INTRODUCTIONA novel coronavirus infection was identified in December 2019, which confirmed as severe acute respiratory syndrome caused by infection with a new Betacoronavirus. The World Health Organization (WHO) named this new corona-virus as “SARS-CoV-2” and the disease as “COVID-19” that has been causing hundreds of thousands of confirmed human infections worldwide. MDx® COVID-19 Ab Rapid Test is in vitro diagnostic kit to detect IgM and/or IgG against SARS-CoV-2 qualitatively using immuno-chromatographic method. This kit can be applied as a supplemental diagnostic tool to the real time RT-PCR test.

PERFORMANCE DATA

INDEX OF SYMBOLS

1. Clinical sensitivity : 94.3%

2. Clinical specificity : 98.7%

3. Analytical sensitivity Limit of Detection (LoD) : Detectable up to VN(Viral Neutralization) titer 1:8

4. Analytical specificity 1) No cross reactivity against antibodies to 25 different kinds of pathogens as following;

2) No interference with 14 different immune-response associated materials (IRAM)

In Vitro Diagnostics Consult Instruction Manual

Do Not Reuse Contains Sufficient for <n> Tests

Batch Code (LOT) Manufacturing Date

Expiration Date Temperature Limitation

INTENDED USEMDx® COVID-19 Ab Rapid Test is a chromatographic immunoassay for the qualitative detection of IgM/IgG antibodies to SARS-CoV-2 present in human whole blood, serum and plasma. This test is for in vitro professional diagnostic use and intended as a supplemental method to diagnosis of SARS-CoV-2 infection in convalescent phase of patient with clinical symptoms with COVID-19. It provides only an initial screening test result.

PRINCIPLE OF THE TESTMDx® COVID-19 Ab Rapid Test is based on the principle of immunochromatographic assay for detection of SARS-CoV-2 IgG/IgM antibodies in human whole blood, serum, and plasma. When the specimen is added into the test device, the specimen is absorbed into the sample pad by capillary reaction, binds to the SARS-CoV-2 recombinant antigen-gold particle conjugate and the immune complexes move through the membrane with pre-coated capture antibody lines. When the SARS-CoV-2 antibodies level in the specimen is at or above the cut-off (limit of detection, LoD), the immune complexes (antibodies bound to the antigen-gold conjugate particles) are captured by anti-human IgG (T2) and/or anti-human IgM (T1) immobilized as the test lines in the device, visualizing a colored test band that indicates a positive result. When the SARS-CoV-2 antibody level in the specimen is below the cut-off or no antibody, no band is visualized in the Test region (T2 and T1) of the device, indicating a negative test result. If the test performed properly, a colored line should always appear at the Control line (C).

SPECIMEN AND SAMPLE PREPARATION1. For whole blood 1) Finger stick blood a. Clean and disinfect the area to be lanced with an 70% alcohol swab. b. Squeeze the end of fingertip and pierce with a sterile lancet. c. Collect the 20 μl of finger stick blood using Capillary Tube. d. The finger stick blood must be tested immediately after collection. 2) Venous whole blood a. Collect the venous whole blood into the blood collection tube containing anticoagulants such as heparin, EDTA, Sodium citrate by venipuncture. b. When the blood in the tube is stored in a refrigerator at 2-8oC/36-46oF, the specimen can be used for testing for 1-2 days after collection. c. Do not use hemolyzed blood specimens.2. For serum 1) Collect whole blood into blood collection tube without anticoagulants by venipuncture and leave it for 30 minutes for coagulation. 2) Centrifuge coagulated blood and quickly collect the serum from the centrifuged tube to avoid hemolysis. 3) If serum in the tube is stored in a refrigerator at 2-8oC/36-46oF, the specimen can be used for testing for 1 week after collection. The specimen needs to be kept at the -20oC/-4oF for longer term storage. 4) The specimen should be warm up at room temperature prior to test.3. For plasma 1) Collect the whole blood into the blood collection tube containing anticoagulants such as heparin, EDTA, Sodium citrate by venipuncture and centrifuge the whole blood to collect plasma. 2) If plasma in the tube is stored in a refrigerator at 2-8oC/36-46oF, the specimen can be used for testing for 1 week after collection. The specimen needs to be kept at the -20oC/-4oF for longer term storage. 3) The specimen should be warm up at room temperature prior to test.

