Rapid COVID-19 Antigen Test Kit

SARS-CoV-2 Antigen Rapid Test
(Saliva / Nasopharyngeal Swab)

A rapid test for the qualitative detection of Novel Coronavirus SARS-CoV-2 antigen in Saliva and/or Nasopharyngeal swab.

Dependable accurate results 

  • Sensitivity: 95.8%
  • Specificity: 99.2%
  • LOD: 1000 TCID50 /ml 

Unmatched convenience 

  • Individual buffer vials Helping multiple operators at same time 
  • Visual results
    Easy to interpre
    t 
  • Fast. Only 10 minutes test time
SKU: COV19-TEST-KITS Category:
Description

Description

Visual SARS-CoV-2 Antigen Test

Your Winning Partner in the Fight against COVID-19


Dependable accurate results

  • Sensitivity: 95.8%
  • Specificity: 99.2%
  • LOD: 1000 TCID50 /ml

Unmatched convenience

  • Individual buffer vials Helping multiple operators at same time
  • Visual results
    Easy to interpre
    t
  • Fast. Only 10 minutes test time

 

SARS-CoV-2 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab)

Instruction for use

A rapid test for the qualitative detection of Novel Coronavirus SARS-CoV-2 antigen in Saliva and/or Nasopharyngeal swab.

For professional in vitro diagnostic use only Store at 2°C – 30°C (36oF – 86oF)

 

CONTENT

  1. Intended Use……………………………………………………………………………………………………………. 1
  2. Principle…………………………………………………………………………………………………………………. 1
  3. Reagents…………………………………………………………………………………………………………………. 1
  4. Precautions……………………………………………………………………………………………………………… 2
  5. Storage And Stability………………………………………………………………………………………………….. 2
  6. Specimen Collection And Preparation……………………………………………………………………………… 3
  7. Materials………………………………………………………………………………………………………………… 4
  8. Directions For Use……………………………………………………………………………………………………… 5
  9. Interpretation Of The Results……………………………………………………………………………………….. 7
  10. Quality Control……………………………………………………………………………………………………….. 7
  11. Limitations…………………………………………………………………………………………………………….. 8
  12. Performance Characteristics……………………………………………………………………………………….. 9
  13. Explanation Of The Symbols Used……………………………………………………………………………….. 13
  14. References…………………………………………………………………………………………………………… 14
  15. Date Of Issue………………………………………………………………………………………………………… 14
  16. General Information……………………………………………………………………………………………….. 14

 

1. INTENDED USE

The SARS-CoV-2 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in Saliva and Nasopharyngeal swab. The identification is based on the monoclonal antibodies specific for the Nucleocapsid (N) protein of SARS-CoV-2. It is intended to aid in the rapid diagnosis of COVID-19 infections.

1.1. Abbreviations

SARS-CoV-2: novel coronavirus

COVID-19: novel coronavirus pneumonia

1.2. Summary

The new coronavirus belongs to the coronavirus of the genus β. It has an envelope and the particles are round or elliptical. They are often polymorphic and have a diameter of 60-140 nm. Its genetic characteristics are significantly different from SARS-CoV and MERS-CoV. Current research shows that the homology with bat SARS-like corona virus (bat-SL-CoVZC45) is more than 85%. When isolated and cultured in vitro, the new coronavirus can be found in human respiratory epithelial cells in about 96 hours, while it takes about 6 days to separate and culture in VeroE6 and Huh-7 cell lines.

The new coronavirus (SARS-COV-2) antigen detection method can effectively reduce the false negatives of RT- PCR and false positives of antibody detection methods. The diagnosis is fast, accurate and requires low equipment and personnel, suitable for rapid investigation of suspected cases of novel coronavirus infection on a large scale. The rapid investigation of suspected cases is effective during outbreaks and also can be used as a supplementary test for nucleic acid testing to avoid the risk of new transmission caused by the discharge of false negative patients.

