ec declaration of conformity - cloudinary

EC DECLARATION OF CONFORMITY According to the In Vitro Diagnostic Medical Devices Directive 98/79/EC

This is to certify that: Suresign Professional COVID-19 Antigen Rapid Test

(Oral Fluid)

(Product Code 00550)

Has been classified as: General IVD, Non Annex II, Non Self-Test Device

Manufactured By: CIGA Healthcare Ltd, Kilgran House, 27 Kildowney Road

Ballymena, BT44 9EY, United Kingdom

Conformity Assessment Route: Annex III sections 2 to 5 excluding section 6

Notified Body Details N/A

GMDN Code: 64756

Intended Use:

CIGA Healthcare Ltd.’s Suresign Professional COVID-19 Antigen Rapid Test (Oral Fluid) (00550) is a rapid chromatographic

immunoassay for the qualitative detection of SARS-CoV-2 antigens present in human Oral Fluid specimens from individuals with

suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. The COVID-19

Antigen Rapid Test (Oral Fluid) is intended for professional in vitro diagnostic use only.

1. Complies with all Essential Requirements (Annex I) of the In Vitro Diagnostic Medical Devices Directive 98/79/EC. This

compliance has been properly documented and covers the items listed in Annex I of the Directive.

2. The undersigned declares to fulfil the obligations imposed by Annex III section 2 to 5 excluding section 6.

a. Availability of the technical documentation in Annex III (section 3) allowing the assessment of the conformity of the

product with the requirements of the Directive

b. The manufacturer shall take the necessary measures to ensure that the manufacturing process follows the principles

of quality assurance as appropriate for the products manufactured (Annex III section 4)

c. The manufacturer shall institute and keep up to date a systematic procedure to review experience gained for devices

in post-production phase and to implement appropriate means to apply any necessary corrective actions (Annex III

section 5)

3. CIGA Healthcare Ltd has a quality system in place based on ISO13485:2016

4. Conformity of the device complies with, the following Harmonised standards

EN ISO 13485:2016, EN ISO 14971:2012, EN ISO18113-1:2011, EN ISO18113-2:2011, EN 13641:2002,

EN ISO 13612:2002, EN ISO 23640:2015, EN ISO 17511:2003, EN 13975:2003, EN ISO 15223-1 2016

5. This Declaration of Conformity is signed on behalf of CIGA Healthcare Ltd certifying that the requirements of Annex I and

Annex III have been met and documented.

27 January 2021

___________________________ ___________________________

Mr Irwin Armstrong

CEO CIGA Healthcare Ltd Date

CERTIFICATE OF REGISTRATION

File Number A18092 Cycle StartDate

August 9, 2018Certificate Number 1721.201209 Effective Date December 9, 2020

Initial Issue Date August 9, 2018 Expiry Date August 8, 2021

This quality system registration is included in UL’s Directory of Registered Firms and applies to the provision ofgoods and/or services as specified in the scope of registration from the address(es) shown above. By issuance ofthis certificate the firm represents that it will maintain its registration in accordance with the applicablerequirements. This certificate is not transferable and remains the property of UL LLC.

UL LLC333 Pfingsten Road

Northbrook, IL 60062-2096 USA

00-MB-F0866 Issue 2.0 UL and the UL logo are trademarks of Underwriters Laboratories Inc. © 2018

CIGA Healthcare LtdKilcran House27 Kildowney RoadBallymena BT44 9EY UNITED KINGDOM

UL LLC®(UL) issues this certificate to the Firm named above, after assessing the Firm’s quality systemand finding it in compliance with:

ISO 13485:2016EN ISO 13485:2016The Manufacture of in-vitro diagnostic medical devices for the detection of abnormal urine parameters for homeuse The Manufacture of in-vitro diagnostics medical devices for COVID-19 IgG/IgM Rapid antibody tests forprofessional use The Packaging and Distribution of in-vitro diagnostics medical devices for the detection ofovulation and pregnancy for home use The Distribution of thermometers for the measurement of bodytemperature and of blood pressure monitors for the measurements of blood pressure for use in home caremedicine

Certificate with Addendum(s) totals 2 pages.