PRECAUTION1. This kit is for in vitro diagnostic use only.2. All specimens should be treated as potentially infectious materials. Use appropriate precautions in collection, handling, storage, and disposal of samples and used kit components according to biosafety level 2 or higher guidelines.3. Wear appropriate personal protective equipment (eg, gown, gloves, mask, eye protection etc.) when handling and testing the specimens. 4. Follow the direction of the instruction manual strictly for an accurate result.5. After tearing the foil pouch, use the device as soon as possible (<10 minutes). Moisture can negatively affect on the performance of the device. 6. Discard the device and Capillary Tube after use. These components cannot be used more than once. 7. When Capillary Tube is used for blood collection, the small hole at the end of the Capillary Tube should not be blocked for efficient capillary reaction.8. Do not use the kit beyond the expiration date. 9. Testing should be performed by professionally trained staff working in certified laboratories or clinics. 10. Test results should be interpreted by the medical doctor along with clinical findings and other laboratory test results.11. Disposal of the diagnostic device: All specimens and used kit should be treated as bio-hazard wastes. The handling and disposal of all specimens and used kit must follow the all local, state, and national regulations.12. Results from this antibody testing should not be used to inform infection status (early stage of infection or recovery stage etc). 13. This test is only for qualitative assay. Neither the quantitative value nor the concentration of anti-SARS- CoV-2 antibody can be determined by this kit.

COMPOSITION OF KIT

MDx® COVID-19 Ab Rapid TestCat No. MDX-CVD-21 MFDS License No. 20-580

MDx® COVID-19 Ab Rapid TestInstruction Manual_Rev. 2020-04E

No.1234

No.123456789

10111213141516171819202122232425

1

2

3

4

5

6

7

Bilirubin

Hemoglobin

Mouse IgG

EDTA

Heparin

Levofloxacin

Azithromycin

4 mg/dL

17.5 g/dL

1 mg/mL

1.8 mg/mL

18 U/mL

1.25 g/L

2.5 g/L

100%(3/3+)100%(3/3+)100%(3/3+)100%(3/3+)100%(3/3+)100%(3/3+)100%(3/3+)

100%(3/3-)100%(3/3-)100%(3/3-)100%(3/3-)100%(3/3-)100%(3/3-)100%(3/3-)

100%(3/3+)100%(3/3+)100%(3/3+)100%(3/3+)100%(3/3+)100%(3/3+)

100%(3/3+)

100%(3/3-)100%(3/3-)100%(3/3-)100%(3/3-)100%(3/3-)100%(3/3-)

100%(3/3-)

Ceftriaxone

Meropenem

Zanamivir

Oseltamivir

Ribavirin

Ritonavir

Histamine

2.5 g/L

500 mg/L

25 mg/L

187.5 mg/L

375 mg/L

125 mg/L

0.25 mg/L

Name of AntibodyAdenovirus IgM human plasmaChlamydia IgG Antibody Positive human plasmaCytomegalovirus IgG Antibody Positive human plasmaCytomegalovirus IgM Antibody Positive human plasmaEnterovirus IgG human plasmaEnterovirus IgM human plasmaEpstein-Barr Virus VCA IgG human plasmaHBs Antibody Positive human plasma (1000 mIU/ml)HCV Antibody Confirmed Positive human plasmaHIV-1/2 Antibody Positive human plasmaMeasles Virus IgG human plasmaMeasles Virus IgM human plasmaMumps Virus IgG human plasmaMycoplasma IgG Antibody Positive human plasmaMycoplasma IgM Antibody Positive human plasmaSyphilis (T.Pallidum) IgG Antibody Positive human plasmaVaricella Zoster Virus IgG Antibody Positive human plasmaVaricella Zoster Virus IgM Antibody Positive human plasmaBordetella Pertussis IgG Positive plasmaParainfluenza 1/2/3 IgG Positive plasmaInfluenza A Virus IgG Positive plasmaInfluenza A Virus IgM Positive plasmaInfluenza B Virus IgG Positive plasmaRSV IgG Positive plasmaDengue Fever Panel 10ea

CompositionCOVID-19 Ab Test Device (individually in a foil pouch with desiccant)Sample Dilution BufferCapillary Tube (20 μl)Instruction Manual

20 Tests/Kit20 Tests

5 ml/bottle x 1 ea20 ea

1 book

STORAGE AND EXPIRATIONStore the kit at room temperature (2-30oC/36-86oF) avoiding direct sunlight or high humidity. Kit components are stable until the expiration date. Do not freeze the kit.

