SD Biosensor Rapid COVID 19 IgM/IgG Test Kit

SD Biosensor Rapid COVID 19 IgM/IgG Test Kit

SD Biosensor Rapid COVID 19 IgM/IgG Test Kit, For Clinical  Box 25 Test

Quality approved by SD BIOSENSOR / For in vitro diagnostics use only KIT CONTENTS
STANDARDTM Q COVID-19 IgM/IgG Duo Test
COVID-19 IgM/IgG Duo
STANDARD Q
PLEASE READ CAREFULLY BEFORE YOU PERFORM THE TEST
Buffer bottle
Test device (individually in a foil pouch with desiccant) Buffer bottle Capillary tube
(10μl) Instructions for use
PREPARATION - Be sure to test both STANDARD Q COVID-19 IgM and IgG simultaneously.
TEST PROCEDURE - Be sure to test both STANDARD Q COVID-19 IgM and IgG simultaneously.
INTERPRETATION OF TEST RESULT
Carefully read instructions for using
STANDARD Q COVID-19 IgM/IgG Duo
Test.
Using serum/plasma/venous whole blood
Using Capillary whole blood
Collecting of Specimen
Using a micropipette, collect the 10μl of
serum, plasma or venous whole blood with
micropipette.
10μl
Dropping of buffer
Add 3 drops (90μl) of buffer vertically into the buffer well of the test device.
3 drops
Assay diluent
Adding of Specimen
Add the collected serum, plasma or
venous whole blood to the specimen well
of the test device.
10μl
Reading Time
Read test result at 10~15 minutes.
Read
In 10-15 mins
10 - 15 mins
Do not read
After 15 mins
Reading Time
Read test result at 10~15 minutes.
Read
In 10-15 mins
10 - 15 mins
Do not read
After 15 mins
Open both STANDARD Q COVID-19 IgM and IgG pouches, and check the test devices and
the desiccant in each pouches.

Yellow
Yellow: Valid
Green: Invalid
Green

?
?
?
Result window
Specimen well
Buffer well
TM
STANDARD Q
COVID-19 IgG
2°C
(36°F)
30°C
(86°F)
TM
2°C
(36°F)
30°C
(86°F)
STANDARD Q
COVID-19 IgM
Check the expiry date at the back of the foil
pouch. Do not use the test device, if expiry
date has passed.
/ LOT No.
/ MFG DATE
/ EXP DATE
/ REF No.
/ Item
STANDARD Q COVID-19 IgM/IgG Duo
Q-NCOV-01D
xxxxxxxxxxxx
YYYY.MM.DD.
YYYY.MM.DD.
#Buffer Lot : xxxxxxxxxx
1. A colored band will appear in the top section of the result window to show that the test is working properly. This band is control line (C).
2. A colored band will appear in the lower section of the result window. These bands are test line of IgM/IgG (M, G).
3. Even if the control line is faint, or the test line isn't uniform, the test should be considered to be performed properly and the test result should be interpreted as a positive result.
* STANDARD Q COVID-19 IgM/IgG Duo Test may cross-react with antibody against SARS-CoV-1.
* Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
* Positive results should be considered in conjunction with the clinical history, RT-PCR results and other data available.
Re-test with a new test device.
Positive Negative Invaild
1 2 3 4
4
1 2 3
Q-NCOV-01D
CAUTION
• Do not read test results after
15 minutes. It may give false
results.
CAUTION
• Do not read test results after
15 minutes. It may give false
results.
Collecting of Specimen
Using a capillary tube, collect the 10μl of
capillary whole blood to the black line of the
capillary tube.
10μl
Dropping of buffer
Add 3 drops (90μl) of buffer vertically into
the buffer well of the test device.
3 drops
Assay diluent
Adding of Specimen
Add the collected capillary whole blood to
the specimen well of the test device.
10μl
1 2 3
The test procedures for both COVID-19 IgM and IgG are the same.
