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Surescreen Diagnostics, COVID-19 ANTIGEN Rapid Test Kit Cassette, 25 Tests
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Surescreen Diagnostics, COVID-19 ANTIGEN Rapid Test Kit Cassette, 25 Tests

SureScreen's COVID-19 rapid test identifies COVID-19 present in a swab sample and gives a qualitative yes/no result within 15 minutes.

The test is perfect for screening quickly at the patient side for the presence of COVID-19. The test can be used as a companion to the antibody test to increase the window of detection.

Implementing rapid screening for COVID-19 has huge time and cost savings when compared to, or integrated into, laboratory screening, and will help to control the spread of the virus by identifying active infection rapidly and accurately.

A swab is used to sample from either the nose or throat (nasopharyngeal or oropharyngeal sample) and introduced into the test cassette by suspension in a buffer solution.

CE approved for professional in-vitro diagnostic (IVD) use only.

For up-to-the-moment product information and FAQ's, please consult the manufacturers website HERE:

https://www.surescreen.com/products/covid-19-coronavirus-antigen-test-casette

  • PACKS OF 25 TESTS OR MULTIPLES THEREOF.
  • 1 BOTTLE OF BUFFER SOLUTION PER PACK OF 25 TESTS, SO THE TESTS CANNOT BE FURTHER DISTRIBUTED AS EXTRA BUFFER IS NOT AVAILABLE.
  • REFER TO IFU PRODUCT INSERT (PDF LINK BELOW) BEFORE PURCHASING AND BEFORE USE.
  • UNIT COST REDUCES AS QUANTITY INCREASES (PRICING ON REQUEST).
  • LIFESPAN 24 MONTHS FROM DATE OF MANUFACTURE.

INTENDED USE

The SureScreen Diagnostics COVID-19 Antigen Rapid Test is an in vitro immunochromatographic assay for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from nasopharyngeal secretions and oropharyngeal secretions from individuals suspected of COVID-19 within the first two weeks of symptom onset.

SUMMARY

COVID-19(Corona Virus Disease) is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. The most common symptoms of COVID-19 are fever, tiredness, and dry cough. Some patients may have aches and pains, nasal congestion, runny nose, sore throat or diarrhea. These symptoms are usually mild and begin gradually. Some people become infected but don’t develop any symptoms and don't feel unwell. Most people (about 80%) recover from the disease without needing special treatment. Around 1 out of every 6 people who gets COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high blood pressure, heart problems or diabetes, are more likely to develop serious illness. About 2% of people with the disease have died. People with fever, cough and difficulty breathing should seek medical attention. People can catch COVID-19 from others who have the virus. The disease can spread from person to person through small droplets from the nose or mouth which are spread when a person with COVID-19 coughs or exhales. These droplets land on objects and surfaces around the person. Other people then catch COVID-19 by touching these objects or surfaces, then touching their eyes, nose or mouth. People can also catch COVID-19 if they breathe in droplets from a person with COVID-19 who coughs out or exhales droplets. Most estimates of the incubation period for COVID-19 range from 1-14 days.

PRINCIPLE

The SureScreen Diagnostics COVID-19 Antigen Rapid Test detects SARS-CoV-2 viral antigens through visual interpretation of color development. Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated to colored particles are immobilized on the conjugated pad. A sample is added to the extraction buffer which is optimized to release the SARS-CoV-2 antigens from specimen.

During testing, the extracted antigens bind to anti-SARS-CoV-2 antibodies conjugated to colored particles. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies at the test region. Excess colored particles are captured at the internal control zone.

The presence of a colored band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working.

REAGENTS

  • Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane.
  • Anti-SARS-CoV-2 antibodies conjugated to colored particles are immobilized on the conjugated pad.
  • A sample is added to the extraction buffer which is optimized to release the SARS-CoV-2 antigens from specimen.

PRECAUTIONS

  • For professional in vitro diagnostic use only.
  • Do not use after expiration date.
  • Do not eat, drink or smoke in the area where the specimens or kits are handled.
  • The device contains material of animal origin and should be handled as a potential biohazard.
  • Handle all specimens as if they contain infectious agents.
  • Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
  • Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
  • The used tests, specimens and potentially contaminated material should be discarded according to the local regulations.
  • Humidity and temperature can adversely affect results.
  • Specimens must be mixed thoroughly before testing to ensure of a representative sample.
  • Failure to bring specimens and reagents to room temperature (15-30c) before use may decrease sensitivity.
  • Inaccurate or inapproproate specimen collection, storage, and transport may yield false negative test results.
  • Avoid skin contact with Buffer Solution.
  • If infection with SARS-CoV-2 is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control procedures and sent to state or local health departments for testing.
  • Viral isolation in cell culture and initial characterisation of viral agents recovered in cultures of SARS-CoV-2 specimens are NOT recommended, except in a BSL3 laboratory using BSL3 work practises.