Authorized by

Deborah Jennings-ConnerGlobal Regulatory Director

Life and Health Sciences, UL LLC

Check CertificateStatus: here

CERTIFICATE OF REGISTRATION

CIGA Healthcare LtdKilcran House27 Kildowney RoadBallymena BT44 9EY UNITED KINGDOM

Addendum 1

File Number A18092 Cycle StartDate

August 9, 2018Certificate Number 1721.201209 Effective Date December 9, 2020

Initial Issue Date August 9, 2018 Expiry Date August 8, 2021

This quality system registration is included in UL’s Directory of Registered Firms and applies to the provision ofgoods and/or services as specified in the scope of registration from the address(es) shown above. By issuance ofthis certificate the firm represents that it will maintain its registration in accordance with the applicablerequirements. This certificate is not transferable and remains the property of UL LLC.

UL LLC333 Pfingsten Road

Northbrook, IL 60062-2096 USA

00-MB-F0866 Issue 2.0 UL and the UL logo are trademarks of Underwriters Laboratories Inc. © 2018

2-1Unit C1, Pennybridge Industrial EstateBallymena, N. Ireland BT42 3HB UNITED KINGDOM

Performing: The manufacture of in-vitro diagnostic medical devices used in the detection of ovulation,pregnancy,and abnormal urine parameters.The manufacture of medical thermometers and blood pressure monitors.

Mr. Gavin McCarley CIGA Healthcare Ltd Kilcran House, 27 Kildowney Road, Ballymena BT44 9EY UNITED KINGDOM July 21st, 2020 Subject: ISO13485 certification scope expansion request for inclusion of

Covid-19 related product manufacturing Dear Sirs UL confirm that CIGA Healthcare Ltd  have notified us that they are starting final pack operations for manufacture of professional use COVID-19 / 2019-n CoV IgG/IgM Rapid TestS  (whole blood, serum and plasma) for an existing CE marked kit and that we have received the necessary forms to proceed with audit for the scope expansion of quality management system certifications to cover these additional manufacturing activities.   It is our intention to have completed all the necessary audits within 3-4 months to enable us to add these activities to their ISO 13485:2016 certification scope, subject to satisfactory audit and review. Regards Paul Daysh Maurizio La Mura

Operations Manager IVD Specialist and Lead Auditor UL LHS Regulatory UL LHS Regulatory

COVID-19 ANTIGEN RAPID TEST (ORAL FLUID)

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Table of Contents

1 BACKGROUND ....................................................................................................................... 2 1.1 Test Principle ................................................................................................................................................... 2 1.2 Illustrations ..................................................................................................................................................... 2 1.3 Performance and Specification ....................................................................................................................... 3 1.4 Precautions ..................................................................................................................................................... 3 1.5 Storage and Stability ....................................................................................................................................... 3 1.6 Specimen Collection and Preparation ............................................................................................................. 3 1.7 Standard Testing Procedure ............................................................................................................................ 3 1.8 Interpretation of Results ................................................................................................................................. 4 1.9 Quality Control ................................................................................................................................................ 4 1.10 Limitations .................................................................................................................................................... 5 1.11 Description of Test Methods ......................................................................................................................... 5

1.11.1 General remarks ...................................................................................................................................................... 5

1.11.2 Receiving inspection and control of raw materials .................................................................................................. 6

1.12 Composition of Product ................................................................................................................................ 6 1.13 Manufacturing Procedure ............................................................................................................................. 6

2 PERFORMANCE CHARACTERISTICS ............................................................................................... 7 2.1 Sample Correlation ......................................................................................................................................... 7 2.2 Detection Level Determination ....................................................................................................................... 8 2.3 Interfering Substances .................................................................................................................................... 9 2.4 Cross Reactivity .............................................................................................................................................. 11 2.5 Specificity Testing with Strains ...................................................................................................................... 12 2.6 Dose Hook Study ........................................................................................................................................... 13 2.7 Variability (Inter/Intra/Day to day assay) ..................................................................................................... 14 2.8 Reading Time Flex Study ............................................................................................................................... 15 2.9 Specimen Volume Flex Study ......................................................................................................................... 17 2.10 Open Pouch Stability Study ......................................................................................................................... 18 2.11 Accelerated Stability Study ......................................................................................................................... 21

