SAFECARE Covid-19 Antigen Rapid Test Kit Instruction Manual

SAFECARE Covid-19 Antigen Rapid Test Kit

ForMedical professional in vitro diagnostic use only.

INTENDED USE

The COVID-19 Antigen Rapid Test Kit (Swab) is a lateral flow immunoassay intended for qualitative detection of nucleocapsid protein antigen in direct nasal swabs or nasopharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
The COVID-19 Antigen Rapid Test Kit (Swab) does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in nasal swabs 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 onset beyond seven days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. 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 COVID-19 Antigen Rapid Test is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests.

PRINCIPLE

The COVID-19 Antigen Rapid Test Kit (Swab) is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from nasal swab or nasopharyngeal swab specimens.
SARS-CoV-2 specific antibodies are immobilized onto the test region of the membrane and combined with other reagents/pads to construct a test strip.
During testing, the specimen reacts with anti-COVID-19 antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the reagents in test line region. Therefore, if the specimen contains COVID-19 antigen, a colored line will appear in test line. If the specimen does not contain COVID-19 antigen, no colored line will appear in the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appeared in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

KIT COMPONENTS

• Individually packed test devices: Each device contains a strip with colored conjugates and reactive reagents pre-spreaded at the corresponding regions
• Extraction tube: For specimens preparation
• Extraction buffer: For specimens extraction
• Workstation: For placing extraction tube
• Nasal Swab: For specimens collection
• Package insert: For operation instruction

MATERIALS REQUIRED BUT NOT PROVIDED

• Timer

WARNINGS AND PRECAUTIONS

• Do not use after expiration date. Do not use if pouch is damaged or open. Do not reuse the tests.
• Do not mix components from different kit lots. Avoid cross-contamination of specimens by using a new specimens collection container for each specimens obtained.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing 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 being tested.
• Humidity and temperature can adversely affect results.
• The extraction buffer contains a salt solution if the solution contacts the skin or eyes, flush with copious amounts of water.
• Discard the using testing materials in accordance with local regulations.

REAGENT PREPARATION AND STORAGE INSTRUCTIONS

Store unused test devices unopened at 4°C-30°C. If stored at 4°C-8°C, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit over 30°C.

SPECIMEN COLLECTION AND HANDLING

Specimen Collection

• Inadequate specimen collection or improper specimen handling may yield a false result.

• Prior to collecting the nasal swab, the patient should be instructed to blow their nose.

• Nasal Swabbing:

  1. Insert the swab into one nostril of the patient. The swab tip should be inserted up to 2.5 cm (1 inch) from the edge of the nostril. Roll the swab 5 times along the mucosa inside the nostril to ensure that both mucus and cells are collected.
  2. Using the same swab, repeat this process for the other nostril to ensure that an adequate sample is collected from both nasal cavities.
  3. Withdraw the swab from the nasal cavity.
     

• Nasopharyngeal Swabbing:

  1. Tilt the patient’s head back. Insert the swab through the nostril that presents the most secretion under visual inspection.
  2. Keep the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab several times.
  3. Leave the swab in place for several seconds then remove it from the nasopharynx.
     

Specimens Transport and Storage:
Specimens should be tested as soon as possible. If transport of the samples is required, the following transport media are recommended and have been tested and shown not to interfere with the performance of the test: Hank’s balance Mkd salt solution, M5 media, or saline. Alternatively, samples may be stored refrigerated (2-8℃) or at room temperature (15-30℃) in a clean, dry, closed container for up to 8 hours before testing.

Specimen Preparation

Squeeze the buffer vial and add all the extraction buffer into the extraction tube, and put it on the workstation.
Insert the swab into the extraction tube which contains buffer. Rotate the swab at least 10 times while pressing the swab against the bottom and side of the extraction tube.
Pinch the extraction tube with fingers and roll the swab head against the inside of the Extraction tube when you remove it to release as much liquid as possible. The extracted solution will be used as test specimen.
Insert a dropper tip into the specimen extraction tube tightly.

ASSAY PROCEDURE

Allow the test device and specimens to equilibrate to room temperature(15-30°C or 59-86°F) prior to testing. For best results, the test should be performed in one hour.

1. Remove the test device from the sealed pouch.
2. Reverse the specimen extraction tube, holding the specimen extraction tube upright, transfer 3 drops to the specimen well(S) of the test device, then start the timer.
3. Wait for colored lines to appear. Interpret the test results at 10-15 minutes. Do not read results after 20 minutes.

INTERPRETATION OF ASSAY RESULT

POSITIVE RESULT

A colored line appears in the control line region (C) and a colored line appears in test line region (T).
*NOTE: The intensity of the color in the test line region will vary depending on the concentration of COVID-19 antigen in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE RESULT

A colored line appears in the control line region (C) and no line appears in test line region (T).

INVALID RESULT

No line appears in control line region (C). Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

QUALITY CONTROL

1. Internal Control: This test contains a built-in control feature, the C band. The C line develops after adding sample solution. Otherwise, review the whole procedure and repeat test with a new device.
2. External Control: Good Laboratory Practice recommends using the external controls, positive and negative to assure the proper performing of the assay.