EN
STANDARDTM Q COVID-19 IgM/IgG Duo Test
EXPLANATION AND SUMMARY
[Introduction]
Coronavirus is a single-stranded positive-sense RNA virus with an envelope of about 80 to 120 nm in diameter. Its genetic material is the largest of all RNA viruses and is an
important pathogen of many domestic animals, pets, and human diseases. It can cause a variety of acute and chronic diseases. Common signs of a person infected with a
coronavirus include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory
syndrome, kidney failure, and even death. The 2019 new coronavirus, or “COVID-19”, was discovered due to Wuhan Viral Pneumonia cases in 2019 and was named by the World
Health Organization on January 12, 2020. WHO confirmed that COVID-19 can cause colds, the Middle East Respiratory Syndrome (MERS) and more serious diseases such as
severe acute respiratory syndrome (SARS). This kit is helpful for the auxiliary diagnosis of coronavirus infection. The test results are for clinical reference only and cannot be used
as a basis for confirming or excluding cases alone.
[Intended use]
STANDARD Q COVID-19 IgM/IgG Duo Test is a rapid chromatographic immunoassay for the qualitative detection of specific antibodies to SARS-CoV-2 present in human serum,
plasma or whole blood. This test is for in vitro professional diagnostic use and intended as an aid to diagnosis of SARS-CoV-2 infection in convalescent phase of patient with
clinical symptoms with SARS-CoV-2 infection. It provides only an initial screening test result. More specific alternative diagnosis methods should be performed in order to obtain
the confirmation of SARS-CoV-2 infection.
[Test principle]
STANDARD Q COVID-19 IgM/IgG Duo Test has two pre-coated lines, “C” Control line, “G” Test line for the COVID-19 IgG Device and “C” Control line, “M” Test line for the COVID-19
IgM device on the surface of the nitrocellulose membrane. Both the control line and test line in the result window are not visible before applying any specimens. Monoclonal
anti-COVID19 antibody is coated on the control line region and Monoclonal anti-human IgG is coated on the test line region in IgG device and Monoclonal anti-human IgM is
coated on the test line region in IgM device. Recombinant COVID-19 nucleocapsid protein conjugated with colloidal gold particles are used as detectors for COVID-19 IgG Device
and COVID-19 IgM Device. During the test, SARS-CoV-2 antibodies in the Specimen interact with recombinant COVID-19 nucleocapsid protein with colloidal gold particles making
antibody-antigen gold particle complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the Monoclonal anti-human
IgG antibody or Monoclonal anti-human IgM antibody. A violet test line would be visible in the result window if SARS-CoV-2 antibodies are present in the Specimen. The intensity
of violet test line will vary depending upon the amount SARS-CoV-2 antibodies present in the Specimen. If SARS-CoV-2 antibodies are not present in the Specimen, then no color
appears in the test line. The control line is used for procedural control, and should always appear if the test procedure is performed properly and the test reagents of the control
line are working.
[Kit contents]
? Test device (individually in a foil pouch with desiccant) ? Buffer bottle ? Capillary tube (10μl) ? Instructions for use
KIT STORAGE AND STABILITY
Store the kit at room temperature, 2-30°C / 36-86°F, out of direct sunlight. Kit materials are stable until the expiration date printed on the outer box. Do not freeze the kit.
WARNINGS AND PRECAUTIONS
1. Do not re-use the test kit.
2. Do not use the test kit if the pouch is damaged or the seal is broken.
3. Do not use the buffer of another lot.
4. Do not smoke, drink or eat while handling specimen.
5. Wear personal protective equipment, such as gloves and lab coats when handling kit reagents. Wash hands thoroughly after the tests are done.
6. Clean up spills thoroughly using an appropriate disinfectant.
7. Handle all specimens as if they contain infectious agents.
8. Observe established precautions against microbiological hazards throughout testing procedures.
9. Dispose of all specimens and materials used to perform the test as bio-hazard waste. Laboratory chemical and biohazard wastes must be handled and discarded in accordance
with all local, state, and national regulations.
10. Desiccant in foil pouch is to absorb moisture and keep humidity from affecting products. If the moisture indicating desiccant beads change from yellow to green, the test
device in the pouch should be discarded.
11. Good laboratory practice recommends the use of the control materials. Users should follow the appropriate federal state, and local guidelines concerning the frequency of
assaying external quality control materials.