3 BIBLIOGRAPHY .................................................................................................................... 24

Figure 1 : Test Principle ................................................................................................................................................... 2

COVID-19 ANTIGEN RAPID TEST(ORAL FLUID)

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1 BACKGROUND

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

1.1 Test Principle

The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Antigens in human Oral Fluid specimen. SARS-CoV-2 antibody is coated in the test line region. During testing, the specimen reacts with SARS-CoV-2 antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2 antibody in test line region. If the specimen contains SARS-CoV-2 Antigens, a colored line will appear in test line region as a result of this. If the specimen does not contain antigens to SARS-CoV-2, no colored line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

1.2 Illustrations

Figure 1: Test Principle

As shown in illustration above, the specimen (A) migrates via capillary action along the membrane to react with the colored conjugate (B). COVID-19 antigen present in the specimen binds to the conjugate, forming a colored antibody-antigen complex. The anti-COVID-19 immobilized in the test zone of the membrane captures the test region (C). The formation of a visible colored line in the test region indicates a positive result (C). The absence of a colored line in the test zones suggests a negative result. In the control zone of the membrane, immobilized reagents capture colored conjugate regardless of test specimen composition. The resulting visible colored band (D) confirms control line.

A B C D


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1.3 Performance and Specification

COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of s SARS-CoV-2 antigens present in human oral fluid.

1.4 Precautions

z This package insert must be read completely before performing the test. Failure to follow directions in package insert may yield inaccurate test results.

z For professional in vitro diagnostic use only. Do not use after expiration date. z Do not eat, drink or smoke in the area where the specimens or kits are handled. z Do not use test if pouch is damaged. z Handle all specimens as if they contain infectious agents. Observe established precautions

against microbiological hazards throughout in the collection, handling, storage, and disposal of patient samples and used kit contents.

z Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

z Wash hands thoroughly after handling. z Please ensure that an appropriate amount of samples are used for testing. Too much or too

little sample size may lead to deviation of results. z Extracted specimens for PCR tests or Viral Transport Media (VTM)cannot be used for the test. z The used test should be discarded according to local regulations. z Humidity and temperature can adversely affect results.

1.5 Storage and Stability

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

1.6 Specimen Collection and Preparation

The oral fluid specimen should be collected using the collector provided with the kit. Follow the detailed Directions for Use below. No other collection cassettes should be used with this assay. Oral fluid collected at any time of the day may be used.

1.7 Standard Testing Procedure

Allow the test device, collection device, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.


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1. Specimen Collection

Important: Before collecting oral fluid relax your cheeks and gently massage cheeks with fingers for 15-30 seconds, place the tongue against the upper and lower jaws and roots to enrich the oral fluid.

z Remove the collection device and collect Approx. 500μl oral fluid specimen. If there’s not enough oral fluid collected, repeat the above specimen collection steps.

2. Specimen Extraction

z Mix the buffer (Approx. 500μl) with the collected oral fluid. Gently shake the mixture for 10 seconds. NOTE: The storage of the specimen after extraction is stable for 2 hours at room temperature or 24 hours at 2-8°C.

3. Test Reaction

Remove the test device from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

z Add Extracted specimen to the Test Device, Wait for the colored line(s) to appear. Read the result at 15 minutes. Do not interpret the result after 20 minutes. Refer to the Procedure Card for detailed information of the testing procedure.

1.8 Interpretation of Results

POSITIVE:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the Test region (T). Positive result in the Test region indicates detection of SARS-COV-2 antigens in the sample. *NOTE: The intensity of the color in the test line region (T) will vary based on the amount of SARS-COV-2 antigen present in the sample. So any shade of color in the test region (T) should be considered positive. NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test line region (T). INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

1.9 Quality Control

1.9.1 Internal Quality Control Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative procedural control. If


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the test is working properly, the background in the result area should be white to light pink and not interfere with the ability to read the test result. 1.9.2 External Quality Control Positive/negative controls are not included in this kit. However, in compliance with Good Laboratory Practice (GLP), these controls are recommended.1

