ACON SARS-CoV-2 User manual

Swiss Point of Car

SARS-CoV-2 Antigen Rapid Test

Package Insert

A rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens.

For professional in vitro diagnostic use only.

The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results, from patients with symptom beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-

19. The SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. SARS-CoV-2 Antigen Rapid Test is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.

The novel coronaviruses belong to the β genus.1 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. 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.

The SARS-CoV-2 Antigen Rapid Test is a qualitative membrane based chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab specimens. When specimens are processed and added to the test cassette, SARS-CoV-2 antigens, if present in the specimen, will react with the anti-SARS-CoV-2 antibody-coated particles, which have been pre-coated on the test strip.

The mixture then migrates upward on the membrane by capillary action. The antigen-conjugate

complexes migrate across the test strip to the reaction area and are captured by a line of antibody bound on the membrane. Test results are interpreted visually at 15-30 minutes based on the presence or absence of visually

colored lines.

To serve as a procedure control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

The test cassette contains anti-SARS-CoV-2 antibodies. The positive control swab contains SARS-CoV-2 recombinant antigen pre-coated on the swab.

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

biological hazards throughout testing and follow the standard procedures for proper disposal of specimens.

 Wear protective clothing such as laboratory coats, disposable gloves, mask and eye protection when

specimens are being tested.

 The used test should be discarded according to local regulations. The used test should be considered

potentially infectious and be discarded according to local regulations.

 Humidity and temperature can adversely affect results.

REF L031-11823A English

INTENDED USE

SUMMARY

PRINCIPLE

REAGENTS

PRECAUTIONS

 This package insert must be read completely before performing the test. Failure to follow directions in insert

may yield inaccurate test results.

 The test line for a high viral load sample may become visible within 15 minutes, or as soon as the sample

passes the test line region.

 The test line for a low viral load sample may become visible within 30 minutes.

STORAGE AND STABILITY

 The kit can be stored at temperatures between 2 - 30 °C.  The test is stable until the expiration date printed on the sealed pouch.  The test must remain in the sealed pouch until use.  DO NOT FREEZE.  Do not use after the expiration date.

MATERIALS

Materials Provided

 Test Cassettes  Extraction Tubes  Positive Control Swab  Negative Control Swab  Disposable Swabs*  Extraction Buffer  Package Insert

* The Disposable Swabs are produced by another manufacturer.

Materials Required But Not Provided

 Personal Protective Equipment  Timer

SPECIMEN COLLECTION AND PREPARATION

 The SARS-CoV-2 Antigen Rapid Test can be performed using nasal swab specimens.  Testing should be performed immediately after specimen collection, or at most within one (1) hour after

specimen collection, if stored at room temperature (15-30°C).

 To collect a nasal swab sample:

1. Carefully insert a Disposable Swab, provided with your kit, into one

nostril. Using gentle rotation, push the swab up to 2.5 cm (1 inch) from

the edge of the nostril.

2. Rotate the swab 5 times against the mucosa inside the nostril to ensure

sufficient specimen collection.

3. Using the same swab, repeat this process in the other nostril to ensure

that an adequate amount of sample is collected from both nasal cavities.

4. Withdraw the swab from the nasal cavity. The specimen is now ready for preparation using the

extraction buffer tubes.

DIRECTIONS FOR USE

Allow the test and extraction buffer to reach room temperature (15-30 °C) prior to testing.

1. Use an extraction buffer tube for each specimen to be tested and label each tube appropriately.

2. Hold the extraction buffer bottle upside down vertically, then add approximately 300 μL (10~12 drops) of extraction buffer to the extraction tube.

3. Insert the swab into the tube and swirl it for 30 seconds. Then rotate the swab at least 5 times while squeezing the sides of the tube. Take care to avoid splashing contents out of the tube.

4. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.

5. Attach the dropper tip firmly onto the extraction buffer tube containing the sample. Mix thoroughly by swirling or flicking the bottom of the tube.

