Antigen Test (MAYLAB)

SARS - COVID-19 Antigen Rapid Test Cassette

Prospectus

Rapid test for the qualified detection of Covid-19 antigen in swab or aspiration specimens. For use only by professionals in in vitro diagnostics.

Intended Use

The Sars-Covid-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Covid-19 antigen in swab or respiratory specimens. Identification is based on monoclonal antibodies specific for the Nucleocapsid (N) protein of SARS-CoV-2 virus. It is intended to aid in the rapid differential diagnosis of Covid-19 infections.

SUMMARY

The new coronaviruses belong to the ß gene. Covid-19 is an acute infectious respiratory disease. People are usually susceptible to this disease. Currently, coronavirus-infected patients are the main source of infection; asymptomatic infected persons may also be a source of infection. Based on the current epidemiological review, the incubation period is between 1 and 14 days, mostly between 3 and 7 days. The main indicators include fever, malaise and dry cough. In a few cases, nasal congestion, runny nose, sore throat, myalgia and diarrhoea have also been found.

The Sars-Covid-19 Antigen Rapid Test Cassette (Swab/Inspiration) provides results within 10 minutes by detecting Covid-19 antigen in swab and respiratory specimens together. The test utilises Covid-19 coronavirus-specific antibodies in swab or respiratory specimens.

PRINCIPLE

The Sars-Covid-19 Antigen Rapid Test Cassette (Swab/Inspiration) is a qualitative and lateral immunoassay for the detection of the N protein of SARS-CoV-2 virus in swab and respiratory specimens. In this test, antibodies specific for the N protein of SARS-Cov-2 virus are separately coated on the test line sections of the test cassette. During the test, the specimens react to antibodies to the N protein of the SARS-CoV-2 virus coated on the particles. This mixture is transported across the membrane to react with the antibody to the N protein of the SARS-CoV-2 virus on the membrane and forms a single coloured line at the test sites. The presence of this coloured line in the test regions indicates a positive result. To serve as a methodological control, if the test has worked correctly, a coloured line always appears in the control region.

SYMPTOMS

This test cassette contains anti-coronavirus 2019-nCoV Nucleocapsid protein particles and anti-coronavirus 2019-CoV Nucleocapsid protein coated on membrane.

PRECAUTIONS

Please read all the information in this leaflet before performing the test.

1. For use only by professionals in in-vitro diagnostics. Do not use after the expiry date.
2. The test must remain in the sealed package until ready for use.
3. All samples should be considered potentially dangerous and should be handled in the same way as an infectious agent.
4. The used test must be disposed of according to local regulations.
5. Avoid using specimens with blood.
6. Wear gloves when handling specimens and avoid touching the reagent membrane and specimen well.

STORAGE and DURABILITY 

Store packaged at room temperature or refrigerated (2-30℃). The test will last until the expiry date printed on the sealed package. The test must remain in the sealed package until used. DO NOT freeze. Do not use after the expiry date.


SAMPLE TAKING and PREPARATION

Nasal Swab Sample Insert a sterile swab fully into the nasal cavity through one of the nostrils and collect the muco-epidermis by rubbing it several times against the nasal bone.   

Throat swab sample Insert a sterile swab into the larynx and collect mucoepidermis by rubbing the swab several times, mostly on the quivering part of the posterior wall of the larynx and the tonsils. Be careful not to get saliva on the swab.

lAspiration Specimen Dip a sterile swab into the specimen and allow the specimen to adhere to the swab.

MATERIALS

• Materials Provided
• Test Cassettes Tube Containing Extraction Reagent Sterile Swabs
• Prospectus
• Materials required but not provided
• Timer

INSTRUCTIONS FOR USE

Allow the test, extraction buffer to come to room temperature (15-30°) before performing the test.

1. Remove the test cassette from the sealed aluminium package and use within one hour. Best results are obtained if the evaluation is performed immediately after opening the aluminium package.
2. Place the swab specimen into the extraction tube. Rotate the swab for approximately 10 seconds while pressing the head into the tube to release the antigen from the swab. Refer to Figure1.
3. Remove the swab while squeezing it against the inside of the Extraction Tube as you remove it to expel as much fluid as possible from the swab. Dispose of the swab in accordance with your biohazard waste disposal protocol. Refer to Figure 2.
4. Place the dropper tip on top of the extraction tube. Place the test cassette on a clean, level surface. Refer to Figure 3.
5. Add 3 drops of solution (approximately 80μL) to the sample well and then start the timer. Refer to Figure 4.

After 10 minutes, read the results. After 20 minutes, do not interpret the result.

INTERPRETATION OF RESULTS (Please Refer to Specified Figures)

POSITIVE: * Two coloured lines appear. One of the coloured lines should be in the control line ( C ) section and the other in the test line ( T ) section. A positive result indicates that COVID-19 has been detected in the sample.