1.10 Limitations

z The test Procedure and the Interpretation of test Result must be followed closely when testing for the presence of SARS-CoV-2 antigens in the human oral fluid specimens from suspected individuals. For optimal test performance, proper sample collection is critical. Failure to follow the procedure may give inaccurate results.

z The performance of the COVID-19 Antigen Rapid Test (oral fluid) was evaluated using the procedures provided in this product insert only. Modifications to these procedures may alter the performance of the test. Viral Extracted specimens for PCR tests or Viral Transport Media (VTM) can not be used for the test.

z The COVID-19 Antigen Rapid Test (oral fluid) is for in vitro diagnostic use only. This test should be used for detection of SARS-CoV-2 Antigens in human oral fluid specimens as an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Neither the quantitative value nor the rate of increase in the concentration of SARS-CoV-2 antigens can be determined by this qualitative test.

z The COVID-19 Antigen Rapid Test (oral fluid) will only indicate the presence of SARS-CoV-2 Antigens in the specimen and should not be used as the sole criteria for the diagnosis of SARS-CoV-2 infections.

z The results obtained with the test should be considered with other clinical findings from other laboratory tests and evaluations.

z If the test result is negative or non-reactive and clinical symptoms persist. It is recommended to re-sample the patient a few days later and test again or test with a molecular diagnostic device to rule out infection in these individuals.

z The test will show negative results under the following conditions: The titer of the novel coronavirus antigens in the sample is lower than the minimum detection limit of the test.

z 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.

z Positive results of COVID-19 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interference factors.

1.11 Description of Test Methods

1.11.1 General remarks The Quality Control department performs testing according to written procedures. Testing


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equipment is checked prior to use and calibrated at scheduled frequencies. 1.11.2 Receiving inspection and control of raw materials A sample batch of each raw material (chemicals, packaging and labeling) is inspected/tested (where applicable) for suitability and functionality. Primary packaging is inspected for correct dimensions, cleanliness and suitability. Only QC “APPROVED” raw material is employed for production.

1.12 Composition of Product

A) Goat anti-mouse IgG B)Mouse IgG

C) Anti-SARS-CoV2 Antibody for capture D) Anti-SARS-CoV2 Antibody for detection

E) Absorbent pad F) Membrane

G) Adhesive plastic backing H) Plastic cassette

I) Sample pad J) Label pad

K)Pouch L) Desiccant

M)Extraction Buffer N) Package insert

O) Collection Devices Q)Procedure Card

P) Biosafety Bags

1.13 Manufacturing Procedure

z Coat the conjugated Anti-SARS-CoV2 antibody and Mouse IgG on the label pad. z Use the sprayer to dispense Anti-SARS-CoV2 antibody and Goat anti-mouse IgG on the

membrane. z Assemble the membrane, label pad, absorbent pad and sample pad on the plastic backing. z Use the cutter to cut the plastic backing into strips of selected size. And/or lay the strip into

the plastic cassette. z Pack the cassette and a desiccant packet into a pouch and seal the pouch. z Test the cassette according to the QC procedure and release the finished product.


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2 PERFORMANCE CHARACTERISTICS

2.1 Sample Correlation

The COVID-19 Antigen Rapid Test (Oral Fluid) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for the COVID-19 Antigen Rapid Test (Oral Fluid). Specimens were considered positive if RT-PCR indicated a positive result. Specimens were considered negative if RT-PCR indicated a negative result. Materials z COVID-19 Antigen Rapid Test Cassette Lot: COV20080001-T z 36 COVID-19 clinical positive specimen z 500 COVID-19 clinical negative specimen

Table: Sample Correlation Results of Test Cassette

Oral Fluid Specimen

COVID-19 Antigen Rapid Test RT-PCR

Total Positive Negative

COVID-19 Antigen

Positive 34 4 38 Negative 2 496 498

Total 36 500 536 Relative Sensitivity 94.4% (95%CI*: 81.3%~99.3%) Relative Specificity 99.2% (95%CI*: 98.0%~99.8%)

Accuracy 98.9% (95%CI*: 97.6%~99.6%) Conclusion: The relative sensitivity of COVID-19 Antigen Rapid Test Cassette was 94.4%, the relative specificity was 99.2% compare with PCR result.


