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BIOEASY™
Diagnostic Kit for 2019-Novel Coronavirus（2019-nCoV）Ag Test Kit ( Fluorescence Immunochromatographic Assay)
CAT. NO.:YRLF04401025, YRLF04401025YRLF04401025YRLF04401025 FOR IN VITRO DIAGNOSTIC USE
This instruction for use (IFU) must be read carefully prior to use. Instruction for use must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions for use.
PACKING SPECIFICATION
1 Test/ Kit,20 Tests/ Kit, 25 Tests/ Kit, 50 Tests/ Kit, 100 Tests/ Kit INTENDED USE
This test is suitable for in vitro qualitative detection of 2019-Novel Coronavirus (2019-nCoV) antigens in human oropharyngeal swabs and deep sputum samples. It is used for the auxiliary diagnosis of whether the patient is infected with the 2019-nCov and other related diseases.
This product is for emergency use only in vitro during the pneumonia epidemic of the novel coronavirus (2019-nCoV) infection since December 2019. In use, the relevant requirements of the existing "Pneumonitis Diagnosis and Treatment Scheme for novel Coronavirus Infection" and "Pneumonitis Prevention and Control Scheme for novel Coronavirus Infection" should be complied with.
The novel coronavirus belongs to the novel coronavirus of the genus β, which has an envelope, the particles are round or oval, often polymorphic, and the diameter is 60
~ 140nm. Its genetic characteristics are significantly different from SARSr-CoV and MERSr-CoV. Current research shows that it has more than 85% homology with bat SARS-like coronavirus (bat-SL-CoVZC45). In vitro isolation and culture, 2019-nCoV can be found in human respiratory epithelial cells in about 96 hours, while it takes about 6 days to isolate and culture in Vero E6 and Huh-7 cell lines.
At present, the products that detect 2019-nCoV mainly include detection kits for fluorescent PCR and immunochromatography.
PRINCIPLE OF THE PROCEDURE
This kit uses the principle of double antibody sandwich reaction and fluorescent immunochromatographic analysis technology to qualitatively detect 2019-nCoV antigen in human oropharyngeal swabs and deep sputum samples.
During the test, if the test sample contains 2019-nCoV antigen, the 2019-nCoV antibody labeled with fluorescent particles (Eu-2019-nCoV-Ab) binds to the 2019-nCoV antigen in the sample to form “(Eu-2019-nCoV -Ab)-(2019-nCoV) ” reaction complex, the reaction complex moves forward along the nitrocellulose membrane under the action of chromatography, and binds to the 2019-nCoV coated
antibody pre-coated in the detection zone (T), to form
"(Eu-2019-nCoV-Ab)-(2019-nCoV-Ag)-(2019-nCoV-Ab)" double antibody sandwich, and finally form a reaction line with a fluorescent signal in the T region; Instead, when detect negative samples, no fluorescence signal reaction line was formed in the T region. Regardless of whether the sample to be tested contains the 2019-nCoV antigen, the control area (C) will always form a fluorescence reaction line. The detection card is detected by the matching fluorescent immunoanalyzer, and the result is interpreted.
REAGENTS AND MATERIALS SUPPLIED
• Test devices with desiccant in individual foil pouches
• 1 Sample Extraction buffer
• 25 Extraction Tube with drip head
• 1 Extraction Tube Holder
• 1 ID chip
• 1 Instructions for use
1. Ingredients of the Test device
2019-nCoV antibody Coated in the Test region on NC membrane Goat anti Chicken IgY polyclonal
antibody Coated in the control region on NC membrane 2019-nCoV antibody, Chicken
IgY Coated in the conjugate pad
Other test device supports /
2. The main component of the buffer is phosphate solution.
Note: The components in different batches of the kit cannot be mixed.
3.The ID card stores information such as the batch number of the kit, QR code information and threshold range.