2. PRINCIPLE

The SARS-CoV-2 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) is a qualitative, lateral flow immunoassay for the detection of the N protein of SARS-CoV-2 in saliva and Nasopharyngeal swab. In this test, antibody specific to the N protein of SARS-CoV-2 is separately coated on the test line regions of the test cassette. During testing, the extracted specimen reacts with the antibody to N protein of SARS-CoV-2 that are coated onto particles. The mixture migrates up the membrane to react with the antibody to N protein of SARS-CoV-2 on the membrane and generate one colored line in the test regions. The presence of this colored line of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.

3. REAGENTS

The test cassette contains anti-SARS-CoV-2 Nucleocapsid protein particles and anti-SARS-CoV-2 Nucleocapsid protein coated on the membrane.

 

4. PRECAUTIONS

  1. For professional in vitro diagnostic use
  2. Follow the instructions for use carefully. Reliability of assay results cannot be guaranteed if there is any deviation from the instructions in this instruction for
  3. The test should remain in the sealed pouch until ready to
  4. All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
  5. Avoid using bloody samples.
  6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection before
  7. The used tests, specimens and potentially contaminated material should be discarded according to the local regulations.
  8. Humidity and temperature can adversely affect
  9. Do not store this kit in frozen
  10. Do not use the product if package is
  11. Do not use the product after expiration
  12. Do not re-use the
  13. Use only the extraction solution provided with the
  14. Read and interpret the results at 10 minutes, do not interpret the results after 20
  15. Do not eat, drink or smoke in the area where the specimens or kits are

5. STORAGE AND STABILITY

Store as packaged at room temperature or refrigerated 2°C – 30°C (36°F – 86°F). 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.

 

6. SPECIMEN COLLECTION AND PREPARATION

The SARS-CoV-2 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab) can be performed using Saliva and Nasopharyngeal Swab specimens. The quality of specimens obtained is of extreme importance. Detection of SARS- COV-2 Antigen requires a vigorous and thorough collection technique that provides SARS-CoV-2 Antigen rather than just body fluids.

To collect Saliva Specimen:

Use the collection tube to collect saliva. Open the cap of the collection tube. Install saliva collector, put the collection tube with saliva collector close to lips and let the saliva flow into the collection tube. The volume of saliva needs to be between two scale marks (approx. 150-300 μl). If the volume of saliva is too much, use a dropper to remove the excess saliva until the final solution is between the two scale marks (approx. 150-300 μl).

To collect Nasopharyngeal swab Specimen:

Insert swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the swab is saturated with fluid from the first collection. If a deviated septum or blockage create difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.

Please use as soon as possible after taking samples.

 

7.             MATERIALS

7.1.     Material Provided

COV19-TEST-KITS
Item number Content Quantity
1 Instruction for use 1 piece
2 Individually Pouched Test Cassettes 25 cassettes
3 Collection Tubes 25 tubes
4 Extraction Buffers (NaCl + Casein Sodium + Tris + Proclin 300) 25 tubes
5 Saliva Collectors 25 pieces
6 Sterile Swabs 25 pieces
7 Droppers 25 pieces
8 Workstation 1 piece

7.2. Materials required but not provided

  • Timer
  • Gloves

 

8. DIRECTIONS FOR USE

Allow the test cassette, specimen, extraction buffer to equilibrate to room temperature 15°C – 30°C (59°F – 86°F) prior to testing.

For Nasopharyngeal Swab Specimen:

  1. Remove the test Cassette from the sealed foil pouch and use it within one Best results will be obtained if the assay is performed immediately after opening the foil pouch.
  2. Place the collection tube in the workstation. Open the cap of the collection tube. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add all extraction buffer (Approx. 300μL) to the collection tube.
  3. Place the swab specimen in the collection tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the
  4. Remove the swab while squeezing the swab head against the inside of the extraction buffer as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your bio-hazard waste disposal
  5. Tighten cap on the specimen collection
  6. Place the test Cassette on a clean and level surface. Add 3 full drops (approx. 80µL) of the solution to the sample well and then start the Avoid trapping air bubbles in the sample well (S). Read the result at 10 minutes. Do not interpret the result after 20 minutes.Nasal Covid-19 Instructions

 

For Saliva Specimen:

  1. Remove the test Cassette from the sealed foil pouch and use it within one Best results will be obtained if the assay is performed immediately after opening the foil pouch.
  2. Open the cap of the collection tube. Install saliva collector, put the collection tube with saliva collector close to lips and let the saliva flow into the collection tub The volume of saliva needs to be between two scale marks (approx. 150-300 μl).
  3. Place the collection tube with saliva collector (containing the saliva specimen) in the workstation. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add all extraction buffer (Approx. 300μL) to the collection
  4. Discard the saliva collector, tighten the cap onto the specimen collection tube. Shake the specimen collection tube at least three times vigorously to mix the saliva and the extraction buffer, then squeeze bottom of the collection tube to ensure the saliva is thoroughly
  5. Place the test Cassette on a clean and level surface. Add 3 full drops (approx. 80µL) of the solution to the sample well (S) and then start the Avoid trapping air bubbles in the sample well (S). Read the result at 10 minutes. Do not interpret the result after 20 minutes.

9. INTERPRETATION OF THE RESULTS

9.1 NEGATIVE

One colored line appears in the control line region (C). No line appears in the test line region (T). A negative result indicates that SARS-CoV-2 antigen is not present in the specimen, or is present below the detectable level of the test.

 
9.2 POSITIVE:*

Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). A positive result indicates that SARS-CoV-2 antigen was detected in the specimen.

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of SARS-CoV-2 Antigen present in the specimen.

Therefore, any shade of color in the test line region

(T) should be considered positive.

 

9.3 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 the manufacturer or your supplier.

 

10. QUALITY CONTROL

A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms adequate membrane wicking.

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

 

11. LIMITATIONS

  1. This device is for professional in vitro diagnostic use
  2. This device is only used for testing human saliva and/or nasopharyngeal swab
  3. Neither the quantitative value nor the rate of increase in SAR-CoV-2 virus concentration can be determined by this qualitative
  4. The accuracy of the test depends on the quality of the swab sample. False negatives may result from improper sample collection or
  5. The SARS-CoV-2 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) will only indicate the presence of SARS-CoV-2 in the specimen from both viable and non-viable SARS-CoV-2 coronavirus
  6. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the
  7. A negative result obtained from this kit should be confirmed by PCR. A negative result may be obtained if the concentration of the SARS-CoV-2 virus present in the swab is not adequate or is below the detectable level of the
  8. Excess blood or mucus on the saliva and/or swab specimen may interfere with test performance and may yield a false positive
  9. A positive result for SARS-CoV-2 does not preclude an underlying co-infection with another pathogen, therefore the possibility of an underlying bacterial infection should be
  10. 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.
  11. Positive results may be due to present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or
  12. Results from antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection
  13. Extraction reagent has the ability to kill the virus, but it cannot inactivate 100% of the virus. The method of inactivating the virus can be referred to: what method is recommended by WHO/CDC, or it can be handled according to local

 

12. PERFORMANCE CHARACTERISTICS

12.1 Sensitivity, Specificity and Accuracy

The SARS-CoV-2 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab) has been evaluated with saliva and nasopharyngeal swab specimens obtained from the patients. RT-PCR is used as the reference method for the SARS- CoV-2 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab). Specimens were considered positive if PCR indicated a positive result.

Nasopharyngeal Swab Specimen

Method RT-PCR  

Total Results

 

SARS-CoV-2 Antigen Rapid Test Cassette

Results Positive Negative
Positive 140 5 145
Negative 6 440 446
Total Results 146 445 591

 

Relative Sensitivity: 95.9% (95% CI: 91.3% – 98.1%)
Relative Specificity: 98.9% (95% CI: 97.4% – 99.5%)
Relative Accuracy: 98.1% (95% CI: 96.7% – 99.0%)

*The Relative Sensitivity is 92.3% (95% CI: 87.3% – 95.5%) if samples with CT ≥ 33 are included.