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2.2 Detection Level Determination

A recombine COVID-19 protein was diluted with negative saliva to a low concentration to determine detection level. The assays were performed according to the package insert.

Specimens ICOV-802

COV20080001-T COV20080002-T COV20080003-T 15min 15min 15min

100ng/ml + + + + + + + + + 10ng/ml + + + + + + + + + 1ng/ml + + + + + + + + + 500pg/ml + + + + + + + + + 200pg/ml + + + + + + + + + 100pg/ml + + + + + + + + + 50pg/ml - + - - + - + - - Negative - - - - - - - - - Note:“+” mean positive result, “-” mean negative result Conclusion: Minimal detection limits of COVID-19 Antigen Rapid Test is 100pg/ml for recombine COVID-19 protein.


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2.3 Interfering Substances

The interfering substances below were spiked with negative and SARS-COV-2 Antigen weak positive. Test them according to the package insert in triplicate. Read the result at 15 minutes. Results were present in table below.

Table: Interfering Substances

Analytes Conc. COV20080001-T

Negative SARS-COV-2 Antigen

weak Positive Dexamethasone 0.8mg/ml - - - + + +

Mucin 50μg/ml - - - + + + Flunisolide 6.8ng/ml - - - + + + Mupirocin 12mg/ml - - - + + +

Oxymetazoline 0.6mg/ml - - - + + + Phenylephrine 12mg/ml - - - + + +

Rebetol 4.5μg/ml - - - + + + Relenza 282ng/ml - - - + + + Tamiflu 1.1μg/ml - - - + + +

Tobryamycin 2.43mg/ml - - - + + + Tea 33.3mg/ml - - - + + + Milk 11.2% - - - + + +

Orange juice 100% - - - + + + Mouthwash 2% - - - + + +

Caffeine 1mg/ml - - - + + + CocaCola / - - - + + +

Toothpaste / - - - + + +








Orange juice 100% - - - + + +


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Mouthwash 2% - - - + + + Caffeine 1mg/ml - - - + + + CocaCola / - - - + + +

Toothpaste / - - - + + +








Orange juice 100% - - - + + + Mouthwash 2% - - - + + +

Caffeine 1mg/ml - - - + + + CocaCola / - - - + + +

Toothpaste / - - - + + + Note: “-” mean negative result, “+” mean positive result Conclusion: No substances showed any interference with the test. There were no obvious differences among the 3 lots of products.


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2.4 Cross Reactivity

1E+08org/ml following samples were spiked into oral fluid and tested according to the package insert in triplicate. Read the results at 15 minutes. Results were presented in table below. Arcanobacterium Concentration: 1E+08org/ml Candida albicans Concentration: 1E+08org/ml Corynebacterium Concentration: 1E+08org/ml Escherichia coli Concentration: 1E+08org/ml Moraxella catarrhalis Concentration: 1E+08org/ml Neisseria lactamica Concentration: 1E+08org/ml Nesseria subllava Concentration: 1E+08org/ml Pseudomonas aeruginosa Concentration: 1E+08org/ml Staphylococcus aureus subspaureus Concentration: 1E+08org/ml Staphylococcus epidermidis Concentration: 1E+08org/ml Streptococcus pneumoniae Concentration: 1E+08org/ml Streptococcus pygenes Concentration: 1E+08org/ml Streptococcus salivarius Concentration: 1E+08org/ml Streptococcus sp group F Concentration: 1E+08org/ml

Table: Cross Reactivity Result

Treatment ICOV-802

COV20080001-T COV20080002-T COV20080003-T 15 minutes 15 minutes 15 minutes

Arcanobacterium - - - - - - - - - Candida albicans - - - - - - - - - Corynebacterium - - - - - - - - - Escherichia coli - - - - - - - - -

Moraxella catarrhalis - - - - - - - - - Neisseria lactamica - - - - - - - - - Nesseria subllava - - - - - - - - -

Pseudomonas aeruginosa - - - - - - - - - Staphylococcus aureus

subspaureus - - - - - - - - -

Staphylococcus epidermidis - - - - - - - - - Streptococcus pneumoniae - - - - - - - - -

Streptococcus pygenes - - - - - - - - - Streptococcus salivarius - - - - - - - - -

Streptococcus sp group F - - - - - - - - - Note: “-” mean negative result Conclusion: There was no cross-reaction with the above substances when COVID-19 Rapid Test(Oral Fluid) tested at 15 minutes.


