Sungo global services HRK-6620 SARS-CoV-2 Antigen Rapid Test Kit User Manual
- June 5, 2024
- Sungo global services
Table of Contents
Sungo global services HRK-6620 SARS-CoV-2 Antigen Rapid Test Kit
SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) Package Insert
REF: HRK-6620
The SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) Rapid Test is for
the rapid, qualitative detection of the nucleocapsid protein antigen from
SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab
specimen. The test is for in vitro diagnostic use only. For professional use
only. II is intended for clinical laboratories and healthcare professional use
only for point-of-care testing. Not for
at-home testing.
INTENDED USE
SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) is an in vitro diagnostic test for the qualitative detection of SARS-CoV-2 antigens in Nasal swab and Nasopharyngeal swab and Oropharyngeal swab, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the SARS-CoV-2 antigen. It will provide information for clinical doctors to prescribe correct medications.
SUMMARY
COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the SARS-CoV-2 are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
PRINCIPLE
SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) is an
immunochromatographic membrane assay that uses highly sensitive monoclonal
antibodies to SARS-CoV-2.
The test device is composed of the following three parts, namely sample pad,
reagent pad and reaction membrane. The whole strip is fixed inside a plastic
device. The reagent membrane contains the colloidal-gold conjugated with the
monoclonal antibodies against SARS-CoV-2; the reaction membrane contains the
secondary antibodies for SARS-CoV-2, and the polyclonal antibodies against the
mouse globulin, which are pre-immobilized on the membrane.
When the sample is added into the sample window, conjugates dried in the
reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 is
present in the sample, a complex formed between the anti-SARS-CoV-2 conjugate
and the virus will be caught by the specific anti-SARS-CoV-2 monoclonal coated
on the T region.
Whether the sample contains the virus or not, the solution continues to
migrate to encounter another reagent (an anti-mouse IgG antibody) that binds
the remaining conjugates, thereby producing a red line on the region C.
SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) product can detect
SARS-Cov-2 nucleo-protein (mainly) and spike protein.
More than 90% of the antibody used in the SARS-CoV-2 Antigen Rapid Test Kit
(Immunochromatography) is anti-nucleoprotein of SARS-Cov-2 and the target
protein is the SARS-Cov-2 nucleoprotein.
The rest of the antibody used in SARS-CoV-2 Antigen Rapid Test Kit
(Immunochromatography) is anti-Spike protein and target protein is SARS-Cov-2
Constant fragment of Spike protein.
At present, whether the N501Y in the United Kingdom or the 501Y.V2 in South
Africa, the variant fragments are mainly from the RBD fragment of the S
protein, and the target fragments of the antibodies used in SARS-CoV-2 Antigen
Rapid Test Kit (Immunochromatography) have not been mutated. So, SARS-CoV-2
Antigen Rapid Test Kit (Immunochromatography) can reliably detect the SARS-
Cov-2 variants.
REAGENTS
The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against SARS-CoV-2; the reaction membrane contains the secondary antibodies for SARS-CoV-2, and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane.
PRECAUTIONS
- For in vitro only.
- For professional use only.
- Do not use after the expiration date.
- Ensure foil pouch containing test device is not damaged before opening for use.
- Perform test at room temperature 15 to 30°C.
- Wear gloves when hanging the samples, avoid touching the reagent membrane and sample window.
- All samples and used accessories should be treated as infectious and discarded according to local regulations.
- Avoid using bloody samples.
STORAGE AND STABILITY
Store SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) at room temperature or refrigerated (2-30°C). Do not freeze. All reagents are stable until the expiration dates marked on their outer packaging and buffer vial.
