10/10)

Acetoacetic Acid

200

-(10/10)

+(10/10)

+(10/10)


200

-(10/10)

+(10/10)

+(10/10)

Benzoylecgonin e

100

-(10/10)

+(10/10)

+(10/10) Caffeine

200

-(10/10)

+(10/10)

+(10/10)

EDTA.

800

-(10/10)

+(10/10)

+(10/10)

Ethanol

1.0%

-(10/10)

+(10/10)

+(10/10)

Gentisic Acid

200

-(10/10)

+(10/10)

+(10/10)


20,000

-(10/10)

+(10/10)

+(10/10) Methanol

10.0%

-(10/10)

+(10/10)

+(10/10)

Phenothiazine

200

-(10/10)

+(10/10)

+(10/10)


200

-(10/10)

+(10/10)


200

-(10/10)

+(10/10)

+(10/10)

Lot#: NCP200203

Analytes

Cone.

(ug/ml)

Specimens

Negative

IgG Positive

IgM Positive

Acetaminophen

200

-(10/10)

+(10/10)

+(10/10)

Acetoacetic Acid

200

-(10/10)

+(10/10)

+(10/10)


200

-(10/10)

+(10/10)

+(10/10)

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Benzoylecgonin e

100

-(10/10)

+(10/10)

+(10/10) Caffeine

200

-(10/10)

+(10/10)

+(10/10)

EDTA.

800

-(10/10)

+(10/10)

+(10/10)

Ethanol

1.0%

-(10/10)

+(10/10)

+(10/10)

Gentisic Acid

200

-(10/10)

+(10/10)

+(10/10)


20,000

-(10/10)

+(10/10)

+(10/10) Methanol

10.0%

-(10/10)

+(10/10)

+(10/10)

Phenothiazine

200

-(10/10)

+(10/10)

+(10/10)


200

-(10/10)

+(10/10)


200

-(10/10)

+(10/10)

+(10/10)

Conclusion Interferences of common exogenous and endogenous potential interfering

substances and cross-reactivity of some kinds of positive samples were tested. It

showed that no interference was found in these tests

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7 Sensitivity Study

Purpose

This test was to validate that the sensitivity of the SARS-CoV-2 IgG/IgM Rapid

Test.

Reference



Materials

Three sequential batches of the SARS-CoV-2 IgG/IgM Rapid Test (Lot#:

NCP200201, NCP200202, NCP200203).

Test samples: 5 borderline COVID-19 IgG positive serum control and

5 borderline COVID-19 IgM positive serum control.

Method

Each batch of the SARS-CoV-2 IgG/IgM Rapid Test should be tested by each test

sample above for five times for each sample.

Evaluation Criteria

All the samples shall yield positive results.

Result

Carrying out tests in accordance with standard operating procedures for use of the

SARS-CoV-2 IgG/IgM Rapid Test Cassette. The results as follows ("+"=Positive, "-

"=Negative): Lot#: NCP200201

Specimens

n Visual Result

IgM (+/+) IgG (+/+)

L 1 (borderline COVID-19 IgG positive) 5 0/5 5/5

L 2(borderline COVID-19 IgG positive) 5 0/5 5/5


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L 6(borderline COVID-19 IgM positive) 5 5/5 0/5 L 7(borderline COVID-19 IgM positive) 5 5/5 0/5 L 8(borderline COVID-19 IgM positive) 5 5/5 0/5

L 9(borderline COVID-19 IgM positive) 5 5/5 0/5

L10(borderline COVID-19 IgM positive) 5 5/5 0/5

Lot#: NCP200202

Specimens

n Visual Result

IgM (+/+) IgG (+/+)







L 7(borderline COVID-19 IgM positive) 5 5/5 0/5 L 8(borderline COVID-19 IgM positive) 5 5/5 0/5



Lot#: NCP200203

Specimens

n Visual Result

IgM (+/+) IgG (+/+)






L 6(borderline COVID-19 IgM positive) 5 5/5 0/5 L 7(borderline COVID-19 IgM positive) 5 5/5 0/5 L 8(borderline COVID-19 IgM positive) 5 5/5 0/5



Conclusion

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All borderline COVID-19 IgG positive serum specimens IgG test region had positive

results while IgM test region had negative result, All borderline COVID-19 IgM

positive serum specimens IgM test region had positive results while IgG test region

had negative result It indicates that the sensitivity of the SARS-CoV-2 IgG/IgM

Rapid Test is consistent with the standards

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8 Specificity Study

Purpose

The following study was done to validate that the analytical specificity of the SARS-CoV-2 IgG/IgM Rapid Test.

Reference



Materials


NCP200201, NCP200202, NCP200203).

Test samples: 20 COVID-19 IgG/IgM negative controls.

Method

Each batch of the SARS-CoV-2 IgG/IgM Rapid Test should be tested by each test

sample above for once for each sample.

