The novel coronaviruses belong to the β genus.SARS-CoV-2 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coron-avirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more effificiently and effectively.

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SARS-CoV-2 Antigen Rapid Test(Immunochromatography)

SARS-CoV-2 Overview

Rapid testing for SARS-CoV-2 antigen within 15 minutes Facilitates patient treatment decisions quickly Simple, time-saving procedure All necessary reagents provided & no equipment needed High sensitivity and specifificity

Benefifits

Contents• 20 Test cassettes• 20 Sterile swabs• 20 sample extraction tube • 2 Buffer• 1 Package insert

The SARS-CoV-2 Antigen Rapid Test is intended for in vitro qualitative detection to SARS-CoV-2 antigen in human nasopharyngeal swab or oropharyngeal swab samples.

Information Time to result Storage Shelf life Specimen type

InDetail 15 minutes 4-30℃ 12 months nasopharyngeal swab ororopharyngeal swab

Specifification

Intended Use

Performance Characteristics

Test Procedure & InterpretationSpecimen collection Use the nasopharyngeal swab or oropharyngeal swab supplied in the kit.

Nasopharyngeal swab collection method:

For 3seconds

1.The operator holds the swab by the right hand and holds the head of the subject fixedly by left hand. Putting the swab downing backwards the bottom of the nasal cavity and penetrate slowly and gently. Do not overexert to avoid traumatic hemorrhage.2.When the cusp of the swab touching the paries posterior of the pharyngonasal cavity, letting the swab remain in the place for a few seconds (about 3 seconds) and rotating the swab gently for one cycle, and then remove the swab slowly.

1

SARS-CoV-2Antigen Rapid Test

Positive

Positive

Negative

Negative

Total

TotalComparator Method

30

33

31

102

10131

135

104

SARS-CoV-2 Antigen Rapid Test Performance against with Comparator Method(nasopharyngeal swab/oropharyngeal swab)

PPA: 90.91% (95%CI: 76.43%-96.86%)NPA: 99.02% (95%CI: 94.66%-99.83% ) OPA: 97.04% (95%CI: 92.63%-98.84%)

EXPLANATION OF TERMS:PPA: Positive Percent Agreement = True Positives / True Positives + False NegativesNPA: Negative Percent Agreement = True Negatives / True Negatives + False Positives. OPA: Overall Percent Agreement = True Positives + True Negatives / TotalCI: Confidence Interval

Doublenostril

sampling

0.5

0.50.50.50.5

Product Description Specimen Catalog No. Format Kit SizeSARS-CoV-2 Antigen

Rapid Testnasopharyngeal swab or oropharyngeal swab H100G

Collection method of oropharyngeal swab:

Both sides of the pharyngeal tonsils at least 3 times, up and down the posterior pharyngeal wall at least 3 times

1.The head of the person to be collected is slightly tilted and his mouth is wide open, exposing the pharyngeal tonsils on both sides. 2.Wipe the swab across the root of the tongue. Wipe the pharyngeal tonsils on both sides of the person to be collected back and forth with a little force for at least 3 times, and then wipe up and down the posterior pharyngeal wall for at least 3 times.

Sample preparation

Add 500μl (~20 drops) of sample extract to the 0.5 mark of the sampling tube, dip the swab after collecting the sample into the sample extract, make the sample extract fully permeate the swab, rotate and squeeze the swab 10 times, then pull out the swab, and take the stranded liquid as the sample to be tested.

500μl(~ 20 drops)

10 times

Test procedure & interpretation of results

2-3 drops(60μl-80μl)

15 minutes NegativePositive Invalid

CT

CT

CT

CT

CT

2

Cassette 20 Tests/Kit

Ordering Information

0.5

QINGDAO HIGHTOP BIOTECH CO.,LTD. Tel:0086-532-58710705 Fax:0086-532-58710706 E-mail:sales@hightopbio.com Web:www.hightopbio.com

SARS-CoV-2 An�gen Rapid Test (Immunochromatography)