6. Remove the test cassette from the foil pouch and use it as soon as possible.

7. Place the test cassette on a flat and clean surface.

8. Add the processed specimen to the sample well of the test cassette.

a. Invert the extraction buffer tube with the dropper tip pointing downwards and hold it vertically.

b. Gently squeeze the tube, dispensing 4 drops of the processed specimen into the sample well.

9. Wait for the colored line(s) to appear. The result should be read at 15-30 minutes. Do not read the

result after 30 minutes.

Rotate at least 5 times while squeezing the tube

4 drops of the

processed

specimen

Swirl for 30 seconds

15-30 min.

Negative Positive Invalid

INTERPRETATION OF RESULTS

NEGATIVE: Only one colored control line appears in the control region (C).

in the test line region (T). This means that no SARS-CoV-2 antigen was detected. POSITIVE:* Two distinct colored lines appear. One line in the control line region (C) and the other line in the test line region (T). This means that the presence of SARS-CoV-2 antigen was detected. *NOTE: The intensity of the color in the test line (T) may vary depending on the level of the SARS-CoV-2 antigen present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive. INVALID: Control line fails to appear. Insufficient specimen volume or incorrect operation are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

(Please refer to the illustration above)

No apparent colored line appears

QUALITY CONTROL

Internal procedural controls are included in the test. A colored line appearing in the control line region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Positive and Negative control swabs are supplied with each kit. These control swabs should be used to ensure that the test cassette and that the test procedure is performed correctly. Follow the “DIRECTIONS FOR USE” section to perform the control test. The control swabs can be tested under any of the following circumstances:

1. When new lot of tests are used and/or when a new operator performs the test.

2. At periodic intervals as dictated by local requirements, and/or by the user’s Quality Control procedures.

LIMITATIONS

1. The SARS-CoV-2 Antigen Rapid Test is for in vitro diagnostic use only. The test should be used for the detection of SARS-CoV-2 antigens in nasal swab specimens only. The intensity of the test line does not necessarily correlate to SARS-CoV-2 viral titer in the specimen.

2. Specimens should be tested as quickly as possible after specimen collection and at most within the hour following collection.

3. Use of viral transport media may result in decreased test sensitivity.

4. A false-negative test may result if the level of antigen in a sample is below the detection limit of the test or if the sample was collected incorrectly.

5. Test results should be correlated with other clinical data available to the physician.

6. A positive test result does not rule out co-infections with other pathogens.

7. A positive test result does not differentiate between SARS-CoV and SARS-CoV-2.

8. A negative test result is not intended to rule out other viral or bacterial infections.

9. A negative result, from a patient with symptom onset beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for clinical management.

(If the differentiation of specific SARS viruses and strains is needed, additional testing is required.)

PERFORMANCE CHARACTERISTICS

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The performance of SARS-CoV-2 Antigen Rapid Test was established with 577 nasal swabs collected from individual symptomatic patients who were suspected of COVID-19. The results show that the relative sensitivity and the relative specificity are as follows:

SARS-CoV-2 Antigen

Rapid Test

Relative Sensitivity: 96.9% (92.8%-98.9%)* Relative Specificity: 99.5% (98.1%-99.9%)* Accuracy: 98.8% (97.5%-99.5%)* *95% Confidence Intervals

Stratification of the positive samples post onset of symptoms between 0-3 days has a positive percent agreement (PPA) of 98.7% (n=75) and 4-7 days has a PPA of 96.7% (n=60).

Positive samples with Ct value ≤33 has a higher positive percent agreement (PPA) of 98.7% (n=150) .

The LOD of SARS-CoV-2 Antigen Rapid Test was established using limiting dilutions of a viral sample inactivated by gamma irradiation. The viral sample was spiked with negative human nasal sample pool into a seral of concentrations. Each level was tested for 30 replicates. The results show that the LOD is 1.6*10

/mL.