MATERIALS REQUIRED BUT NOT PROVIDED The immunofluorescence analyzer
Transfer pipette Foam swabs Timer
STORAGE AND STABILITY
Kits should be stored in 2°C~30°Cin a cool, dark, dry place preservation, valid for 24 months(Tentative), frozen or in use after the period of validity of avoid by all means.
The test card should be in aluminum foil bag after opening, to the specified environment (temperature 2°C~35°C, humidity 40%~90%) used within 60 minutes.
The buffer should be used immediately after dropping into the dropper.
Production and expiration date can be see in the Label.
APPLICABLE EQUIPMENT
This product is only applicable to the Immunofluorescence Analyzer EASY-11, produced by Shenzhen Bioeasy Biotechnology Co., Ltd.
SAMPLE COLLECTION AND STORAGE
1. Collection of Oropharyngeal swab: insert the sterile swab completely into the throat from the mouth, center on the throat wall, upper jaw and the redness of tonsils, wipe it with moderate force and rotate it for 3 times to avoid touching the tongue. Then remove the swab.
2. Collection of Deep sputum: patients are instructed to have a deep cough while wearing a mask, and the sputum is collected and kept in a special clean container.
3. The samples should be used as soon as possible after being collected, otherwise they should be stored in a closed container and placed in a refrigerator at 2-8 ℃, but not longer than 24 hours, and can be stored for long periods at -70 ℃.
Cryopreserved samples should be equilibrated to room temperature before use TEST PROCEDURE
Sample processing:
Add 500µL(10 drops) of sample extraction buffer to the extraction tube, and then completely immerse the swab head in the sample extraction buffer in the tube.
Vigorously mix the solution by rotating the swab forcefully against the side of the tube at least 10 times(while submerged) or squeeze the tube 5 times by hand to ensure that the sample on the sampling swab is fully eluted into the sample extraction buffer.
Squeeze the swab head along the inner wall of the extraction tube to keep the liquid in the tube as much as possible. Discard the swab and cover the drip head to mix the liquid thoroughly.
500μL(10 drops)
Extraction Buffer Vigorously mix at least 10 times
Squeeze liquid from swab
Cover the droper head
Test operation
Before performing the test, you must read the instruction manual of the product and the operating manual of the fluorescent immunoanalyzer completely, and please restore the reagents to room temperature before the test. Under the condition of not recovering the room temperature, you cannot perform the experimental operation to avoid affecting the accuracy of the experimental results .
1. Instrument preparation: Turn on the power of the fluorescence analyzer, select the detection mode (quick test, standard test), read the reagent ID card, select the sample type and test item. The specific operation of the instrument is performed in accordance with the instruction manual of the corresponding model instrument.
2. Remove the test sample and the required reagents from the storage conditions and equilibrate to room temperature.
3. Unpack the aluminum foil bag, place the reagent card horizontally on the table and number it.
4. Add 100μL (2 drops ) of the processed sample to the sample well, and timed.
5. Test:
①Standard test：
After the sample is added, insert the test card into the instrument and click “start test”.The instrument automatically counts the time.After the reaction countdown ends in 10 minutes, the instrument automatically performs the test.
②Quick test：After adding the sample, insert the test card into the instrument after 10 minutes, and click "Start Test". The instrument will automatically test the test card. It will record, read and print test results. A test card that fails to be tested in time after the end of the 10-minute countdown of the reaction is considered to be an invalid test, and a new test card is required to retest the sample.
POSITIVE JUDGEMENT VALUE
The positive judgment threshold of this product is 0.005ng / mL.
The positive judgment value is only a reference guide for clinical diagnosis. The test results only reflect the current state of the sample. The diagnosis must be comprehensively evaluated in combination with clinical symptoms and other experimental results. It is recommended that each laboratory establish its own reference range based on actual conditions.