FOR PROFESSIONAL USE ONLY Product Name SARS-CoV-2 An�gen Rapid Test (Immunochromatography) Packing Specifica�on The combina�on form of the product is single casse�e. Intended Use The SARS-CoV-2 An�gen Rapid Test is intended for in vitro qualita�ve detec�on to SARS-CoV-2 an�gen in human nasopharyngeal swab or oropharyngeal swab samples. Test Principle According to the gold immunochromatographic test principle, double an�body sandwich method is used to detect SARS-CoV-2 an�gen in the samples. When the an�gen is contained in the sample, the an�gen binds with the corresponding gold labeled monoclonal an�body 1 and the coated monoclonal an�body 2 at the test line to form a compound and then condenses into a red band, indica�ng a posi�ve result. When the sample does not contain an�gen, complex cannot be formed at the test line, and no red band appears, indica�ng nega�ve result. Regardless of whether the SARS-CoV-2 an�gen is contained in the sample, the gold labeled an�body will bind with the coated an�body at the C line to form a complex and develop color (C line). Components The test line is coated with SARS-CoV-2 monoclonal an�body 2. Gold conjugate pad solid phase SARS-CoV-2 monoclonal an�body 1.The quality control line is coated with goat an�-mouse IgG an�body. Sample extract: Tris(hydroxymethyl)methyl aminomethane buffer with surfactant. Swab and sample extrac�on tube are op�onal. MATERIAL NEEDED BUT NOT PROVIDED 1. Timer 2. Personal protec�ve equipment, such a protec�ve gloves, medical mask, goggles and lab coat. 3. Appropriate biohazard waste container and disinfectants. Storage and Shelf-Life Store as packaged in the sealed pouch at 4-30℃, avoid hot and sunshine, dry place, valid for 12 months. DO NOT FREEZE. Some protec�ve measures should be taken in hot summer and cold winter to avoid high temperature or freeze- thaw. Do not open the inner packaging un�l ready, it must be used in one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity＞60%. Sample Requirement Sample Collec�on Nasopharyngeal swab collec�on method: The operator holds the swab by the right hand and holds the head of the subject fixedly by le� hand. Do not overexert to avoid trauma�c hemorrhage. When the cusp of the swab touching the paries posterior of the pharyngonasal cavity, le�ng the swab remain in the place for a few seconds (about 3 seconds) and rota�ng the swab gently for one cycle,and then remove the swab slowly.Using the same swab, repeat this process for the other nostril to ensure

that an adequate sample is collected from both nasal cavi�es. Collec�on method of oropharyngeal swab: The head of the person to be collected is slightly �lted and his mouth is wide open, exposing the pharyngeal tonsils on both sides. Wipe the swab across the root of the tongue. Wipe the pharyngeal tonsils on both sides of the person to be collected back and forth with a li�le force for at least 3 �mes, and then wipe up and down the posterior pharyngeal wall for at least 3 �mes. Sample preserva�on Samples of human nasopharyngeal swabs and oropharyngeal swabs should be processed as soon as possible a�er sample collec�on. If the test cannot be performed immediately, the sample should be stored in a sealed state, stored at 2℃～8℃ for 8 hours, and stored below -20℃ for 1 month. Long-term storage is not recommended. Sample Treatment Add 500μl (~20 drops) of sample extract to the 0.5 mark of the sampling tube, dip the swab a�er collec�ng the sample into the sample extract, make the sample extract fully permeate the swab, rotate and squeeze the swab 10 �mes, then pull out the swab, and take the stranded liquid as the sample to be tested.

Test Procedure Instruc�ons must be read entirely before taking the test. Leave the reagent and sample at room temperature for 30 minutes before use. Return to room temperature. Do not open the inner packing un�l it is ready. Use it as soon as possible a�er opening the inner packing. 1. Open the tear hole of the aluminum foil bag, take out the test card and lay it flat. 2. Apply 2-3 drops of the treated sample extract (60μl-80μl) ver�cally into the sample well of the test casse�e. 3. The results are observed a�er 15 minutes and showed no clinical significance a�er 20 minutes.

