Thanks to its simple handling with swabbing in the anterior nasal cavity and the uncomplicated evaluation, the LEPU MEDICAL® rapid test saves considerable time in collection. The test results are available within 15 minutes.
The LEPU MEDICAL® rapid test detects the nucleocapsid (N) protein of the coronavirus. The test result is displayed by means of a test strip. The higher the volume of this protein, the darker the colour of the test strip. The evaluation of the LEPU MEDICAL® Antigen Rapid Test is therefore particularly easy and avoids incorrectly interpreted test results.
The SARS-CoV-2 Antigen Rapid Test is suitable for the qualitative detection of novel coronaviruses in saliva, sputum (each from the posterior oropharyngeal region) and stool specimens. It aids in the diagnosis of infection with new types of coronaviruses. The SARS-CoV-2 Antigen Rapid Test is intended to be used in conjunction with clinical manifestations and other laboratory test results to aid in the diagnosis of patients with suspected SARS-CoV-2 infection. The test is to be used only by medical personnel. The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab).
The current test card is based on the specific antibody-antigen reaction and immunoanalysis technology. The test card contains colloidal gold labeled SARS-CoV-2 N protein monoclonal antibody which is pre-coated on the combination pad, matched SARS-CoV-2 N protein monoclonal antibody immobilized on the Test area (T) and corresponding antibody in the quality control area (C). During testing, the N protein in the sample combines with the colloidal gold labeled SARS-CoV-2 N protein monoclonal antibody which is pre-coated on the combination pad. The conjugates migrate upward under capillary effect, and subsequently captured by the N protein monoclonal antibody immobilized in the Test area (T). The higher the contents of N protein in the sample, the more the conjugates captures and the darker the color in the test area is. If there is no virus in the sample or the virus content is lower than the detection limit, then there is no color demonstrated in the test area (T). Regardless of the presence or absence of the virus in the sample, a purple stripe will appear in the quality control area (C). The purple stripe in the quality control area (C) is a criterion for the judgment of whether or not there is enough sample and whether or not the chromatography procedure is normal.
For the detection of sensitivity reference material, the positive detection rate should be no less than 90%.
210 clinical samples based on the nucleic acid detection method (PCR) test results were obtained for testing, including 75 positive and 135 negative samples. The SARS-CoV-2 Antigen Rapid Test Kit was compared with nucleic acid method (PCR) using the collected clinical samples. The results were summarized in the table below:
|SARS-CoV-2 Antigen Rapid Test||Results||Positive||Negative|
Relative sensitivity: 69/(69+6)×100% = 92%
95% Confidence intervall: [0.8363,0.9628]
Relative specificity: 134/(1+134)×100% = 99,26%
95% Confidence intervall: [0.9592,0.9987]
Cross-reactivity: This test device has no cross reactivity with endemicity human coronavirus OC43, influenza a virus, influenza B virus, respiratory syncytial virus, adenovirus, EB virus, measles virus, cytomegalovirus, rotavirus, Norovirus, mumps virus, varicella zoster virus, mycoplasma pneumoniae, Human metapneumovirus.
|Materials provided||Quantity per box of 1||Quantity per box of 25|
|SARS-CoV-2 antigen detection card
||1 piece||25 pieces|
|Package of desiccant
||1 piece||25 pieces|
|Swab||1 piece||25 pieces|
|Sample treatment solution||1 x 1 ml||2 x 3 ml|
|Instructions for use
||1 piece||1 piece|
The product consists of test cards, Instructions for use, sample treatment solution. And in each test card bag, it includes one SARS-CoV-2 antigen detection card and one package of desiccant. The test card consists of gold standard mat (coated with colloidal gold labelled SARS-CoV-2 N protein monoclonal antibody), sample mat, nitrocellulose membrane (Test area (T) is coated with an SARS-CoV-2 N protein monoclonal antibody; the quality control area (C) is coated with goat anti-mouse antibody), absorbing paper, and hydrophobic stiff card.
It should be stored at 4°C~ 30°C, be kept dry and away from sunlight. The shelf life is 12 months. For per test card, it should be used within 1 hour after unsealing.
Production Date and Expiration date are shown in the package label.
The product is used to test the human nasal swab sample. Sample collection: During the collection procedures for samples, take care to make proper protection, and avoid direct contact with the sample. In case of accidental contact, disinfection treatment should be carried out in time and necessary measures should be taken. Nasal swab sample: During sampling, the swab head should be completely inserted into the nasal cavity and gently rotated 5 times. After removal, the swab head should be sampled in the other nasal cavity in the same way to ensure that enough samples are taken. Sample preservation: after sample collection, please complete the test within 1 hour. The sample should come to room temperature before testing.
|During sampling, the swab head should be completely inserted into the nasal cavity and gently rotated 5 times. After removal, the swab head should be sampled in the other nasal cavity in the same way to ensure that enough samples are taken.|
|Before the test, the double-sided adhesive protective layer should be removed in advance to prevent liquid splashing. If the double-sided adhesive protective layer is torn off after adding diluent, it is easy to cause liquid splashing.|
|Thread the swab sample through the bottom of well B into well A.|
|Add 6 drops of the diluent into well A. Do not drop the diluent into the other wells.Rotate the shaft ,two rounds each direction. During the test, the test card should be placed on the horizontal desktop. The test card should be fixed and do not remove the test card.|
|After covering the left side, gently press the adhesive position to make the two sides completely fit and start timing. Wait until the purple band appears. The test result should be read within 15-20 minutes.|
There appear purple stripes in both quality control area (C) and either test area (T).
There is only one purple stripe in the quality control area (C), and without purple stripe in either test area (T).
There is no purple stripe in the quality control area (C), or there is blue stripe in the quality control area (C), indicating incorrect operating procedures or the test card has already deteriorated. Under this condition, it must read the instruction for use again carefully, and then use the new test card to test again. If the problem still exists, stop using the products with same lot number and contact the local suppliers immediately.
Limitation of procedure
- The test results of this product should be comprehensively judged by the physician in combination with other clinical information, and should not be used as the only criterion;
- The product is used to test the SARS-CoV-2 antigen of the clinical sample.
Rapid tests are excluded from return and exchange.