SPECIMEN COLLECTION AND HANDLING
-
Specimen collection
-
Nasal swab specimen (recommended)
It is important to obtain as much secretion as possible. Insert the sterile swab into one nostril. 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. Repeat this process for the other nostril to ensure that an adequate specimen is collected from both nasal cavities (use the same swab). -
Oropharyngeal swab specimen (optional)
It is important to obtain as much secretion as possible. Insert the sterile swab into throat that presents the most secretion from the red area of the throat wall and maxillary tonsils to collect throat swab specimen. Rub the bilateral throat tonsils and throat wall moderately to obtain the specimen. Please do not touch the tongue when remove the swab. -
Nasopharyngeal swab specimen (optional)
It is important to obtain as much secretion as possible. Insert the sterile swab into the nostril that presents the most secretion under visual inspection. Keep the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab 5 times then remove it from the nasopharynx.
-
-
Specimen handling
Freshly collected specimens should be tested as soon as possible. It is essential that correct specimen collection and preparation methods are followed.
MATERIALS
Materials provided
- 20*Test Cassette
- 1*Package Insert
- Tube Stand*
- 20*Sterilized Swab
- 20*Nozzle
- 20*Extraction Tube
- 20*Sample Extraction Buffer
The 20-test package contains the tube stand the 5-test and 1-test package use the test box itself as tube stand.
DIRECTIONS FOR USE
Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C) prior to testing.
-
Hold the sealed pouch vertically and let all extraction solution flow into the bulb. Break the tip and squeeze the bulb to dispense all extraction solution into the extraction tube.
-
Collect specimen refer to Specimen Collection.
-
Insert the swab with collected specimen into the extraction tube filled with extraction solution. Roll the swab 5 times while pressing the head against the bottom and side of the extraction tube. Remove the swab while squeezing the sides of the lube to extract the liquid from the swab. Try to release as much liquid as possible. Dispose the used swab as a biohazard waste.
-
Put on the tube tip.
-
Take out a test device from sealed foil pouch and put it on a clean and level surface.
-
Apply 3 drops (about 60 µL) of the extracted specimen into the specimen well. Please avoid bubbles during applying.
-
Add 3 drops of the solution (approx.80ul) to the sample well and then start the timer. Read the result at 10~20 minutes. Don’t interpret the result after 20 minutes.
Note:
- Do not interchange or mix extraction solution from different lots.
- Handle extraction solution with caution, do not contact with eyes or skjn. If spilled on eyes or skin, wash thoroughly with water.
- Please follow local regulations to handle the used materials.
INTERPRETATION OF RESULTS
-
Positive Result:
Both the quality control line C and the detection line T appear. -
Negative Result:
Only the quality control line C appears, with no other line appearing on the detection line. -
Invalid Result:
Quality control line C fails to appear indicating the test is invalid, no matter if the detection line appears or not. Collect a new specimen and perform another test with a new test device.
QUALITY CONTROL
Internal procedural controls are included in the test. A colored line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. 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
- SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) is an acute-phase screening test for qualitative detection. Sample collected may contain antigen concentration below the reagent’s sensitivity threshold, so a negative test result does not exclude infection with SARS-CoV-2
- SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) detects viable and non-viable SARS-CoV-2 antigen. Test performance depends on antigen load in the sample and may not correlate with cell culture performed on the same sample. A positive test does not rule out the possibility that other pathogens may be present, therefore, the results must be compared with all other available clinical and laboratory information to make an accurate diagnosis.
- A negative test result may occur if the level of extracted antigen in a specimen is below the sensitivity of the test or if poor quality specimen is obtained
- Performance of the test has not been established for monitoring antiviral treatment of SARS-CoV-2.
- Positive test results do not rule out co-infections with other pathogens.
- Negative test results are not intended to rule in other coronavirus infection except the SARS-Cov-2.
- Children tend to shed virus for longer periods of time than adults, which may result in differences in sensitivity between adults and children List.
- A negative result may occur if the concentration of antigen in a specimen is below the detection limit of the test or if the specimen was collected or transported improperly, therefore a negative test result does not eliminate the possibility of SARS-Cov-2 infection and should be confirmed by viral culture or PCR.