INTERPRETATION OF TEST RESULTS
This product can only perform qualitative analysis on the detection object. The applicable instrument automatically determines the positive or negative of the sample according to the comparison between the detection value of the detection line and the positive reference value, and directly outputs the qualitative result.
1. Positive (+): indicates that both the detection line and the control line detect a fluorescent signal, and the detection line detection value is ≥ 0.005ng / mL, which is interpreted as positive.
2. Negative (-): indicates that the fluorescent signal is detected on the control line, and the detection value of the detection line is＜0.005ng / mL, which is interpreted as negative.
3. Invalid (F): indicates that no fluorescent signal is detected or only the fluorescent signal is detected on the detection line, the interpretation is invalid, and the sample should be re-tested as required.
4 5 LIMITATIONS
1. The test results of this product cannot be used as a basis for diagnosis.
Comprehensive judgment should be made based on clinical symptoms, epidemiological conditions and further clinical data.
2. In the early stage of infection, the test result may be negative because the 2019-nCoV antigen or low antigen level has not yet appeared in the sample.
3. Due to the limitation of the test method, the negative test result of this product cannot exclude the possibility of infection.
4. This product can only qualitatively detect 2019-nCoV antigens in pharyngeal swabs and deep cough sputum samples. It cannot determine the antigen content in the samples.
PERFORMANCE CHARACTERISTIC (1) Sensitivity
Sample
Diagnostic Kit for 2019-Novel Coronavirus（2019-nCoV）Ag Test Kit ( Fluorescence Immunochromatographic Assay)
Bioeasy Positive PCR Positive Sensitivity Oropharyngeal
swab 124 145 85.52%
deep sputum 11 12 91.67%
Total 135 157 85.98%
(2) Specificity
Sample
2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test
Bioeasy Negative PCR Negative Specificity Oropharyngeal
swab 150 150 100%
deep sputum 13 13 100%
Total 163 163 100%
PRECAUTIONS
1.The reagent is a disposable diagnostic reagent in vitro, which is only used for the detection of human oropharyngea swab. The operation should be carried out strictly according to the instructions. Do not use expired and damaged products.
2.The kit should be sealed and kept away from moisture. Reagents or samples stored at low temperature should be balanced to room temperature before they can be used.
3.If clinical samples need to be frozen at -20°Cor below, it is recommended that the frozen storage time should not exceed three months and repeated freezing and thawing should not exceed three times.
4.Reagents should be used as soon as possible after removal from aluminium foil bags, so as to avoid exposure to air for too long and affecting test results due to dampness.
5.Do not use samples that have been placed for too long, bacteria and odor.
6.Please operate in accordance with the laboratory testing procedures for infectious diseases. Waste after use should be treated in accordance with infectious substances and should not be discarded at will.
7.Incorrect operation may affect the accuracy of the results, such as insufficient
sample mixing, wet display window or insufficient amount, inaccurate detection time, etc.
8.Components in different batch should not be mixed.
9.There should be appropriate biosafety assurance procedures for those substances containing and suspected sources of infection. The following are relevant considerations:
(1) Handle samples and reagents with gloves;
(2) Do not suck samples with your mouth;
(3) Do not smoke, eat, drink, cosmetic or handle contact lenses while handling these items;
(4) Disinfect the spilled sample or reagent with disinfectant;
(5) Disinfect and treat all samples, reagents and potential pollutants in accordance with relevant local regulations;
(6) Each component of the reagent remains stable until the expiry date under proper handling and storage conditions. Do not use the expired reagent kit.
Key to symbols used:
Materials Included ID Chip
Test Card with Desiccant in a Sealed
Foil Pouch Pipette Tip
Sample Diluent Instruction for Use
Consult Instructions
For Use Date of Manufacturer
Store at 2°C~30°C Do Not Reuse
Expiration Date Catalogue Number
Manufacturer Keep away from Sunlight
Lot Number Tests per Kit
Authorized
Representative Keep Dry
In Vitro Diagnostic
Medical Device The address of
manufacture factory Time-resolved Fluorescence Immunochromatographic Assay Subsidiary of Shenzhen Bioeasy Biotechnology Co., Ltd.