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2.5 Specificity Testing with Strains

Following strains at specified concentrations were spiked into oral fluid and tested according to the package insert. Read the results at 15 minutes. Results were presented in table below.

Table: Specificity Testing with Strains

Description Concentration Result

COV20080001-T

COV20080002-T

COV20080003-T

Adenovirus type 3 3.16 x 104 TCID50/ml - - -

Adenovirus type 7 1.58 x 105 TCID50/ml - - - Human

coronavirus OC43 1 x 106 TCID50/ml - - -

Human coronavirus 229E

5 x 105 TCID50/ml - - -

Human coronavirus NL63

1 x 106 TCID50/ml - - -

Human coronavirus HKU1

1 x 106 TCID50/ml - - -

Influenza A H1N1 3.16 x 105 TCID50/ml - - - Influenza A H3N2 1 x 105 TCID50/ml - - -

Influenza B 3.16 x 106 TCID50/ml - - - Measles 1.58 x 104 TCID50/ml - - - Mumps 1.58 x 104 TCID50/ml - - -

Parainfluenza virus 2

1.58 x 107 TCID50/ml - - -

Parainfluenza virus 3

1.58 x 108 TCID50/ml - - -

Respiratory syncytial virus

8.89 x 104 TCID50/ml - - -

Note:“-” mean negative result TCID50 = Tissue Culture Infectious Dose is the dilution of virus that under the conditions of the assay can be expected to infect 50% of the culture vessels inoculated. Conclusion: All the results showed negative when tested with different strains at the concentration above.


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2.6 Dose Hook Study

A recombineCOVID-19protein was diluted with negative saliva to 100ug/ml, 10ug/ml, 1ug/ml, 100ng/ml, 10ng/ml, 1ng/ml, 100pg/ml, 50pg/ml and 1pg/ml and tested according to the package insert in replicates of three. The results were rated at 15 minutes. Results were presented in Table below. Table: Dose Hook Study Result

Specimens ICOV-802

COV20080001-T COV20080002-T COV20080003-T 15min 15min 15min

100ug/ml + + + + + + + + + 10ug/ml + + + + + + + + + 1ug/ml + + + + + + + + + 100ng/ml + + + + + + + + + 10ng/ml + + + + + + + + + 1ng/ml + + + + + + + + + 100pg/ml + + + + + + + + + 50pg/ml - - - + - - - - - 1pg/ml - - - - - - - - - Negative - - - - - - - - - Note: “+” mean positive result, “-” mean negative result. Conclusion: Test results showed that there was no dose hook effect toCOVID-19 Antigen Rapid Test (Oral Fluid).


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2.7 Variability (Inter/Intra/Day to day assay)

Negative, SARS-COV-2 Antigen Weak Positive, SARS-COV-2 Antigen Strong Positive were tested according to the package inset. Ten replicates of each level were tested each day for 3 consecutive days using all the 3 lots. Read the results at 15 minutes. Results were presented in Table below.

Table: Variability Results Negative (Dilution)

Day Lot#: 1 2 3 4 5 6 7 8 9 10

Day 1 COV20080001-T - - - - - - - - - - COV20080002-T - - - - - - - - - - COV20080003-T - - - - - - - - - -



SARS-COV-2 Antigen Weak Positive Day Lot#: 1 2 3 4 5 6 7 8 9 10

Day 1 COV20080001-T + + + + + + + + + + COV20080002-T + + + + + + + + + + COV20080003-T + + + + + + + + + +



SARS-COV-2 Antigen Strong Positive Day Lot#: 1 2 3 4 5 6 7 8 9 10




Note: “-” mean negative result, “+” mean positive result Conclusion: Test results were consistent between three lots of test cassette.