SPECIMEN COLLECTION AND PREPARATION
[Serum]
1. Collect the whole blood into the commercially available plain tube, NOT containing anti-coagulants such as heparin, EDTA, Sodium citrate by venipuncture and leave to settle
for 30 minutes for blood coagulation and then centrifuge blood to get serum specimen of supernatant.
2. If serum in the plain tube is stored in a refrigerator at 2-8°C/36-46°F, the specimen can be used for testing within 1 week after collection. Using the specimen in the long-term
keeping more than 1 week can cause non-specific reaction. For prolonged storage, it should be at below -40°C/-40°F.
3. They should be brought to room temperature prior to use.
[Plasma]
1. Collect the venous blood into the commercially available anti-coagulant tube such as heparin, EDTA, Sodium citrate by venipuncture and centrifuge blood to get plasma
specimen.
2. If plasma in an anti-coagulant tube is stored in a refrigerator at 2-8°C/36-46°F, the specimen can be used for testing within 1 week after collection. Using the specimen in the
long-term keeping more than 1 week can cause non-specific reaction. For prolonged storage, it should be at below -40°C/-40°F.
3. They should be brought to room temperature prior to use.
[Whole blood]
• Capillary whole blood
1. Capillary whole blood should be collected aseptically by fingertip.
2. Clean the area to be lanced with an alcohol swab.
3. Squeeze the end of the fingertip and pierce with a sterile lancet.
4. Using a capillary tube, collect the 10μl of capillary whole blood to the black line of the capillary tube.
5. The capillary whole blood must be tested immediately after collection.
• Venous whole blood
1. Collect the venous whole blood into the commercially available anti-coagulant tube such as heparin, EDTA , Sodium citrate by venipuncture.
2. If venous whole blood in an anti-coagulant tube is stored in a refrigerator at 2-8°C/36-46°F, the specimen can be used for testing within 1-2 days after collection.
3. Do not use hemolyzed blood Specimens.
CAUTION
• As known relevant interference, hemolytic Specimen, rheumatoid factors-contained Specimen and lipemic, icteric Specimen can lead to impair
the test results.
• Use separate disposable materials for each Specimen in order to avoid cross-contamination which can cause erroneous results.
PERFORMANCE CHARACTERISTICS
[Clinical evaluation]
Performance characteristic for the STANDARD Q COVID-19 IgM/IgG Duo Test for rapid detection of anti-SARS-CoV-2 antibodies was established in retrospective, multi-center,
randomized, single-blinded study conducted at a trial site in KOREA during the 2020 SARS-CoV-2 pandemic situation. A total of 504 retrospective specimens were tested using
the STANDARD Q COVID-19 IgM/IgG Duo Test. These specimens consisted of serum from PCR positive or negative confirmed patients. The performance of the STANDARD
Q COVID-19 IgM/IgG Duo Test were compared to a commercialized molecular assay. Although the STANDARD Q COVID-19 IgM/IgG Duo Test allows to test for IgM and IgG
separately, due to the differing inter-patient time response to the virus, any individual with positive result for the IgM or the IgG test should be read as a positive for anti-SARSCoV-
2 antibodies. The combined test result (positive for IgM and/or IgG or negative for IgM and/or IgG) was used to calculate the total test sensitivity and specificity.
• Test sensitivity
The seroconversion time of IgM and IgG antibodies varies from person to person, but it was estimated to be around 7 days after onset of symptom4, 5. The STANDARD Q
COVID-19 IgM/IgG Duo Test showed 94.33% of sensitivity using specimens from patients 7 days after symptom onset (combined IgM+IgG).
Table 1. Summary of the sensitivity of the STANDARD Q COVID-19 IgM/IgG Duo Test compared to PCR using specimens 7 days after symptom onset.
≥ 7 days after symptom onset
PCR
Positive Negative Total
STANDARD Q COVID-19
IgM/IgG Duo Test
Positive 183 0 183
Negative 11 0 11
Total 194 0 194
Sensitivity 94.33%
(183/194, 95% CI, 90.08% - 97.14%)
Table 2. Summary of the sensitivity of the STANDARD Q COVID-19 IgM/IgG Duo Test compared to PCR using specimens within less than 7 days after symptom onset.