Manufacturer : MEDIAN Diagnostics Inc. 878, Sunhwan-daero, Dongnae-myeon, Chuncheon-si, Gangwon-do 24399, Republic of Korea Tel : +82-33-244-0100 Fax : +82-33-244-4634 E-mail : median@mediandx.comWebsite : www.mediandiagnostics.com

LIMITATION OF THE TEST1. This test detects the presence of SARS-CoV-2 IgM/IgG in the specimen such as whole blood, serum and plasma.2. Neither the quantitative value nor the rate of anti-SARS-CoV-2 IgM and IgG concentration can be determined by this qualitative test.3. Failure to follow the test procedure and interpretation of test results may lead to poor test performance and/or invalid results.4. The result of this test should not be used as the sole criteria for the diagnosis of SARS-CoV-2 infection and must be considered with other clinical data available to the physician.5. For more accurate interpretation on immune and infection status, additional follow-up testing using other laboratory methods is recommended.6. When interpreting the positive result, cross reactivity against other related viruses such as SARS and common cold coronavirus is possible. Negative result should be interpreted with the consideration on following factors. 1) Improper collection, delivery or handling of specimens. 2) Lower level of antibody against SARS-CoV-2. 3) Change of antibody recognition motif due to genetic mutation of the virus.

Result of MDx® COVID-19 Ab Rapid Test Positive Negative

Result of MDx® COVID-19 Ab Rapid Test Positive Negative

COVID-19 confirmed bymedical doctor based onclinical signs and real time RT-PCR

Positive (n=35)

Negative (n=0)

Sensitivity 94.3% (95% CI, 80.84% - 99.30%)

33 2

0 0

Positive (n=0)

Negative (n=79)

Specificity 98.7% (95% CI, 93.15% - 99.97%)

0 0

1 78

COVID-19 confirmed bymedical doctor based onclinical signs and real time RT-PCR

No. IRAM Conc.

8

9

10

11

12

13

14

No. IRAM Conc. Agreement of expected result Positive Negative

Agreement of expected result Positive Negative

- 1 -

* Capillary Tube (20 μl) : MFDS License No.14-269, 20 μl capillary tube

INTERPRETATION

KIT COMPONENTS

TEST PROCEDURE

1. IgM Positive : Colored bands at T1 and C

3. IgM & IgG Positive : Colored bands at T1, T2 and C

COVID-19 Ab Test Device(individually in foil pouch with desiccant)

Sample Dilution Buffer (5 ml) Capillary Tube (20 μl) Instruction Manual Box Appearance

5. Invalid : No colored band at C region regardless of T regions’ band

* Note : A colored band should always be visualized at C line regardless of the results at T lines. If C line is not visualized, it is no test. The retest is recommended using new Test Device.

4. Negative : Colored band only at C2. IgG Positive : Colored bands at T2 and C

MDx® COVID-19 Ab Rapid TestCat No. MDX-CVD-21 MFDS License No. 20-580

MDx® COVID-19 Ab Rapid TestInstruction Manual_Rev. 2020-04E

Sensitivity 94.3% (95% CI, 80.84% - 99.30%)

Specificity 98.7% (95% CI, 93.15% - 99.97%)

1. For whole blood (Finger stick blood) 1) Remove a test device from the foil pouch by tearing at the notch and place it on a flat and level surface. 2) Using a Capillary Tube, collect the 20 μl of finger stick blood to the black line of the Capillary Tube. 3) Using a Capillary Tube, add the collected 20 μl of finger stick blood into the sample hole (S). 4) Add 3 drops (100 μl) of Sample Dilution Buffer. 5) Wait for 10-15 minutes and read the result. Do not wait for longer than 15 minutes before reading the result.

2. For serum, plasma, whole blood (Venous whole blood) 1) Remove a test device from the foil pouch by tearing at the notch and place it on a flat and level surface. 2) Collect the 10 μl of serum or plasma or 20 μl of whole blood with micropipette. 3) Transfer 10 μl of serum or plasma or 20 μl of whole blood to the sample hole with micropipette. 4) Add 3 drops (100 μl) of Sample Dilution Buffer. 5) Wait for 10-15 minutes and read the result. Do not wait for longer than 15 minutes before reading the result.

3 drops (~100 μl)

1. Device Preparation 2. Collect the specimen

3. Add the specimen

5. Read the result (in 10-15 minutes)

4. Add Sample Dilution Buffer

10-15 mins

3 drops (~100 μl)

4. Add Sample Dilution Buffer Finger stick blood : 20 μl

Serum, Plasma : 10 μlVenous whole blood : 20 μl

Serum, Plasma : 10 μlVenous whole blood : 20 μl

5. Read the result (in 10-15 minutes)

10-15 mins

1. Device Preparation 2. Collect the specimen

3. Add the specimen

- 2 -

SampleDilutionBuffer

MDx® COVID-19 Ab Rapid Test

Cat No. MDX-CVD-21

20 Tests/Kit

20 μl

20 μl

SampleDilutionBuffer

SampleDilutionBuffer