TCID

Sample SARS-CoV-2 Concentration % Positive (Tests)

1.28*103 TCID50/mL 100% (30/30)

6.4*102 TCID50/mL 100% (30/30)

3.2*102 TCID50/mL 100% (30/30)

1.6*102 TCID50/mL 96.7% (29/30) 8*10 TCID50/mL 0% (0/30)

Clinical Sensitivity, Specificity and Accuracy

Clinical Performance for SARS-CoV-2 Antigen Rapid Test

Method RT-PCR

Results Negative Positive

Negative 413 5 418

Positive 2 157 159

Total Results 415 162 577

Limit of Detection (LOD)

Total

Results

Cross-Reactivity (Analytical Specificity) and Microbial Interference

Cross-reactivity was evaluated by testing a panel of related pathogens and microorganisms that are likely to be present in the nasal cavity. Each organism and virus were tested in the absence or presence of heatinactivated SARS-CoV-2 virus at low positive level.

No cross-reactivity or interference was observed with the following microorganisms when tested at the concentration presented in the table below. The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.

Potential Cross-Reactant Test Concentration

Adenovirus 1.14 x 106 TCID50/mL

Enterovirus 9.50 x 105 TCID50/mL

Human coronavirus

229E

Human coronavirus

OC43

Human coronavirus

NL63

Human

neumovirus

Meta

MERS-coronavirus 7.90 x 105 TCID50/mL

Influenza A 1.04 x 105 TCID50/mL

Virus

Influenza B 1.04 x 105 TCID50/mL

Parainfluenza virus 1 1.25 x 105 TCID50/mL

Parainfluenza virus 2 3.78 x 105 TCID50/mL

Parainfluenza virus 3 1.0 x 105 TCID50/mL

Parainfluenza virus 4 2.88 x 106 TCID50/mL

Respiratory syncytial

virus

Rhinovirus 3.15 x 105 TCID50/mL

Human coronavirus-

HKU1

1.04 x 10

2.63 x 10

1.0 x 10

1.25 x 10

3.15 x 10

1 x 10

TCID50/mL

copies/mL

Cross-Reactivity

(in the absence of

SARS-CoV-2 virus

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

Interference

(in the presence of

SARS-CoV-2 virus

3/3 positive

Bordetella pertussis 2.83 x 109 CFU/mL

Chlamydia trachomatis 3.13 x 108 CFU/mL

Haemophilus influenza 1.36 x 108 CFU/mL

Legionella pneumophila 4.08 x 109 CFU/mL

Mycobacterium

tuberculosis

Mycoplasma

neumoniae

Staphylococcus aureus 1.38 x 107 CFU/mL

Bacteria

Staphylococcus

idermidis

Streptococcus

neumoniae

Streptococcus

Pneumocystis jirovecii-

Chlamydia pneumoniae 1×106 IFU/ml

Yeast Candida albicans 1.57 x 108 CFU/mL

The following substances, naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity or nasopharynx, were evaluated. Each substance was tested in the absence or presence of SARS-CoV-2 virus at low positive level. The final concentration of the substances tested are listed below and were found not to affect test performance.