PERFORMANCE CHARACTERISTICS
Clinical Evaluation
Clinical evaluation was performed to compare the results obtained by SARS-
CoV-2 Antigen
Rapid Test Kit (Immunochromatography) and PCR. The results were summarized
below:
Table: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) vs. PCR
Method| SARS-CoV-2 Nucleic Acid Test Kit (RT-PCR)|
Total Results
---|---|---
SARS-CoV-2 Antigen Rapid Test Kit
(Immunochromatography)
| Results| Positive| Negative
Positive| 98| 0| 100
Negative| 2| 210| 210
Total Results| 100| 210| 310
Clinical sensitivity =2 /100=98.00 % (95%CI 97.12% to 99.98%)
Clinical specificity = 210/210=100.00% (95%CI 98.12% to 99.99%)
Accuracy: (98+210)/ (98+2+0+210) 100%=99.35% (95%CI 98.78% to 99.89%)
Confidence Interval
Limit of Detection (LoD)
| SARS-CoV-2 Strain Tested | Huaree Tech product |
|---|---|
| Stock SARS-CoV-2 Concentration | 1 X 106 TCID50/mL |
| Dilution | 1/100 |
| Concentration in Dilution tested (TCID50/ml) | 1X104 |
| 1.25X103 | 6.25X102 |
| Call rates of 20 replicates near cut-off | 100(20/20) |
| 95(19/20) | 10(2/20) |
| Limit of detection (LoD) per Virus Strain | 1.25 X 103 TCID50/mL |
CROSS-REACTIVITY
The test results are below the corresponding concentration of the substances in the table below, which has no effect on the negative and positive test results of this reagent, and there is no cross-reaction.
| Virus/Bacteria/Parasite | Strain | Concentration |
|---|---|---|
| MERS-coronavirus | N/A | 72 μg/mL |
Adenovirus
| Type 1| 1.5 x 106TCID50/mL
Type 3| 7.5 x 106TCID50/mL
Type 5| 4.5 x 106TCID50/mL
Type 7| 1.0 x 106TCID50/mL
Type 8| 1.0 x 106TCID50/mL
Type 11| 2.5 x 106TCID50/mL
Type 18| 2.5 x 106TCID50/mL
Type 23| 6.0 x 106TCID50/mL
Type 55| 1.5 x 106TCID50/mL
Influenza A
| H1N1 Denver| 3.0 x 108TCID50/mL
H1N1 WS/33| 2.0 x 108TCID50/mL
H1N1 A/Mal/302/54| 1.5 x 108TCID50/mL
H1N1 New Caledonia| 7.6 x 108TCID50/mL
| H3N2 A/Hong Kong/8/68| 4.6 x 108TCID50/mL
---|---|---
Influenza B
| Nevada/03/2011| 1.5 x 108TCID50/mL
B/Lee/40| 8.5 x 108TCID50/mL
B/Taiwan/2/62| 4.0 x 108TCID50/mL
Respiratory syncytial virus| N/A| 2.5 x 106TCID50/mL
Legionella pneumophila
| Bloomington-2| 1 x 105 PFU/mL
Los Angeles-1| 1 x 105 PFU/mL
82A3105| 1 x 105 PFU/mL
Rhinovirus A16| N/A| 1.5 x 106TCID50/mL
Mycobacterium tuberculosis
| K| 1 x 105PFU/mL
Erdman| 1 x 105PFU/mL
HN878| 1 x 105PFU/mL
CDC1551| 1 x 105PFU/mL
H37Rv| 1 x 105PFU/mL
Streptococcus pneumonia
| 4752-98 [Maryland (D1)6B-17]| 1 x 105PFU/mL
178 [Poland 23F-16]| 1 x 105PFU/mL
262 [CIP 104340]| 1 x 105PFU/mL
Slovakia 14-10 [29055]| 1 x 105PFU/mL
Streptococcus pyrogens| Typing strain T1 [NCIB 11841, SF 130]| 1 x 105PFU/ml
Mycoplasma pneumoniae