Evaluation Criteria

All of the 20 COVID-19 IgG/IgM negative controls should be tested negative.

Result



The results as follows (“+”=Positive ,“-”= Negative):

Lot No. Test Result (-/-)

NCP202001 20/20 NCP200202 20/20

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NCP200203 20/20

Conclusion

All of the 20 negative controls were tested negative. It indicates that the analytical

specificity of the SARS-CoV-2 IgG/IgM Rapid Test is good.

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9. Repeatability Study

1. Purpose

This test was to validate that the repeatability of SARS-CoV-2 IgG/IgM Rapid Test is

good.

2. Reference

The study was conducted according to Technical Specification of CO VID-19

IgG/IgM Rapid Test.

3. Materials

Reagents: three sequential batches of the SARS-CoV-2 IgG/IgM Rapid

Test (Lot#: NCP200201, NCP200202, NCP200203).

Test Samples: 1 borderline COV1D-I9 IgG positive serum control and

1 borderline COVID-19 IgG positive serum control.

4. Method

Each batch of the SARS-CoV-2 IgG/IgM Rapid Test should be tested by above test

samples for 10 times.

4.1 Evaluation Criteria

If the test results of reagents from the same batch are positive, and the color degree

of the test results is uniform, it indicates that the with in-batch repeatability is good.

If the test results of reagents from the different batches are positive, and the color degree

of the test results is uniform, it indicates that the between-run repeatability is good.

5. Result


SARS-CoV-2 IgG/IgM Rapid Test. The results as follows (''+"=Positive, Negative):

Sample No.

Borderline COVID-19 IgG positive Lot#: NCP200201 Lot#: NCP200202 Lot#: NCP200203

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1 + + + 2 + + + 3 + + + 4 + + + 5 + + + 6 + + + 7 + + + 8 + + + 9 + + + 10 + + +

Sample No,

Borderline COVID-19 IgM positive Lot#: NCP200201 Lot#: NCP200202 Lot#: NCP200203

1 + + + 2 + + + 3 + + + 4 + + + 5 + + + 6 + + + 7 + + + 8 + + + 9 + + + 10 + + +

Conclusion

All of the test results were positive, and the color degree of the test results was uniform.

It indicates that the within-batch repeatability and between-run repeatability of the

SARS-CoV-2 IgG/IgM Rapid Test are both good.

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10.Reproducibility Study

Purpose

This test was to validate that the reproducibility of the SARS-CoV-2

IgG/IgM Rapid Test is good.

Reference

The study was conducted according to Technical Specification of CO VID-19

IgG/IgM Rapid Test.

Materials


NCP200201, NCP200202, NCP200203).

Methodology

Reproducibility studies were performed for SARS-CoV-2 IgG/IgM Rapid Test at three

physician office laboratories (POL). Sixty (60) clinical serum specimens, 20 negative,

20 borderline positive and 20 positive, were used in this study. Each specimen was run

in triplicate for three days at each POL.

Evaluation Criteria

The intra-assay agreement should not be less than 99% at each site, and the inter-site

agreement should not be less than 99% as well. Result

Carrying out tests in accordance with standard operating procedures

fbr use of the SARS-CoV-2 IgG/IgM Rapid Test. The results as follows

("+''=Positive, Negative): Lot#:NCP200201

Date

Specimen Test Result

Site A SiteB SiteC Negative -(20/20) -(20/20) -(20/20)

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1sl day

Borderline IgG positive +(10/10) +(10/10) +(10/10) Borderline IgM positive +(10/10) +(10/10) +(10/10) IgG Positive +(10/10) +(10/10) +(10/10) IgM Positive +(10/10) +(10/10) +(10/10)

2nd day

Negative -(20/20) -(20/20) -(20/20) Borderline IgG positive +(10/10) +(10/10) +(10/10) Borderline IgM positive +(10/10) +(10/10) +(10/10) IgG Positive +(10/10) +(10/10) +(10/10) IgM Positive +(10/10) +(10/10) +(10/10)

3rd day


Intra-assay agreement 100% 100% 100% Inter-site agreement 100%

Lot#:NCP200202

Date

Specimen Test Result Site A SiteB SiteC

1sl day


2nd day


3rd day


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Lot#:NCP200203

Date

Specimen Test Result

Site A SiteB SiteC

1sl day


2nd day


3rd day



Conclusion

Each specimen was run in triplicate for three days at each POL. The intra-assay agreements were 100%. The inter-site agreement was

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100 %. All test results of the three sequential batches products were consistent, and met the test criterion. It indicates that the reproducibility of SARS-CoV-2 IgG/IgM Rapid Test is good.

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End of Document

sars-cov-2 igg/igm rapid test · 23, 2020, there were a total of 77,042 confirmed cases of new...

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