Interpreta�on of Result POSITIVE: Two dis�nct red lines appear. One line should be in the control region (C) and the other line should be in the test region (T). NEGATIVE: One red line appears in the control region(C). No red line appears in the test region (T). The nega�ve result does not indicate the absence of analytes in the sample, it only indicates the level of tested analytes in the sample is less than cut-off level. INVALID: No colored lines appear or control line fails to appear, indica�ng that the operator error or reagent failure. Verify the test procedure and repeat the test with a new tes�ng device. Limita�on 1. The result of the product should not be taken as a confirmed diagnosis, for clinical reference only. Judgement should be made along with RT-PCR results, clinical symptoms, epidemic condi�on and further clinical data. 2. In the early stage of infec�on, the test result may be nega�ve because the low SARS-CoV-2 an�gen level or an�gen has not yet appeared in the sample. 3. Due to the limita�on of the detec�on method, the nega�ve result cannot exclude the possibility of infec�on. The posi�ve result should not be taken as a confirmed diagnosis. Judgement should be made along with clinical symptoms and further diagnosis methods. 4. This reagent can only qualita�vely detect SARS-CoV-2 an�gens in human nasopharyngeal swab, oropharyngeal swab. It cannot determine the certain an�gen content in the samples. 5. The accuracy of the test depends on the sample collec�on process. Improper sample collec�on, improper sample transporta�on and storage or freezing and thawing of the sample will affect the test results. 6. It is op�mum when elu�ng swabs with the matched samples extrac�on solu�on. Using other diluents may result in wrong results. 7. The solu�on and test card must be equilibrated to room temperature (20℃~30℃) before used, otherwise the results may be incorrect. 8. Sensi�vity maybe decrease if the sample did not test directly. Please test the sample as soon as possible. 9. Cross reac�ons maybe exist due to the N protein in SARS has a high homology with the new coronavirus (SARS-CoV-2). However, the interpreta�on of the results is not affected during seasons without SARS infec�on. 10. Analysis the possibility of false nega�ve results: 1) Inappropriate sample collec�on, using other non-matching solu�on, sample transfer �me is too long (more than half an hour), the volume of solu�on added when eluted the swab are too much, non- standardized elu�on opera�on, low virus �ter in the sample, these may all lead to false nega�ve results. 2) Muta�ons in viral genes may lead to changes in an�gen epitope, leading to false nega�ve results.

Posi�ve Nega�ve Invalid

C

T

11. Analysis the possibility of false posi�ve results: 1) Inappropriate sample collec�on, using other non-matching solu�ons, non- standardized elu�on opera�on, these may all lead to false posi�ve results. 2) Cross-contamina�on of samples may lead to false posi�ve results. 3) False nega�ve result from nucleic acid. 12. Analysis the possibility of invalid result: 1) If the sample volume is not enough, the chromatography cannot be carried out successfully. 2) The test card would invalid if the package was broken. The packaging status must be carefully checked before use. 13. In different stages of infec�on，samples of different viral load may have different coincidence rates with nucleic acid test results. 14. When sampling a nasopharyngeal swab, both nostrils need to be sampled with the same swab. If you only take it once, it may cause wrong results. Performance Characteris�cs 1. Posi�ve coincidence rate Test with posi�ve references, the results should be posi�ve. 2. Nega�ve coincidence rate Test with nega�ve references, the results should be nega�ve. 3.Limit of detec�on Test with the limit of detec�on reference, the result should be posi�ve. 4. Repeatability The repeatable reference is tested in parallel for 10 �mes, and the test results should be all posi�ve with uniform color. 5. Cross-reac�vity The results showed no cross reac�vity with influenza a virus, influenza B virus, respiratory adenovirus, respiratory syncy�al virus and mycoplasma pneumoniae. 6. Interfering The test result of SARS-CoV-2 An�gen Rapid Test do not be interfered with the following drugs ： zanamivir, ribavirin, oseltamivir, levofloxacin cefradine meropenem, tobramycin, oxymetazoline hydrochloride nasal spray, budesonide. Precau�on 1. The reagent is a disposable diagnos�c reagent in vitro, which is only used for the detec�on of human nasopharyngeal swab, or oropharyngeal swab. The opera�on should be carried out strictly according to the instruc�ons. Do not use expired and damaged products. 2. The strength of the quality control line does not mean the quality of the reagent, as long as its color is clear and visible, that means the reagent is effec�ve. 3. The kit should be sealed and kept away from moisture. Reagents or samples stored at low temperature should be balanced to room temperature before they can be used. 4. Reagents should be used as soon as possible a�er removal from aluminum foil bags, so as to avoid exposure to air for too long and affec�ng test results due to dampness. 5. Do not use samples that have been placed for too long or contaminated. 6. Please operate in accordance with the laboratory tes�ng procedures for infec�ous diseases. Waste a�er use should be treated in accordance with infec�ous substances and should not be discarded at will. 7. Incorrect opera�on may affect the accuracy of the results, such as insufficient sample mixing, insufficient amount, inaccurate detec�on �me, etc.