IFU VER: TS-IU-F027-A0 RELEASE DATE: 2020/01/28
Shenzhen Bioeasy Biotechnology Co., Ltd.
Add:No.11 R&D Center,Taohuayuan Science and Technology Innovation Park,Xixiang Sub-District,Baoan District,Shenzhen,Guangdong Province, China,518102
Tel: +86 755 2794 8546 Fax: +86 755 2794 8417 E-mail: info@bioeasy.com
No. 2-1 Liuxian 1st Road, Xin’an Sub-District, Baoan District, Shenzhen, Guangdong Province, China, 518101
kit e lettore per ricerca ANTIGENE – con metodica fluorimetrica cod. EASY
YRLF04401025
Novel Coronavirus (2020-nCoV Ag Fluorescence Rapid Test kits – 25 kits
Test rapido per la determinazione antigenica di SARS-CoV-2 - metodo fluorimetrico rapido – da tampone nasofaringeo / sputum
Risultati in 15 minuti
Il test è un valido supporto in tutte le occasioni in cui non sia disponibile la PCR RT, ma sia comunque necessario partire dal TAMPONE
cod. EASY YRLE01105
EASY-11 Fluorescence immunoassay analyzer (Lettore)
Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test 1 / 2
Cellex
Catalog Number：5513C
In Vitro Diagnostic
INTENDED USE
The Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test is a lateral flow immunoassay for the qualitative detection of 2019 novel coronavirus (SARS-CoV-2) in serum、
plasma or whole blood specimens. It is intended to be used as a screening test and aid in the diagnosis of SARS-CoV-2 viral infections. Any reactive specimen with the Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test must be confirmed with alternative testing method(s).
For in vitro diagnostic use only. For professional use only.
SUMMARY AND EXPLANATION OF THE TEST
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).
SARS-CoV-2 is a new strain that has not been previously identified in humans.
Coronaviruses are zoonotic, meaning they are transmitted between animals and people. Detailed investigations found that SARS-CoV was transmitted from civet cats to humans and MERS-CoV from dromedary camels to humans. Several known coronaviruses are circulating in animals that have not yet infected humans.
2019 Novel Coronavirus (SARS-CoV-2) is a virus (more specifically, a coronavirus) identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. Patients with SARS-CoV-2 have reportedly had mild to severe respiratory illness with symptoms of: fever, cough, shortness of breath. The rapid test has become an urgent need for screening patients.
The qSARS-CoV-2 IgG/IgM Rapid Test is intended to meet all requirements for yielding rapid, easily read, qualitative results for the main purpose of SARS-CoV-2 infection diagnosis.
TEST PRINCIPLE
The Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test is a lateral flow chromatographic immunoassay which can detect antibodies against the SARS-CoV-2 virus. The test cassette consists of: 1) a burgundy colored conjugate pad containing SARS-CoV-2 recombinant antigens conjugated with colloidal gold (SARS-CoV-2 conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing anti human IgG, M band is coated with anti human IgM, and the C band is pre-coated with goat anti rabbit IgG.
When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action along the cassette.
IgG anti-SARS-CoV-2 virus, if present in the specimen, will bind to the SARS-CoV-2 conjugates. The immunocomplex is then captured by the anti human IgG band, forming a burgundy colored G band, indicating a SARS-CoV-2 virus IgG positive test result suggesting a secondary CoV infection or previous CoV infection.
IgM anti-SARS-CoV-2 virus, if present in the specimen, will bind to the SARS-CoV-2 conjugates. The immunocomplex is then captured by the anti human IgM band, forming a burgundy colored M band, indicating a SARS-CoV-2 virus IgM positive test result suggesting a fresh primary infection.