| Mutant 22| 1 x 105PFU/ml
FHstrainofEatonAgent [NCTC 10119]| 1 x 105PFU/ml
36M129-B7| 1 x 105PFU/ml
Coronavirus
| 229E| 1.5 x106TCID50/ml
OC43| 1.5 x106TCID50/ml
NL63| 1.5 x 106TCID50/ml
HKU1| 1.5 x 106TCID50/ml
Human etapneumovirus (hMPV) 3 Type B1| Peru2-2002| 1.5 x 106TCID50/ml
Human Metapneumovirus (hMPV) 16 Type A1| IA10-2003| 1.5 x 106TCID50/ml
Parainfluenza virus
| Type 1| 1.5 x 106TCID50/ml
Type 2| 1.5 x 106TCID50/ml
Type 3| 1.5 x 106TCID50/ml
Type 4A| 1.5 x 106TCID50/ml
Interfering Substances Reaction
When tested using the SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography), there was no interference between the device reagents and the Potential interference substances listed in below table that would create false positive or negative results for SARS-Cov-2 antigen.
| Substance | Concentration | Substance | Concentration |
|---|---|---|---|
| Mucin | 100μg/mL | Acetylsalicylic acid | 3.0 mM |
| Whole Blood | 5% (v/v) | Ibuprofen | 2.5 mM |
| Biotin | 100μg/mL | Mupirocin | 10 mg/mL |
| Neo-Synephrine (Phenylephrine) | 5%(v/v) | Tobramycin | 10μg/mL |
| Afrin Nasal Spray (Oxymetazoline) | 5%(v/v) | Erythromycin | 50uM |
| Saline Nasal Spray | 5%(v/v) | Ciprofloxacin | 50uM |
| Homeopathic | 5%(v/v) | Ceftriaxone | 110mg/mL |
| Sodium Cromoglycate | 10 mg/mL | Meropenem | 3.7μg/mL |
| Olopatadine Hydrochloride | 10 mg/mL | Tobramycin | 100μg/mL |
| Zanamivir | 5 mg/mL | Histamine Hydrochloride | 100μg/mL |
| Oseltamivir | 10 mg/mL | Peramivir | 1mmol/mL |
| Artemether-lumefantrine | 50uM | Flunisolide | 100μg/mL |
| Doxycycline hyclate | 50uM | Budesonide | 0.64nmol/ L |
| Quinine | 150uM | Fluticasone | 0.3ng/mL |
| Lamivudine | 1 mg/mL | Lopinavir | 6μg/mL |
| Ribavirin | 1 mg/mL | Ritonavir | 8.2mg/mL |
| Daclatasvir | 1 mg/mL | Abidor | 417.8ng/mL |
| Acetaminophen | 150uM | Pooled human nasal wash | N/A |
SYMBOLS
| Symbol | Meaning | Symbol | Meaning |
|---|---|---|---|
| In vitro diagnostic medical device | Storage temperature limit | ||
Manufacturer
| | Authorized representative in the European Community
| Date of Manufacture| | Use by date
| Do not reuse| | Consult instruction foe use
---|---|---|---
| Batch code| | Meet the requirements of EC Directive 98/79/EC
SHENZHEN HUAREE TECHNOLOFY CO,LTD
3th Building, Huahang Technology Industrial Park,
No.19 Lanjin 4th road, Heping Community, Pingshan
District, Shenzhen 518118, China
Website: www.huareetech.com
Email：info@huareetech
SUNGO Europe B.V.
Olympisch Stadion 24,1076DE
Amsterdam, Netherlands
Email：ec.rep@sungogroup.com
Tel：+31(0)2021 11106
Number: 6600210322
Version: 2.0
Effective Date: 2021-03-22
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