 

Saliva Specimen

Method RT-PCR  

Total Results

 

SARS-CoV-2 Antigen Rapid Test Cassette

Results Positive Negative
Positive 19 0 19
Negative 1 162 163
Total Results 20 162 182

 

Relative Sensitivity: 95.0% (95%CI:75.1% – 99.9%)
Relative Specificity: >99.9% (95%CI:97.8% – 100.0%)
Relative Accuracy: 99.5% (95%CI:97.0% – 100.0%)

 

Saliva / Nasopharyngeal Swab Specimen

Method RT-PCR  

Total Results

 

SARS-CoV-2 Antigen Rapid Test Cassette

Results Positive Negative
Positive 159 5 164
Negative 7 602 609
Total Results 166 607 773

 

Relative Sensitivity: 95.8% (95% CI: 91.5% – 98.3%)
Relative Specificity: 99.2% (95% CI: 98.1% – 99.7%)
Relative Accuracy: 98.1% (95% CI: 97.3% – 99.2%)

 

12.2. Limit of Detection

The LOD for the SARS-CoV-2 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab) was established using serial dilutions of a viral sample inactivated. The material (ZeptoMetrix, 0810587CFHI) was supplied at a concentration of 1.15 x 107TCID50/mL. The Estimated LOD is 1000 TCID50/mL.

 

SARS-CoV-2 tested(TCID50/mL) Test Result
1.0×105TCID50/mL 15/15 Positive
3.0×103TCID50/mL 15/15 Positive
2.0×103TCID50/mL 15/15 Positive
1.5×103 TCID50/mL 15/15 Positive
1.0×103 TCID50/mL 15/15 Positive
7.5×102 TCID50/mL 15/15 Negative

 

 

12.3. Interfering Substances

The following potentially interfering substances were added to SARS-CoV-2 negative and spiked positive specimens. No substances showed any interference with the test.

 

Ambroxol Hydrochloride Tablets (7.5 mg/mL) Nasal antibiotic (Mupirocin Ointment)
Mometasone furoate nasal spray (0.05% g/g) Oxymetazoline Hydrochloride Spray
Herbal cough syrup Beclomethasone Dipropionate Nasal Aerosol
Dextromethorphan Hydrobromide Oral Solution (1.5 mg/ml) Triamcinolone Acetonide Nasal Spray
MucosolvanAmbroxol Hydrochloride Oral Solution Azelastine Hydrochloride Nasal Spray
Nasal cleansing solution, NaCl (5 g/L) Fluticasone Propionate Nasal Spray
Hyland’s 4 Kids Cold Cough Liquid Safe Natural Relief Physiological Seawater Nasal Spray
Durham’s Canker-Rid Tobramycin Eye Drops
Listerine mouthwash Whole blood (4%)
Scope mouthwash Mucin (0.05%)
Bilirubin(10mg/ml) Triglyceride(5mg/ml)
Hemoglobin(5mg/ml) HAMA

 

12.4. Cross Reactivity

The following potentially cross-reactive substances were added to SARS-CoV-2 negative and spiked positive specimens. The organisms or viruses do not cross-react.

List 1

 

Potential Cross-Reactant

 

Concentration

Results
Negative Specimen Spiked with Positive Specimen
Parainfluenza Virus Type4a 1.6×103 TCID50/ml Negative Positive
Human Coxsackievirus 2.8×105 TCID50/ml Negative Positive
Mumps virus 2.8×106 TCID50/ml Negative Positive
Rhinovirus 20 x 109 organisms/ml Negative Positive
Haemophilus parainfluenzae 6×106 bacteria/ml Negative Positive
Staphylococcus aureus 6×106 bacteria/ml Negative Positive
Neisseria meningitides 105 organisms/ml Negative Positive
Streptococcus sp. Group A 108 organisms/ml Negative Positive
Streptococcus sp. Group B 6×106 bacteria/ml Negative Positive
Streptococcus sp. Group C 6×106 bacteria/ml Negative Positive
Influenza A Virus H3N2 CEID50 ≧102 per 0.2 ml Negative Positive

 

List 2 

 

Potential Cross-Reactant

 