If both G band and M band are visible, the test result suggests late primary or early secondary SARS-CoV-2 infection. Absence of both test bands (G and M) suggests a negative result.
The test contains an internal control (C band) which should exhibit a burgundy colored band of goat anti rabbit IgG/rabbit IgG-gold conjugate immunocomplex regardless of the color development on any of the test bands(G and M). Otherwise, the test result is invalid and the specimen must be retested with another device.
REAGENTS AND MATERIALS Reagents and Materials Provided
1. 25 test cassettes
2. 25 tubes (contain sample buffer) 3. 25 Capillary tubes
4. Leaflet with instruction for use
Composition and Concentration
Conjugate pad Monoclonal Anti-SARS-CoV-2 antigen conjugated on the membrane
G line Anti human IgG M line Anti human IgM C line Goat anti rabbit IgG Sample Buffer 0.01M PBS; PH 7.4 Material Required But Not Provided 1. Transfer Pipette Set 2. Timer
3. Specimen Collection Containers
WARNINGS AND PRECAUTIONS
1. This package insert must be read completely before performing the test.
Failure to follow the insert gives inaccurate test results.
2. Do not open the sealed pouch unless ready to conduct the assay.
3. Do not use expired devices.
4. Bring all reagents to room temperature (15℃-30℃) before use.
5. Do not use the components in any other type of test kit as a substitute for the components in this kit.
6. Wear protective clothing and disposable gloves while handling the kit reagents and clinical specimens. Wash hands thoroughly after performing the test.
7. Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.
8. Dispose of all specimens and materials used to perform the test as biohazardous waste.
9. Handle the Negative and Positive Control in the same manner as patient specimens.
10. The testing results should be read within 15 minutes after a specimen is applied to the sample well. Results read after 15 minutes may give erroneous results.
11. Do not perform the test in a room with strong air flow, i.e. an electric fan or strong air-conditioning.
STORAGE AND STABILITY
1. Store the detector buffer at 4-30℃. The buffer is stable up to 18 months.
2. Store Helios SARS-CoV-2 IgG/IgM Rapid Test Cassette at 4-30℃, shelf life is up to 18 months.
3. If stored at 2℃-8℃, ensure that the test device is brought to 15℃-30℃
before opening.
4. Do not freeze the kit or expose the kit over 30℃.
SPECIMEN COLLECTION AND PREPARATION
Consider any materials of human origin as infectious and handle them using standard biosafety procedures.
Plasma
1. Collect blood specimen into a lavender, blue or green top collection tube (containing EDTA, citrate or heparin, respectively in Vacutainer®) by venipuncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma into new pre-labeled tube.
Serum
1.Collect blood specimen into a red top collection tube (containing no anticoagulants in Vacutainer®) by venipuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum into a new pre-labeled tube.
Test specimens as soon as possible after collecting. If specimens are not tested immediately store at 2°C-8°C for up to 5 days. The specimens should be frozen at -20°C for longer storage.
Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.
Whole Blood
Drops of whole blood can be obtained by either finger tip puncture or venipuncture. Do not use any hemolyzed blood for testing.
Whole blood specimens should be stored in refrigeration (2℃-8℃) if not tested immediately. The specimens must be tested within 24 hours of collection.
TEST PROCEDURE
Step 1: Bring the specimen and test components to room temperature. Mix the specimen well prior to assay once thawed.
Step 2: When ready to test, open the pouch at the notch and remove device.
Place the test device on a clean, flat surface.
Step 3: Be sure to label the device with specimen’s ID number.
Step 4: Fill the capillary tube with the serum, plasma or whole blood not to exceed the specimen line as shown in the following image. The volume of the specimen is around 10μL. For better precision, transfer specimen by a pipette capable of delivering 10μL of volume.
Holding the capillary tube vertically, dispense the entire specimen into the center of the sample well (S well) making sure that there are no air bubbles.
Then add 2 drops (about 70-100 μL) of Sample Diluent immediately into the sample well (S well).