PERFORMANCE CHARACTERISTICS

1. Clinical study: A side-by-side comparison was conducted using the research reagent and referencing reagent. Compare with RT-PCR:
   | Used Sample Matrix: Nasopharyngeal Swab| Used Sample Matrix: Nasal Swab| All Samples
   ---|---|---|---
   PCR Result| Total| PCR Result| Total| PCR Result| Total
   Positive| Negative| Positive| Negative| Positive| Negative
   Safecare Test| Positive| 131| 1| 132| 118| 1| 119| 249| 2| 251
   Negative| 4| 179| 183| 3| 165| 168| 7| 344| 351
   Total| 135| 180| 315| 121| 166| 287| 256| 346| 602
   Relative Sensitivity| 97.04% (92.59%～99.19%)| 97.52% (92.93%～99.49%)| 97.27% (94.45%～98.89%)
   Relative Specificity| 99.44% (96.94%～99.99%)| 99.40% (96.69%～99.98%)| 99.42% (97.93%～99.93%)
   Overall Agreement| 98.41% (96.33%～99.48%)| 98.61% (96.47%～99.62%)| 98.50% (97.18%～99.31%)
2. Cross-reactivity: Cross-reactivity studies are performed to demonstrate that the test does not react with the following micro organisms in the table below.
   Cross-Reactant| Concentration| Cross-Reactant| Concentration
   ---|---|---|---
   Adenovirus| 1.0 x 105 TCID50 /mL| Influenza B| 1.0 x 105 TCID50 /mL
   Human metapneumovirus (hMPV)| 1.0 x 105 TCID50 /mL| Respiratory Syncytial Virus| 1.0 x 105 TCID50 /mL
   Rhinovirus| 1.0 x 105 TCID50 /mL| Bordetella pertussis| 1.0 x 105 TCID50 /mL
   Enterovirus| 1.0 x 105 TCID50 /mL| Chlamydia pneumoniae| 1.0 x 105 TCID50 /mL
   Human coronavirus OC43| 1.0 x 105 TCID50 /mL| Haemophilus influenzae| 1.0 x 105 TCID50 /mL
   Human coronavirus 229E| 1.0 x 105 TCID50 /mL| Legionella pnuemophila| 1.0 x 105 TCID50 /mL
   Human coronavirus NL63| 1.0 x 105 TCID50 /mL| Mycoplasma pneumoniae| 1.0 x 105 TCID50 /mL
   Human parainfluenza virus 1| 1.0 x 105 TCID50 /mL| Streptococcus pneumoniae| 1.0 x 105 TCID50 /mL
   Human parainfluenza virus 2| 1.0 x 105 TCID50 /mL| Streptococcus pyogenes| 1.0 x 105 TCID50 /mL
   Human parainfluenza virus 3| 1.0 x 105 TCID50 /mL| Mycobacterium tuberculosis| 1.0 x 105 TCID50 /mL
   Human parainfluenza virus 4| 1.0 x 105 TCID50 /mL| Staphylococcus aureus| 1.0 x 105 TCID50 /mL
   Influenza A| 1.0 x 105 TCID50 /mL| Candida albicans| 1.0 x 105 TCID50 /mL
   MERS| 1.0 x 105 TCID50 /mL| |
3. Interference: The following endogenous interference substances were evaluated at the concentrations listed and no effect was found.
   Whole blood (2%), three OTC nasal sprays (10%), three OTC nasal drop (25%), three nasal mouthwashes (25%), 4-Acetamidophenol (10mg/ml), Acetylsalicylic acid (20mg/ml), Chlorpheniramine (5 mg/ml), Dextromethorphan (10mg/ml), Diphenhydramine (5mg/ml), Ephedrine (20mg/ml), Guaiacol glyceryl ether (20mg/ml), Oxymetazoline (10mg/ml), Phenylephrine (100mg/ml), Phenylpropanolamine (20mg/ml)

LIMITATIONS OF TEST

1. For professional in vitro diagnostic use and should be only for the detection of SARS-CoV-2 antigen, not for any other viruses or pathogens.
2. This test detects both viable (live) and non-viable SARS-CoV-2. Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.
3. The performance was evaluated using the procedures provided in this product insert only. Modifications to these procedures may alter the performance of the test.
4. A negative test result may occur if the level of antigen in a sample is below the detection limit of the test. If the test result is negative but clinical symptoms persist, additional testing using other clinical methods is recommended. As with all diagnostic tests, a confirmed diagnosis should only be made by physician after all clinical and laboratory findings have been evaluated.
5. Negative test results are not intended to rule in other non-SARS viral or bacterial infections.
6. Positive and negative predictive values are highly dependent on prevalence. False positive test results are more likely during periods of low COVID activity when prevalence is moderate to low.
7. False negative results may occur if a specimen is improperly collected, transported, or handled.
8. Children tend to shed virus for longer periods of time than adults, which may result in differences in sensitivity between children and adults.
9. If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is required.

REFERENCES

1. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164.
2. Masters PS, Perlman S. Coronaviridae. In: Knipe DM, Howley PM, eds. Fields virology. 6th ed. Lippincott Williams & Wilkins, 2013:825-58.
3. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016;24:490-502.
4. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019;17:181-192.
5. Wong G, Liu W, Liu Y, Zhou B, Bi Y, Gao GF. MERS, SARS, and Ebola: the role of super-spreaders in infectious disease. Cell Host Microbe 2015;18:398-401.

INDEX OF SYMBOLS

| Do not reuse| | For in vitro diagnostic use only
---|---|---|---
| Stored between 4-30℃| | Consult instruction for use
| Date of Manufacture| | Lot number
| Use-by date| | Contains sufficient for tests
| Manufacturer| | Authorized Representative in the European Community

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