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2.8 Reading Time Flex Study

Negative, SARS-COV-2 Antigen weak positive, and SARS-COV-2 Antigen strong positive standards have been tested according to the directions for use in replicates of three. The test was rated as positive or negative at 3, 5, 10, 15, 20, 30minutes, 1 hour and 2 hours.

Table: Reading Time Flex Study Result

Time Lot 1: COV20080001-T

Negative SARS-COV-2 Antigen weak positive

SARS-COV-2 Antigen strong positive

3min - - - - - - + + + 5min - - - - - + + + +

10min - - - + + + + + + 15min - - - + + + + + + 20min - - - + + + + + + 30min - - - + + + + + +

1 h - - - + + + + + + 2hs - - - + + + + + +




3min - - - - - - + + + 5min - - - - + + + + +

10min - - - + + + + + + 15min - - - + + + + + + 20min - - - + + + + + + 30min - - - + + + + + +

1 h - - - + + + + + + 2hs - - - + + + + + +




3min - - - - - - + + + 5min - - - - + - + + +

10min - - - + + + + + + 15min - - - + + + + + + 20min - - - + + + + + + 30min - - - + + + + + +

1 h - - - + + + + + + 2hs - - - + + + + + +

Note: “-” mean negative result, “+” mean positive result


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Conclusion: This study demonstrated the ability of the assay to give correct results with the prescribed read time of 15 minutes. For the samples tested, the result remained consistent within one hour period.


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2.9 Specimen Volume Flex Study

Negative, SARS-COV-2 Antigen weak positive spiked extraction reagent were added into the sample well of COVID-19 Antigen Rapid Test with the following operation method, read the results at 15 minutes , a suitable specimen volume should be validated in this study. Method A- 1 drops specimen Method B- 2 drops specimen Method C- 3 drops specimen Method D- 4 drops specimen Method E- 5 drops specimen

Table: Specimen Volume Flex Study Result

Lot Method A B C D E

Specimen 15min 20min 15min 20min 15min 20min 15min 20min 15min 20min

COV

2008

0001

-T

Negative - - - - - - - - x - - - - - - - - - - - - x - - - - - - - -

SARS-COV-2

Antigen weak

positive

+ + + + + + + + + x + + + + + + + + + +

+ + + + + + + + + +

COV

2008

0002

-T

Negative - - - - - - - - - - - - - - - - - - - x - - - - - - - - x -

SARS-COV-2

Antigen weak

positive

x + + + + + + + + + + + + + + + + + + +

+ + + + + + + + + +

COV

2008

0003

-T

Negative - - - - - - - - - - - - - - - - - - x - - - - - - - - - - -

SARS-COV-2

Antigen weak

positive

+ + + + + + + + + + + + + + + + + + + +

+ + + + + + + + + x

Note: “-” mean negative result, “+” mean positive result, “x” mean abnormalresults Conclusion: This study demonstrated the ability of the assay to give correct results with 2~4 drops specimen volume.


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2.10 Open Pouch Stability Study

Negative, SARS-COV-2 Antigen weak positive and SARS-COV-2 Antigen strong positive specimen were run in triplicate using the COVID-19 Antigen Rapid Test(Oral Fluid) which were opened pouch after 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours and 2 hours at following condition. All results were read as positive or negative at 15 and 20 minutes after sample application. Condition 1: Room temperature and high humidity (≥90%) Condition 2: 45℃ and normal humidity (≤60%) Condition 3: 45℃and high humidity (≥90%) Condition 4: Room temperature and normal humidity (≤60%)

Table: Open Pouch Stability Study Results

Sample Time after

Open Pouch (Minutes)

Results of Condition 1

COV20080001-T COV20080002-T COV20080003-T

Negative

10min - - - - - - - - - 20min - - - - - - - - - 30min - - - - - - - - - 60min - - - - - - - - - 90min - - - - - - - - -

120min - - - - - - - - -

SARS-COV-2

Antigen weak

positive

10min + + + + + + + + + 20min + + + + + + + + + 30min + + + + + + + + + 60min + + + + + + + + + 90min + + + + + + + + +

