LEPU MEDICAL SARS-CoV-2 Antigen Rapid Test Kit User Manual
- June 6, 2024
- LEPU MEDICAL
Table of Contents
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
Product name
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
Model
1 test/kit; 5 tests/kit; 10 tests/kit; 25 tests/kit; 50 tests/kit.
Intended Use
The product is intended for the qualitative detection of antigen against SARS-
CoV-2 in clinical samples (nasal swab).
Summary
Coronavirus, as a large virus family, is a single positive-stranded RNA virus
with an envelope. The virus is known to cause major illnesses such as colds,
Middle East Respiratory Syndrome (MERS), and Severe Acute Respiratory Syndrome
(SARS). The core protein of SARS-CoV-2 is the N protein (Nucleocapsid), which
is a protein component located inside the virus. It is relatively conserved
among β-coronaviruses and is often used as a tool for the diagnosis of
coronaviruses. ACE2, as a key receptor for SARS-CoV-2 to enter cells, is of
great significance for the research of viral infection mechanisms.
Principle
The current test card is based on the specific antibody-antigen reaction and
immune analysis 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 the capillary effect and are 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 capture 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.
Component
The product consists of test cards, Instructions for use, sample treatment solutions. And in each test card bag, includes one SARS-CoV-2 antigen detection card and one package of desiccants.
Model
| Test card| Instructions for use|
Sample treatment solution
---|---|---|---
I test/kit| I test| I| 1mlx1
5 tests/kit| 5 tests| I| 1mIx’
10tests/kit| 10 tests| I| 2m1x1
25 tests/kit| 25 tests| I| 3m1x2
50 tests/kit| 50 tests| I| 5m1x2
Each test card bag contains one test card and one package of desiccants.
The test card consists of a gold standard mat (coated with colloidal gold-
labeled SARS-CoV-2 N protein monoclonal antibody), sample mat, nitrocellulose
membrane (Test area (T) is coated with a 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.
Storage and Stability
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.
Sample Requirements
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: gently and slowly insert the swab into the nasopharynx
through the nasal cavity. When resistance is encountered, the swab will arrive
at the posterior nasopharynx. After a few seconds of suction, gently rotate
the swab, then take out the swab to obtain the nasal swab sample.
Sample preservation: after sample collection, please complete the test within
1 hour.
The sample should come to room temperature before testing.
Test Method
Please read the instruction for use carefully before performing the test. Before testing, restore the reagents and sample to room temperature.
- 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.
- Add 6 drops of the diluent into well A. Do not drop the diluent into the other wells.
- During the test, the test card should be placed on the horizontal desktop. The test card should be fixed and do not remove 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.
The Explanation of the Testing Results
• Positive (+): There appear purple stripes in both the quality control area
(C) and either test area (T). • Negative (-): There is only one purple stripe
in the quality control area (C), and without purple stripe in either test area
(T). • Invalid: There is no purple stripe in the quality control area (C), or
there is a 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 the 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.
Product Performance Index
-
Physical Property
1.1 Appearance
The test card should be clean and integral, no burrs, no damage, no pollution; the material should be firmly
attached; the label should be clear and not damaged. The sample dilution should be clear without impurities
and flocs.
1.2 Liquid migration speed
The liquid migration speed should be no less than 10mm/min.
1.3 Membrane Strip Width
The membrane strip width of the testing card should be≥2.5mm.
1.4 The preparation quantity of the diluent for the samples
The volume of the diluents for the sample is no less than the indicated value. -
Detection Limit
For the detection of sensitivity reference material, the positive detection rate should be no less than 90%. -
Negative reference products compliance rate
For the detection of negative reference material, the negative detection rate should be 100%. -
Positive reference products compliance rate
For the detection of positive reference material, the positive detection rate should be 100%. -
Repeatability
For the detection of enterprise reference material P2 and P4, the results should be positive and the color
rendering should be uniform. -
Cross-reactivity
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 pneumonia, Human metapneumovirus. -
Clinical Performance
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 the nucleic acid method (PCR) using the collected clinical samples. The results were summarized in the table below:
SARS-CoV-2 Antigen Rapid
Test Kit
|
Nucleic acid detection method (PCR)
---|---
Positive| Negative
Positive| 69| 1
Negative| 6| 134
Diagnostic Specificity| 92.00% (95%CI: 83.63%-96.28%)| /
Diagnostic Specificity| /| 99.26% (95%CI: 95.92%-99.87%)
Precautions
-
The test is only suitable for professionals to use in vitro auxiliary diagnosis. Do not use expired products.
-
Do not freeze or use after the expiration date (see the packaging for the expiration date).
-
Avoid excessive temperature and humidity in the experimental environment. The reaction temperature should be 15-30 ° C and the humidity should be below 70%.
-
The test card bag contains desiccant, and it should not be taken orally.
-
When testing, please wear protective clothing, a medical mask, gloves, and goggles.
-
Do not use the test card with broken single packaging, unclear marks, and past the expiration date.
-
Dispose of used specimens, test cards, and other waste in accordance with relevant local laws and regulations.
-
The test card should be used within 1 hour after being taken out of the aluminum foil bag.
-
The users should take samples according to the requirements of IFU.
-
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. -
Do not drop the diluent into the wrong well.
-
During the test, the test card should be placed on the horizontal desktop. The test card should be fixed and do not remove test card.
Explanation of Symbols
| DO NOT USE IF PACKAGE IS DAMAGED| | CONSULT
INSTRUCTIONS
FOR USE
---|---|---|---
| DO NOT REUSE| | USE-BY DATE
| TEMPERATURE LIMIT| | DATE OF MANUFACTURER
| MANUFACTURER| | BATCH CODE
| KEEP AWAY FROM
SUNLIGHT
| | KEEP DRY
| IN VITRO
DIAGNOSTIC
MEDICAL DEVICE| | CE MARK
| AUTHORIZED
REPRESENTATIVE
IN THE EUROPEAN
COMMUNITY| |
Basic Information
Beijing Lepu Medical Technology Co., Ltd.
Address: Building 7-1 No.37 Chaoqian Road, Changping District, Beijing,
102200, P.R. China
Tel: +86-10-80123964
Email: [email protected]
Web: en.lepumedical.com
Lepu Medical (Europe) Cooperatief U.A.
Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, The Netherlands
Tel: +31-515-573399 Fax: +31-515-760020
Approval Date and Revision Date of the Instruction
Approved on 2nd, Sept., 2020;
Version number: CE-InCG27 REV.05