< 7 days after symptom onset
PCR
Positive Negative Total
STANDARD Q COVID-19
IgM/IgG Duo Test
Positive 31 0 31
Negative 14 0 14
Total 45 0 45
Sensitivity 68.89%
(31/45, 95% CI, 53.35% - 81.83%)
Table 3. Summary of the sensitivity of the STANDARD Q COVID-19 IgM/IgG Duo Test compared to PCR using specimens in the period of 7 days to 14 days after
symptom onset.
7-14 days after symptom onset
PCR
Positive Negative Total
STANDARD Q COVID-19
IgM/IgG Duo Test
Positive 73 0 73
Negative 10 0 10
Total 83 0 83
Sensitivity 87.95%
(73/83, 95% CI, 78.96% - 94.07%)
Table 4. Summary of the sensitivity of the STANDARD Q COVID-19 IgM/IgG Duo Test compared to PCR using specimens 14 days after symptom onset.
> 14 days after symptom onset
PCR
Positive Negative Total
STANDARD Q COVID-19
IgM/IgG Duo Test
Positive 110 0 110
Negative 1 0 1
Total 111 0 111
Sensitivity 99.10%
(110/111, 95% CI, 95.08% - 99.98%)
• Test Specificity
The STANDARD Q COVID-19 IgM/IgG Duo Test showed 95.09% of specificity (combined IgM+IgG).
Table 5. Summary of the specificity of the STANDARD Q COVID-19 IgM/IgG Duo Test compared to PCR.
PCR
Positive Negative Total
STANDARD Q COVID-19
IgM/IgG Duo Test
Positive 0 13 13
Negative 0 252 252
Total 0 265 265
Specificity 95.09%
(252/265, 95% CI, 91.76% - 97.36%)
ANALYTICAL PERFORMANCE
1. Limit of Detection: IgM-0.02 mg/ml, IgG-0.02 mg/ml
2. Cross-Reactivity: No cross-reactivity for HIV positive plasma, Japanese Encephalitis positive plasma, Zika virus positive plasma, Chikungunya positive plasma, Dengue IgM
positive plasma, Salmonella typhi IgM positive plasma, Rubella IgM, CMV IgG/IgM, Tick borne encephalitis IgM positive plasma, West Nile Virus positive plasma, Treponema
palladium, HAV IgM positive plasma, HAV IgG positive plasma, HBV Ab positive plasma, HCV Ab positive plasma, Influenza vaccine positive plasma, Leishmania positive
plasma, Brucella IgM positive plasma, Chagas positive plasma, Toxoplasma positive plasma and Filariasis positive plasma for IgM and IgG
3. Interference study: No Interference for Respiratory Specimens (Mucin: bovine submaxillary gland type I-S, Blood (human), EDTA anticoagulated, Biotin), Nasal sprays (Neo-
Synephrine, Afrin Nasal Spray, Saline Nasal Spray), Homeopathic allergy relief medicine (Homeopathic Zicam Allergy Relief Nasal Gel, Sodium Cromoglycate, Olopatadine
Hydrochloride), Anti-viral drugs (Zanamivir, Oseltamivir, Artemether-lumefantrine, Doxycycline hyclate, Quinine, Lamivudine, Ribavirin, Daclatasvir), Anti-inflammatory
medication (Acetaminophen, Acetylsalicylic acid, Ibuprofen), Antibiotic (Mupirocin, Tobramycin, Erythromycin, Ciprofloxacin), Human anti-mouse antibody, Pregnant woman,
Elevated levels of C-reactive protein for IgM and IgG
4. High-dose Hook Effect: No hook effect at the concentration of 1.25 mg/ml for IgM and 0.3 mg/ml for IgG
5. Matrix Equivalency: The difference of Matrix (Capillary whole blood, Venous whole blood, Plasma, Serum) and anticoagulant (EDTA, Heparin, Sodium citrate) does not affect the result.