* NOTE: The intensity of the colour in the test line ( T ) section varies depending on the concentration of Covid-19 antigen in the specimen. Therefore, any colour in the test line ( t ) region should be considered positive.

NEGATIVE: A single coloured line appears in the control line ( C ) section. No line appears in the test line ( T ) region. A negative result indicates that the sample contains no Covid-19 antigen or less than the test can measure.

INVALID: The control line does not appear. Insufficient sample quantity or incorrect procedural techniques are the most likely reasons for the control line not appearing. Review the procedure and repeat the test using a new test. If the problem persists, discontinue use of the test immediately and contact your local distributor.

QUALITY CONTROL

A methodological check is included in the A Test. The appearance of a coloured line in the control line ( C ) region is considered an internal methodical check. It verifies adequate membrane absorption.

Control standards are not included with this kit, but it is recommended that positive and negative controls be tested as a good laboratory practice to verify the test procedure and proper test performance.

RESTRICTIONS

1. The Sars-Covid-19 Antigen Rapid Test Cassette (Swab/Aspiration) is for use by professionals in in-vitro diagnostics only. This test should be used to detect Covid-19 Antigen in swab or aspirate specimens. The numerical value or the rate of increase in the density of SARS-CoV-2 virus cannot be determined by this proficiency test.
2. The accuracy of the test depends on the quality of the swab sample. False negatives may result from incorrect sample collection or improper storage of the test.
3. The Sars-Covid-19 Antigen Rapid Test Cassette (Swab/Aspiration) only indicates the presence of both viable and non-viable SARS-CoV-2 coronavirus chains in the specimen.
4. As with all diagnostic tests, all results must be considered in conjunction with other clinical information available to the doctor.
5. A negative result from this test must be confirmed by PCR. A negative result may be obtained if the concentration of SARS-CoV-2 virus in the sample is insufficient or below the level that the test can detect.
6. Excessive amounts of blood or mucus in the swab sample may affect the test performance and produce a false positive result.
7. A positive result for Covid-19 does not indicate a concomitant infection with another pathogen. Therefore, the possibility of another underlying bacterial infection should be considered.
8. Negative results do not rule out SARS-CoV-2 infection, especially contact with the virus. A follow-up molecular diagnostic test should be considered to rule out infection in these individuals.
9. Positive results may be due to an infection caused by non-SARS-CoV-2 coronavirus chains such as HKU1, NL63, OC43 or 229E coronaviruses.
10. The results of the antigen test should not be used as the sole basis for diagnosing SARS-CoV-2 infection or absence, or for determining infection status.

PERFORMANCE SPECIFICATIONS

Precision, Accuracy and Correctness

Sars-Covid-19 Antigen Rapid Test Cassette (Swab/Aspiration) specimens obtained from patients were evaluated. RT-PCR was used as the reference method for the Sars-Covid-19 Antigen Rapid Test Cassette (Swab/Aspiration). Samples were considered positive if PCR gave a positive result. 

Relative Sensitivity: 95.0% (95%CI*:83.1%-99.4%)*

Relative Certainty: 99.2% (95%CI*:97.6%-99.8%)*

Relative Accuracy: 98.8% (95%CI*:97.1%-99.6%)* *

* Reliability Range

DETECTION LIMIT

The limit of detection for the Sars-Covid-19 Antigen Rapid Test Cassette (Swab/Aspiration) was determined by limiting reconstitution of an inactivated virus sample.  The material (ZeptoMetriz, 0810587CFHI) was provided at a density of 1.15 x 107.2 TCID 50/mL. The estimated limit of detection is 4.0 x 103TCID 50/mL.

CROSS REACTIVITY

Sars-Covid-19 Antigen Rapid Test Cassette (Swab/Inspiration) Influenza A virus, Influenza B virus, Adeno virus, Coxsackie virus, Parainfluenza virus Type 4a, Enterovirus, Mumps virus, Respiratory syncytial virus, Rhinovirus, Bordetellapertussis, Haemophilusparainfluenzae, Staphylococcusaureus, Streptococcusagalactiae, Neisseriameningitides, Streptococcus sp. Group A, Streptococcus sp. Group B, Streptococcus sp. Group C and Candidaalbicans. The results showed no cross-reactivity.

SOURCE

1. WeissSR, LeibowitzJL. Coronaviruspathogenesis. AdvVirusRes 2011;81:85-164.
2. Cui J, Li F, ShiZL. Originandevolution of pathogeniccoronaviruses. NatRevMicrobiol 2019; 17:181-192.
3. Su S, Wong G, Shi W, et al. Epidemiology, geneticrecombination, andpathogenesis of coronaviruses. TrendsMicrobiol 2016;24:490-502.