Step 5: Set up a timer.
Step 6: Read the result in 15 minutes.
Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test 2 / 2
Don’t read result after 15 minutes. To avoid confusion, discard the test device after interpreting the result
QUALITY CONTROL
1. Internal Control: This test contains a built-in control feature, the C line. The C line develops after adding specimen extract. If the C line does not develop, review the whole procedure and repeat test with a new device.
2. External Control: Good Laboratory Practice recommends using external controls, positive and negative, to assure the proper performance of the assay, particularly under the following circumstances:
A. New operator uses the kit, prior to performing testing of specimens.
B. A new lot of test kits is used.
C. A new shipment of kits is used.
D. The temperature used during storage of the kit falls outside of 2-30℃.
E. The temperature of the test area falls outside of 15 -30℃.
F. To verify a higher than expected frequency of positive or negative results.
G. To investigate the cause of repeated invalid results.
Index of CE Symbols
Consult instructions for use
For in vitro diagnostic use
only Use by
Catalog # Lot Number Tests per
kit Store between
2-30°C Authorized
Representative Do not
reuse
Manufacturer Date of
manufacture
Cellex, Inc. MedPath GmbH
76 TW Alexander Drive, Research Triangle Park, NC 27709-0002, USA Tel: 1-919-314-5535, Fax:1-919-314-5336, E-mail: info@cellex.us
Mies-van-der-Rohe-strasse 8, 80807 Munich, Germany
DR5513 Rev. A00 English version INTERPRETATION OF ASSAY RESULT
1. NEGATIVE RESULT: If only the C band is present, the absence of any burgundy color in the both test bands (G and M) indicates that no anti-SARS-CoV-2 virus antibodies are detected. The result is negative or non-reactive.
2. POSITIVE RESULT:
2.1 In addition to the presence of C band, if only G band is developed, the test result indicates for the presence of IgG anti- SARS-CoV-2 virus;
the result is IgG positive or reactive, suggesting late stage primary, early secondary or previous infection.
2.2 In addition to the presence of C band, if only M band is developed, the test indicates for the presence of IgM anti-SARS-CoV-2 virus. The result is IgM positive or reactive, suggesting fresh primary SARS-CoV-2 virus infection.
2.3 In addition to the presence of C band, both G and M bands are developed, the test indicates for the presence of IgG and IgM anti-SARS-CoV-2 virus. The result is IgG and IgM positive or reactive, suggesting current primary or early secondary SARS-CoV-2 virus infection.
Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a diagnostic determination is made.
3. INVALID: If the C line is not developed, the assay is invalid regardless of color development of the T band as indicated below. Repeat the assay with a new device.
LIMITATIONS OF THE PROCEDURE
1. The Assay Procedure and the Interpretation of Assay Result must be followed closely when testing for the presence of SARS-CoV-2 virus in the serum or plasma or whole blood specimen from individual subjects. For optimal test performance, proper sample collection is critical. Failure to follow the procedure may give inaccurate results.
2. The Cellex qSARS-CoV-2 Cassette Rapid Test is limited to the qualitative detection of SARS-CoV-2 virus. The intensity of the test band does not have linear correlation with virus titer in the specimen.
3. A negative or non-reactive result for an individual subject indicates absence of detectable SARS-CoV-2 virus. However, a negative or non-reactive result does not preclude the possibility of SARS-CoV-2 virus infection.
4. A negative or non-reactive result can occur if the quantity of the SARS-CoV-2 virus present in the specimen is below the detection limits of the assay, or if the virus that are detected are not present in the swab specimen sampled, or the viruses have undergone minor amino acid mutation in the epitope recognized by the antibody utilized in the test.
5. If symptoms persist, while the result from the Cellex qSARS-CoV-2 Cassette Rapid Test is negative or non-reactive, it is recommended to re-sample the patient a few days later or test with an alternative test device.
6. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.