Concentration

Results
Negative Specimen Spiked with Positive Specimen
Adenovirus (e.g. C1 Ad. 71)-Type 7A 2.01 x104 U/ml Negative Positive
Enterovirus (e.g. EV68) 7.16 x104 TCID50/ml Negative Positive
Human Metapneumovirus (hMPV) 5.43 x105 TCID50/ml Negative Positive
Influenza A H1N1 (New Cal/20/99) 1.64 x106 U/ml Negative Positive
Influenza B (Florida/02/06) 2.01 x104 U/ml Negative Positive
ParaInfluenza virus 1 1.30×108 TCID50/ml Negative Positive
ParaInfluenza virus 2 1.64×106 U/ml Negative Positive
ParaInfluenza virus 3 9.44×105 U/ml Negative Positive
ParaInfluenza virus 4 4.03 x106 U/ml Negative Positive
Respiratory syncytial virus-Type A 5.43 x105 U/ml Negative Positive
Rhinovirus (Type 1A) 5.07 x104 U/ml Negative Positive
Bordetella pertussis 1.61 x109 CFU/ml Negative Positive
Candida albicans 8.96 x107 CFU/ml Negative Positive
Haemophilus Influenzae 7.76 x107 CFU/ml Negative Positive
Legionella pneumophila 2.69 x109 CFU/ml Negative Positive
Mycobacterium tuberculosis 9.80 x106 CFU/ml Negative Positive
Mycoplasma pneumoniae 4.51 x107 CCU/ml Negative Positive
Pneumocystis jirovecii (PJP)-S. cerevisiae Recombinant 4.93 x107 CFU/ml Negative Positive

List 2 Continued

 

Potential Cross-Reactant

 

Concentration

Results
Negative Specimen Spiked with Positive Specimen
Pseudomonas aeruginosa 1.21 x109 CFU/ml Negative Positive
Staphylococcus epidermis 1.73 x109 CFU/ml Negative Positive
Streptococcus pneumoniae 3.23 x108 CFU/ml Negative Positive
Streptococcus pyogenes 2.34 x108 CFU/ml Negative Positive
Streptococcus salivarius 1.17 x108 CFU/ml Negative Positive
Human coronavirus 229E 5.96 x104 TCID50/ml Negative Positive
Human coronavirus OC43 1.50 x105 TCID50/ml Negative Positive
Human coronavirus NL63 2.43 x104 TCID50/ml Negative Positive
MERS-coronavirus 4.51 x105 TCID50/ml Negative Positive

 

List 3

 

Potential Cross-Reactant

 

Concentration

Results
Negative Specimen Spiked with Positive Specimen
Escherichia coli 2.0×107 organisms/ml Negative Positive
Recombinant Hepatitis C Virus 1mg/ml Negative Positive
Recombinant Hepatitis B Virus 1 µg/ml Negative Positive
Recombinant Cytomegalo virus 0.066mg/ml Negative Positive
Recombinant Epstein-Barr Virus 0.4mg/ml Negative Positive
Recombinant Herpes Simplex Virus-2 (HSV-2) 0.11mg/ml Negative Positive
Recombinant Human Immunodeficiency Virus-1 (HIV-1) 0.407mg/ml Negative Positive

 

 

14. REFERENCES

  • Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164.
  • Cui J, Li F, Shi Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019; 17:181-192.
  • Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. TrendsMicrobiol 2016;24:490-502.
  • Coronavirus disease 2019 (COVID-19) Situation Reports. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports
  • Liu L, Liu W et A preliminary study on serological assay for severe acute 2 respiratory syndrome coronavirus 2 (SARS-CoV-2) in 238 3 admi<ed hospital patients. Available from: https://www.medrxiv.org/content/10.1101/2020.03.06.20031856v1.full.pdf
  • UN – COVID-19 FREQUENTLY ASKED QUESTIONS. Available from: https://www.un.org/sites/un2.un.org/6les/new_dhmosh_covid-19_faq.pdf
  • Juan juan Zhao al, Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019, Clinical Infectious Diseases, ciaa344,h<p://doi.org/10.1093/cid/ciaa344.
  • Structure, function and antigenicity of the SARS-CoV-2 spike Journal pre-proof DOI:10.1016/ j.cell. 2020.02.058.
  • US Food and Drug Administration (FDA). Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Issued March 16, 2020. Docket Number FDA-2020- D-0987.

 

 

15. DATE OF ISSUE

SARS-CoV-2 Antigen Rapid Test Cassette insert. Version 1, December 29th, 2020

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Weight .2 lbs
Dimensions 6 × 9 × .2 in
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