Sort Matrix Anticoagulant Spiked Concentration Agreement to expected result
COVID-19 IgM antibody
spiked
Serum NA 0.04 mg/ml 100%(30/30)
Plasma
Heparin 0.04 mg/ml 100%(30/30)
EDTA 0.04 mg/ml 100%(30/30)
Sodium Citrate 0.04 mg/ml 100%(30/30)
Venous whole blood
Heparin 0.04 mg/ml 100%(30/30)
EDTA 0.04 mg/ml 100%(30/30)
Sodium Citrate 0.04 mg/ml 100%(30/30)
Capillary whole blood EDTA 0.04 mg/ml 100%(30/30)
COVID-19 IgG antibody
spiked
Serum NA 0.04 mg/ml 100%(30/30)
Plasma
Heparin 0.04 mg/ml 100%(30/30)
EDTA 0.04 mg/ml 100%(30/30)
Sodium Citrate 0.04 mg/ml 100%(30/30)
Venous whole blood
Heparin 0.04 mg/ml 100%(30/30)
EDTA 0.04 mg/ml 100%(30/30)
Sodium Citrate 0.04 mg/ml 100%(30/30)
Capillary whole blood EDTA 0.04 mg/ml 100%(30/30)
N/A
Serum NA N/A 100%(30/30)
Plasma
Heparin N/A 100%(30/30)
EDTA N/A 100%(30/30)
Sodium Citrate N/A 100%(30/30)
Venous whole blood
Heparin N/A 100%(30/30)
EDTA N/A 100%(30/30)
Sodium Citrate N/A 100%(30/30)
Capillary whole blood EDTA N/A 100%(30/30)
6. Stability schedule for 24months of claimed shelf life
1) Accelerated stability Test: March, 2020 ~ July, 2020 (for 19 weeks)
2) Real time stability Test: March, 2020 ~ May, 2022 (for 26 months)
LIMITATION OF TEST
1. The test procedure, precautions and interpretation of results for this test must be followed strictly when testing.
2. This test detects the presence of SARS-CoV-2 IgM/IgG in the specimen and should not be used as the sole criteria for the diagnosis of SARS-CoV-2 infection.
3. Test results must be considered with other clinical data available to the physician.
4. For more accuracy of immune status, additional follow-up testing using other laboratory methods is recommended.
5. Neither the quantitative value nor the rate anti- SARS-CoV-2 IgM/IgG concentration can be determined by this qualitative test.
6. Failure to follow the test procedure and interpretation of test results may adversely affect test performance and/or produce invalid results.
EXTERNAL QUALITY CONTROL
1. Positive and negative controls are optional contents (Cat No. 10COVC20) and these controls can be provided as a means on additional quality control to demonstrate a positive
or negative reaction.
2. Quality controls should be treated and tested the same as patient specimens.
NOTIFICATION FOR COVID-19 ANTIBODY TESTS
1. This test has not been reviewed by the FDA.
2. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be
considered to rule out infection in these individuals.
3. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
4. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E or past or present infection
with SARS virus (no. 6).
5. Not for the screening of donated blood.
6. The test procedure should be conducted in ambient temperature and pressure.
7. Results of these tests should be appropriately recorded in a test report.
BIBLIOGRAPHY
1. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected. Interim guidance. WHO.2020
2. Diagnostic detection of Wuhan coronavirus 2019 by real-time RT-PCR.2020
3. Diagnosis and treatment of pneumonia caused by new coronavirus (trial version 4) National Health Commission. 2020
4. Guo L et al. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clinical Infectious Disease. 2020
5. Zhao J et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clinical Infectious Disease. 2020
Manufactured by
Head office : C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA
Manufacturing site : 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161,
REPUBLIC OF KOREA
Authorized Representative
Altenhofstrasse 80 66386 St. Ingbert Germany
Phone : +49 6894 581020, Fax : +49 6894 581021
Any inquiries regarding instructions provided should be addressed to: sales@sdbiosensor.com
or you can also contact us through www.sdbiosensor.com
L23COV12ENR2
Issue date: 2020.04
Reference number In vitro Diagnos????cs Do not re-use.
To indicate the temperature limita????ons in
which the transport package has to be
kept and handled.
Consult Instruc????ons for Use Contains Sufficient for Tests Cau????on Note Use by Batch code Manufacturer Date of manufacture Indicate that you should keep the product dry Keep away from sunlight Do not use if packaging is damaged