STORAGE AND STABILITY

  • The kit can be stored at room temperature or refrigerated (2-30°C).
  • The test cassette is stable through the expiration date printed on the sealed pouch.
  • The test cassette must remain in the sealed pouch until use.
  • Do not use if the foil pouch has been compromised.
  • Do not use if the Buffer Solution is discoloured or turbid, this may be a sign of microbial contamination.
  • DO NOT FREEZE.
  • Do not use beyond the expiration date.

MATERIALS SUPPLIED PER BOX OF 25 TESTS:

QuantityItem
25Test Cassette (Packed in individual sterile pouches)
25Swabs (Packed in individual sterile pouches)
25Extraction Tubes
25Extraction Tube Nozzles
1Extraction Tube Holder (6 Port)
2Buffer Solution bottles
1IFU Product Insert
1Procedure Card

Materials required but not provided;

  • Timer / Stopwatch

SPECIMEN COLLECTION AND PREPARATION

Nasopharyngeal swab (NP swab):

  1. Remove the swab from its packing
  2. Insert the swab into the nostril parallel to the palate. Rotating against the nasal wall.(to ensure swab contains cells as well as mucus)
  3. Process the swab as soon as possible after collecting the specimen

Oropharyngeal swab (OP swab):

  1. Remove the swab from its packing
  2. Insert the swab completely from the mouth into the throat, centering on the red part of the throat wall and maxillary tonsils and rub the bilateral throat tonsils and throat wall moderately. Avoid touching the tongue and remove the swab
  3. Process the swab as soon as possible after collecting the specimen

Note:

  1. Use only synthetic fiber swabs with plastic shafts. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit further testing.
  2. Swabs specimens should be tested as soon as possible after collection. Use freshly collected specimens for best test performance.
  3. If not tested immediately, swab specimens may be stored at 2-8°C for 24 hours after collection.
  4. Do not use specimens that are obviously contaminate with blood, as it may interfere with the flow of sample with the interpretation of test results.

DIRECTIONS FOR USE

  1. Bring devices, reagents, and specimens and/or controls to room temperature (15~30°C) before use.
  2. For each specimen, open the foil pouch just before testing and remove the test device, and put it on a clean, level surface. Label the tube with the patient identification. For best results, the assay should be performed within one hour.
  3. Gently mix extraction buffer. Add 10 drops into the extraction tube.
  4. Insert the swab into the extraction tube. Mix well and squeeze the swab 10-15 times by compressing the walls of the tube against the swab. Stand for 2 minutes.
  5. Roll the swab head against the inner wall of the tube as you remove it. Try to release as much liquid as possible. Dispose of the used swab in accordance with your biohazard waste disposal protocol.
  6. Insert nozzle into sample extraction tube. Invert the tube and add 2 drops of solution into the sample well by gently squeezing the tube.
  7. Read results at 15 minutes.

INTERPRETATION OF RESULTS

Note:

  1. The color intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen.
  2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

QUALITY CONTROL

An internal procedural control is included in the test. A coloured line appearing in the control line region (C) is an internal valid procedural control, it confirming adequate membrane wicking. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

LIMITATIONS

  1. The SureScreen Diagnostics COVID-19 Antigen Rapid Test is for professional in vitro diagnostic use and should only be used for the qualitative detection of SARS-CoV-2 antigen. The intensity of color in a positive band should not be evaluated as “quantitative or semi-quantitative”.
  2. Both viable and nonviable SARS-CoV-2 viruses are detectable with the SureScreen Diagnostics COVID-19 Antigen Rapid Test.
  3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test but should only be made by the physician after all clinical and laboratory findings have been evaluated.
  4. Failure to follow the TEST PROCEDURE and RESULT INTERPRETATION may adversely affect test performance and/or invalidate the test result.
  5. Results obtained with this assay, particularly in the case of weak test lines that are difficult to interpret, should be used in conjunction with other clinical information available to the physician.
  6. Negative results do not preclude SARS-CoV-2 infection and should be confirmed via molecular assay.

PERFORMANCE CHARACTERISTICS

Analytical Sensitivity (Limit of Detection):
The limit of detection was determined with a quantified SARS-CoV-2 virus and has been evaluated at 2x102.4 TCID50/ml. The limit of detection was also determined with recombinant SARS-CoV-2 nucleoprotein and has been evaluated at 0.4 ng/ml.

Clinical Evaluation:
Clinical evaluation was performed to compare the results obtained by the SureScreen Diagnostics COVID-19 Antigen Rapid Test and a real-time Polymerase Chain Reaction (RT-PCR) comparator assay. Patients who presented with symptoms within 14 days were included in the study. The performance was evaluated for 85 prospective clinical specimens which included 43 specimens of nasopharyngeal swab and 42 specimens of oropharyngeal swab. 55 positive specimens and 30 negative specimens were confirmed by RT-PCR. Another 131 retrospective clinical specimen who are either asymptomatic or with mild symptoms (within 14 days of symptom onset) were collected to confirm the specificity. All of these are confirmed negative through PCR. 59 specimens were of nasopharyngeal swab and 72 specimens of oropharyngeal swab. The performance of the SureScreen Diagnostics COVID-19 Antigen Rapid Test Device results based on the various parameters is summarized below:

Table 1: Oropharyngeal Swab Specimen vs RT-PCR Positive
Days from onset of symptomsPCR Positive at any timeAntigen PositivePPA95% Confidence Interval
66100%51.68% to 100%
8-14242291.67%71.52% to 98.54%
302893.33%76.49% to 98.83%
Table 2: Nasopharyngeal Swab Specimen vs RT-PCR Positive
Days from onset of symptomsPCR Positive at any timeAntigen PositivePPA95% Confidence Interval
44100%39.57% to 100%
8-14212095.24%74.13% to 99.75%
252496.00%77.67% to 99.79%
Table 3: Oropharyngeal & Nasopharyngeal Swab Specimen vs RT-PCR Positive
Days from onset of symptomsPCR Positive at any timeAntigen PositivePPA95% Confidence Interval
1010100%65.55% to 100%
8-14454293.33%80.69% to 98.26%
555294.55%83.93% to 98.58%
Table 4: Summary of Surescreen Diagnostic COVID-19 Antigen Rapid Test Clinical Evaluation
 RT-PCR POSITIVERT-PCR NEGATIVETOTAL
POSITIVE52052
NEGATIVE3161164
TOTAL55161216

Relative Sensitivity: 94.55% 83.93%~98.58%) *

Relative Specificity: 100% (97.1%~100%)*

Overall Agreement: 98.61% (95.66%~99.64 %)*

*95% Confidence Interval

Cross Reactivity:

Cross reactivity with the following organisms has been studied. Samples positive for the following organisms were found negative when tested with the SureScreen Diagnostic COVID-19 Antigen Rapid Test (Nasopharyngeal/Oropharyngeal Swab).

Adenovirus
Bordetella Parapertussis
Chlamydia Pneumoniae
Coxsackie Virus A16
Epstein Barr Virus
Group C Streptococcus
HCoV-229E
HCoV-HKU1
HCoV-NL63
HCoV-OC43
Human Metapneumovirus
Influenza A (H1N1) pdm09
Influenza A (H3N2)
Influenza A (H5N1)
Influenza A (H7N7)
Influenza A (H7N9)
Influenza B Victoria Lineage
Influenza B Yamagata Lineage
Legionella Pneumophila
Measles Virus
Mump Virus
Mycoplasma Pneumoniae
Norovirus
Parainfluenza 1/2/3 Virus
Respiratory Synctial Virus
Rhinovirus
Staphylococcus Aureus
Streptococcus Agalactiae
Streptococcus Pyrogenes
Streptocuccus Pneumoniae

Interfering Substances:

The following substances, naturally present in respiratory specimens or that may be artificially introduced into the respiratory tract, were evaluated at the concentrations listed below. None of them were found to affect test performance of the SureScreen Diagnostics COVID-19 Antigen Rapid Test Device.

SubstanceConcentration
3 OTC nasal sprays10%
3 OTC mouthwashes10%
3 OTC throat drops10%
4-acetamidophenol10 mg/ml
Acetylsalicylic acid20 mg/ml
Albuterol20 mg/ml
Chlorpheniramine5 mg/ml
Dexamethasone5 mg/ml
Dextromethorphan10 mg/ml
Diphenhydramine5 mg/ml
Doxylaminesuccinate1 mg/ml
Flunisolide3 mg/ml
Guaiacol glyceryl ether20 mg/ml
Mucin1%
Mupirocin250 ug/ml
Oxymetazoline10 mg/ml
Phenylephrine10 mg/ml
Phenylpropanolamine20 mg/ml
Relenza ® (zanamivir)20 mg/ml
Rimantadine500 ng/ml
Tamiflu ® (oseltamivir)100 mg/ml
Tobramycin40 mg/ml
Triamcinolone14 mg/ml

Literature References:

  1. Forni, D., Cagliani, R., Clerici, M. & Sironi, M. Molecular evolution of human coronavirus genomes. Trends Microbiol. 25, 35–48 (2017).
  2. Ithete, N. L. et al. Close relative of human Middle East respiratory syndrome coronavirus in bat, South Africa. Emerg. Infect. Dis. 19, 1697–1699 (2013).
Shipping Information
ProductPackaged Dimensions & WeightCustoms Tariff Code
'Inner' Box of 25 Tests16.5 x 12 x 6.5 cms, 0.21 Kg NET / 17 x 13 x 7 cms, 0.24 Kg Gross3822000000
'Outer' Box of 1000 Tests (40 'Inner' Boxes of 25 Tests)64 x 38 x 31 cms, 9.85 Kg Gross.3822000000

Download Surescreen COVID-19 Antigen Rapid Test - IFU Product Insert PDFDownload Surescreen COVID-19 Antigen Rapid Test - IFU Product Insert PDF

Download Surescreen COVID-19 Antigen Rapid Test - Technical Whitepaper PDFDownload Surescreen COVID-19 Antigen Rapid Test - Technical Whitepaper PDF

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£266.00

Product CodeSURGT0RL90
ConditionNew

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