8. Components in different batch should not be mixed. 9. There should be appropriate biosafety assurance procedures for those substances containing and suspected sources of infec�on. The following are relevant considera�ons: 1) Handle samples and reagents with gloves; 2) Do not suck samples with your mouth; 3) Do not smoke, eat, drink, cosme�c or handle contact lenses while handling these items; 4) Disinfect the spilled sample or reagent with disinfectant; 5) Disinfect and treat all samples, reagents and poten�al pollutants in accordance with relevant local regula�ons; 6) Each component of the reagent remains stable un�l the expiry date under proper handling and storage condi�ons. Do not use the expired reagent kit. MANUFACTURER / POST-SALE SERVICE UNIT Qingdao Hightop Biotech Co., Ltd. Add.: No.369 Hedong Road, Hi-tech Industrial Development Zone, Qingdao, Shandong,266112, China Tel: 0086-532-58710705 Fax: 0086-532-58710706 Web: www.hightopbio.com E-mail: sales@hightopbio.com EUROPEAN REPRESENTATIVE MedNet EC-REP GmbH Borkstrasse 10, 48163 Muenster, Germany

INSTRUCTIONS OF SYMBOL

Consult instruc�ons for use

Keep dry

Temperature limit

Batch code

For single use

In vitro diagnos�c

medical device

Manufacturer

Date of manufacture

Use-by date

Contains sufficient for <n> tests

Keep away from sunlight

European representa�ve

IFU SARS-CoV-2 An�gen A/1

DECLARATION OF CONFORMITY

EUROPEAN REPRESENTATIVE

MedNet EC-REP GmbH

Borkstrasse 10 · 48163 Muenster · Germany

MANUFACTURER Qingdao Hightop Biotech Co., Ltd. No.369 Hedong Road, Hi-tech Industrial Development Zone, Qingdao, Shandong, 266112, China

PRODUCT SARS-CoV-2 Antigen Rapid Test (Immunochromatography)

--- Analyte：SARS-CoV-2 Antigen

CLASSIFICATION Others

CONFORMITY ASSESSMENT ROUTE IVDD 98/79/EC Annex III (Excluding 6)

EC Declaration of Conformity

DOC-SARS-CoV-2 Antigen A/0

WE, THE MANUFACTURER, IS EXCLUSIVELY RESPONSIBLE FOR THE DECLARATION OF

CONFORMITY. WE HEREWITH DECLARE THAT THE ABOVE MENTIONED PRODUCTS MEET

THE PROVISIONS OF THE COUNCIL DIRECTIVE 98/79/EC. ALL SUPPORTING DOCUMENTATION IS RETAINED UNDER THE PREMISES OF THE MANUFACTURER.

STANDARDS APPLIED 98/79/EC, EN ISO 18113-1:2011, EN ISO 18113-2:2011, EN 13612: 2002, EN ISO 23640:2015, EN 13641: 2002, EN ISO 15223-1: 2016, EN 13975:2003, EN ISO 14971:2012, EN ISO 13485: 2016, EN ISO 17511: 2003, EN 62366-1:2015.

PLACE, DATE OF ISSUE Qingdao，2020-6-12

Mr. Frank Yang

General Manager

SIGNATURE