120min + + + + + + + + +

SARS-COV-2

Antigen strong

positive


120min + + + + + + + + +

Sample Time after



COV20080001-T COV20080002-T COV20080003-T

Negative


120min - - - - - - - - -


19

SARS-COV-2

Antigen weak

positive


120min + + + + + + + + +

SARS-COV-2

Antigen strong

positive


120min + + + + + + + + +

Sample Time after



COV20080001-T COV20080002-T COV20080003-T

Negative


120min - - - - - - - - -

SARS-COV-2

Antigen weak

positive


120min + + + + + + + + +

SARS-COV-2

Antigen strong

positive


120min + + + + + + + + +

Sample Time after



COV20080001-T COV20080002-T COV20080003-T

Negative


120min - - - - - - - - -


20

SARS-COV-2

Antigen weak

positive


120min + + + + + + + + +

SARS-COV-2

Antigen strong

positive


120min + + + + + + + + + Note: “+”mean positive result, “-”mean negative result. Conclusion: The above results indicate that COVID-19 Antigen Rapid Test(Oral Fluid)has the most effective within 1h after opening the pouch.


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2.11 Accelerated Stability Study

Accelerated Stability of the COVID-19 Antigen Rapid Test (Oral Fluid) was evaluated using samples from three different batches. These were placed in an incubator with the temperature calibrated at 45℃and 55℃. Relative humidity (RH) calibrated at about 60%. A series of stability tests were performed at 0, 7, 14, 21, 28, 35, 42, 56, 77, 84 days for 45℃. About 55℃, some performance study would be tested at 0, 7, 14, 21, 28, 35, 42days according to Arrhenius Plot. See Table in below. Test cassettes were assayed using negative, SARS-COV-2 Antigen weak positive and SARS-COV-2 Antigen strong positive specimens. Testing at each specific time interval consisted of 3 replicates for each specimen. The tests were performed according to the package insert. Results are presented in Table below. Arrhenius Formula: In K=-Ea/RT + In A “K” mean Rate constant “A” mean Arrhenius constant “Ea” mean Activation energy “R” mean Gas constant “T” mean Temperature in Kelvin

Table: Time Line for Accelerated Stability Study Day

Temp. 0 day 7 days

14 days

21 days

28 days

35 days

42 days

56 days

77 days

84 days

45℃ √ √ √ √ √ √ √ √ √ √ 55℃ √ √ √ √ √ √ √ × × ×

Table: 45℃Accelerated Stability Summary

Day Specimen ICOV-802

COV20080001-T COV20080002-T COV20080003-T

0 Negative - - - - - - - - -

Weak positive + + + + + + + + + Strong positive + + + + + + + + +

7 Negative - - - - - - - - -


14 Negative - - - - - - - - -


21 Negative - - - - - - - - -


28 Negative - - - - - - - - -



22

35 Negative - - - - - - - - -


42 Negative - - - - - - - - -


56 Negative - - - - - - - - -


77 Negative - - - - - - - - -


84 Negative - - - - - - - - -


Note: “-” mean negative result, “+” mean positive result Table: 55℃Accelerated Stability Summary

Day Specimen ICOV-802

COV20080001-T COV20080002-T COV20080003-T

0 Negative - - - - - - - - -


7 Negative - - - - - - - - -


14 Negative - - - - - - - - -


21 Negative - - - - - - - - -


28 Negative - - - - - - - - -


35 Negative - - - - - - - - -


42 Negative - - - - - - - - -


Note: “-” mean negative result, “+” mean positive result


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Conclusion: TheCOVID-19 Antigen Rapid Test (oral fluid) was stable at 45℃ for 84 days and at 55℃ for 42 days. These data were plotted on an Arrhenius Plot and the shelf life of this product was determined to be at least 24 months from the date of manufacture.


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3 BIBLIOGRAPHY

1. Westgard JO, Barry PL,Hunt MR, Groth T. A multi-rule Shewhart for quality control in clinical chemistry, Clinical Chemistry 1981;27:493-501


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Document History Summary

Version No.

Date Description Remark

01 2020.11.18 New Document N/A

02 2020.11.25 Update clinical data N/A

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