Interfering

Substance

Endogenous

Afrin Original Nasal

ALKALOL Allerg

Relief Nasal Spra

Chloraseptic Max

Sore Throat

Lozenges

CVS Health Fluticasone

Propionate Nasal

Spray

Equate Fast-Acting

Nasal S

Equate Sore Throat

Phenol Oral

Anesthetic S

Original Extra

Strong Menthol

Cough Lozenges

NasalCrom Nasal

NeilMed NasoGel

for Dr

Throat Lozenge

Zicam Cold Remedy

Antibiotic Mupirocin 10 mg/mL 3/3 negative 3/3 positive

enes

S. cerevisiae

Pseudomonas

aeru

inosa

Pooled human nasal wash

Active Ingredient Concentration

Biotin 2.4 mg/mL 3/3 negative 3/3 positive

Mucin 0.5% w/v 3/3 negative 3/3 positive

Whole Blood 4% v/v 3/3 negative 3/3 positive

Oxymetazoline 15% v/v 3/3 negative 3/3 positive

Homeopathic 1:10 Dilution 3/3 negative 3/3 positive

Menthol,

Benzocaine

Fluticasone

propionate

Phenylephrine 15% v/v 3/3 negative 3/3 positive

Phenol 15% v/v 3/3 negative 3/3 positive

Menthol 1.5 mg/mL 3/3 negative 3/3 positive

Cromolyn 15% v/v 3/3 negative 3/3 positive

Noses

Sodium

Hyaluronate

Dyclonine

drochloride

Galphimia glauca,

Luffa operculata,

Sabadilla

1.72 x 10

CFU/mL

7.90 x 10

CFU/mL

2.32 x 10

CFU/mL

1.04 x 10

4.10 x 10

CFU/mL

8.63 x 10

CFU/mL

1.87 x 10

Interfering Substances

1.5 mg/mL 3/3 negative 3/3 positive

5% v/v 3/3 negative 3/3 positive

1.5mg/mL 3/3 negative 3/3 positive

5% v/v 3/3 negative 3/3 positive

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

3/3 ne

ative

Results

(in the absence of

SARS-CoV-2 virus)

3/3 positive

(in the presence of

SARS-CoV-2 virus)

Results

Tam i fl u

Antibiotic Tobramycin 4 µg/mL 3/3 negative 3/3 positive

Mometasone

Furoate Nasal

Spray

Physiological

Seawater Nasal

Cleaner

Oseltamivir Phos

hate

Mometasone

Furoate

NaCl 15%v/v 3/3 negative 3/3 positive

5 mg/mL 3/3 negative 3/3 positive

5%v/v 3/3 negative 3/3 positive

PRECISION

Within-run precision was determined using 10 replicates of specimens: negative control and SARS-CoV-2 antigen positive controls. The specimens were correctly identified >99% of the time.

Between-run precision was determined using 10 independent assays on the same specimen: negative specimen and SARS-CoV-2 an tigen positive specimen. Three different lots of the SARS-CoV-2 Antigen Rapid Test were tested using these specimens. The specimens were correctly identified >99% of the time.

Intra-Assay

Inter-Assay

BIBLIOGRAPHY

1. Shuo Su, Gary Wong, Weifeng Shi, et al. Epidemiology, Genetic recombination, and pathogenesis of coronaviruses. Trends in Microbiology, June 2016, vol. 24, No. 6: 490-502

2. Susan R. Weiss, Julian L. Leibowitz, Coronavirus Pathogenesis, Advances in Virus Research, Volume 81: 85-164

Manufacturer

In vitro diagnostic

IVD

medical device

Consult instructions for use

Index of Contents

Authorized representative in the European Community

SARS-CoV-2 Antigen

Negative Control Swab

Positive Control Swab

Extraction Tubes

Extraction Buffer

Disposable Swabs

SARS-CoV-2 Antigen Rapid Test

Index of Symbols

LOT

Contains sufficient for <n> tests

Use-by date

Batch code

REF

SARS-CoV-2 Antigen

Negative Control Swab

Positive Control Swab

Extraction Tubes

Extraction Buffer

Disposable Swabs

SARS-CoV-2 Antigen Rapid Test

Temperature limit

Do not reuse

Catalogue number

Date of manufacture

Biotech (Hangzhou) Co., Ltd.

No.210 Zhenzhong Road, West Lake District, Hangzhou, P.R.China, 310030

Distributor:

MedNet GmbH Borkstrasse 10

48163 Muenster, Germany

www.swisspointofcare.com

Number: 1151255102

Effective date: 2020-xx-xx

ACON SARS-CoV-2 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual