2019-NCoV Ag Rapid Saliva / Sputum Test Usage Manual Interpretation Test Card
Brand Name:ZOSBIO
Certification:CE BfArm
Model Number:2019-nCoV Ag Saliva/Sputum
Minimum Order Quantity:To be negotiated
Delivery Time:To be negotiated
Place of Origin:China
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Location:
Zhengzhou Henan China
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Office Address: Building 4, No. 51 Jingbei 3rd Road, Jingkai Zone, Zhengzhou City. Henan Province,China.
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Product Details
2019-NCoV Ag Rapid Saliva / Sputum Test Usage Manual Interpretation Test Card
Intended Use
This kit was used for the qualitative detection of the novel
coronavirus antigen in 2019.Was collected from human saliva /
sputum samples.
Novel coronavirus is a novel coronavirus that can cause viral
pneumonia.The clinical manifestations are fever, fatigue, dry
cough, and a few patients have nasal congestion, runny nose, sore
throat, diarrhea and other symptoms.Severe patients usually develop
dyspnea and / or hypoxemia just a week later, and severe patients
rapidly develop acute respiratory distress syndrome, infectious
shock, metabolic acidosis, and coagulopathy.
Novel coronavirus antigen legalization was detected in saliva /
sputum samples from suspected patients by using a side-flow
immunoassay.Antigens are usually detected in saliva / sputum
samples in the acute phase of the infection.Positive results
indicate the presence of viral antigens, but the clinical
correlation between patient history and other diagnostic
information is also necessary to determine the infection
status.Positive results do not exclude bacterial infections or
infections associated with other viruses.The detected pathogen may
not be the exact cause of the infection.Negative disease results
cannot exclude a novel coronavirus infection in 2019, and should
not be used as a basis for treatment or patient management
decisions (including infection control decisions).If the result is
negative, the final decision should be made based on the patient's
recent contact history, medical history, and any clinical signs and
symptoms consistent with the novel coronavirus, and confirmed by
nucleic acid analysis if necessary.
Principle of Detection
This kit is an immunoassay kit based on the principle of the
double-antibody sandwich technique.As an indicator, the labeled
2019 ncov monoclonal antibody was sprayed on the binding pad.During
the assays, the 2019 ncov Ag in the sample formed an Ag-ab complex
with the labeled 2019 ncov monoclonal antibody.Compounds migrated
upwards on the membrane by a capillary effect until they were
prepackaged on the detection line and captured by another 2019 ncov
monoclonal antibody to form a sandwich complex.If 2019 ncov AG is
present in the sample, red T stripes in the window.Otherwise, this
is a negative result.The Control line (c) is used for program
control.If the tester performs correctly, the control line is
always displayed.
Main Components
The kit consisted of a test card, a sample buffer, and a swab.
Test card: composed of aluminum foil bag, desiccant, test paper and
plastic card.The paper consists of water absorbent paper,
nitrofiber membrane, sample pad, rubber pad and rubber sheet.Nitro
cotton membrane T-line (detection line) packaging for 2019-NCOV Ab,
and c-line (QC line) packaging for the goat anti-rat polyclonal
antibody, with a binding pad containing the 2019-NCOV Ab tag.
Sample buffer: phosphate, sodium azo, etc.
Storage Conditions and Validity
The temperature was temporarily maintained at 2 to 30 ° C for 18
months.
The aluminum foil bag is valid within 1 hour after opening.
Production batch number: see the label for details.
Validity period: see the label.
Sample Requirements
(1) Saliva sample collection: do not eat or drink chewing gum or
tobacco products within 30 minutes after collecting the saliva
samples.Place the tip of the tongue against the palate and collect
the saliva roots.A disposable sterile cotton swab was placed under
the tongue for at least 10 seconds, fully immersed in the saliva,
and rotated more than 5 times.(See Table 1)
Note: If the saliva samples have not been collected correctly.
Figure 1 Methodsfor saliva sample collection
Figure 2 Methods for sputum sample collection
(2) Sputum specimen collection: after rinsing with water, cough up
the sputum, put it into the specimen bag, and wipe the specimen
with a disposable sterile cotton swab.(See Figure 2)
(3) Sample treatment: The collected samples shall be treated with
the sample buffer provided in this kit (the samples not processed
immediately shall be stored in dry, sterile and sealed containers)
for inspection.2 to 8 degrees Celsius to 24 hours, longer than-70
degrees Celsius (but avoid repeated freeze and thaw).
Test Method
Read the instructions carefully before testing.All reagents were
placed back at room temperature and testing should be performed at
room temperature.
Example processing (see Figure 3).
(1) Insert the sample swab into the sample buffer and rotate the
sample about 10 times near the inner wall to dissolve the sample in
the solution as much as possible.
(2) Squeeze the tip of the swab along the inner wall to flow the
liquid into the tube, remove the swab and discard the swab.
(3) Cover it with water droplets.
Figure 3 Sample processing
Figure 4 Test procedure
2. Test process (see Figure 4).
(1) Remove the test card.
(2) Add the addition of 2 drops (approximately 80L) of the treated
sample extract to the sample hole of the test card to start the
timer.
(3) The card was read for 15 minutes at room temperature, and the
results were invalid after 20 minutes.
Interpretation of Test Results
Description of the test card (see Figure 5):1. Results: the quality control line (the C line) should be rechecked.
2. Negative results: quality control line (C line), red ribbon, and coloring.
3. Positive results: there are two red stripes in the test line (t line) and the quality control line (C line).
Figure 5 Interpretation of test results
Limitation of Test Method
1. This product is a qualitative test, only for auxiliary in vitro
diagnosis.
2. This product is suitable for saliva and sputum samples, and
other sample types may have inaccurate or invalid sample results.
3. If the patient does not have sputum samples, a nasopharyngeal
swab should be used for testing.
4. Ensure that an appropriate amount of samples is added for
testing.Too much or too many samples can lead to inaccurate
results.
5. The test results of this reagent are for clinical reference
only, and should not be used as the only basis for clinical
diagnosis and treatment.After a comprehensive evaluation of all
clinical and laboratory results, a final diagnosis of the disease
should be made.
Product Performance Indicators
1. Detection limit: The inactivated sars-cov-2 virus culture was
used in this study. The minimum detection limit was 6,102 tcid50 /
ml.
2. Use the company's standard materials for testing, and the test
results should meet the requirements of the company's standard
materials.
2.1 Qualification rate of positive control: enterprise positive
control p1-p5.
2.2 Pass rate of negative control: our company n1-n10 negative
control test is negative.
2.3 Detection limit: refer to L1-L3, L1 is negative, and L2 and L3
are positive.
2.4 Reproducibility: Both J1 and J2 were 10-fold positive.
3. Cross-reaction: The following microbes and viruses were injected
into the samples at the specified concentrations to assess their
potential interference with the 2019 Novel Coronavirus antigen
detection procedure.virus
4. Interference: To evaluate the potential interference of the 2019-nCoV Ag testing procedure, and add the following drugs according to the prescribed concentration.The results showed that the various drugs did not interfere with the detection results of the reagents.
5. Hook effect: No hook effect was observed in the 2019-NCOV
inactivated cultures at a high concentration range of 1.0106 TCID50
/ mL.
6. Clinical research: RT-PCR sputum reagent as the contrast reagent
to detect saliva and sputum samples respectively.For each sample
size (RT-PCR test), 120 positive and negative samples were selected
and given a second test using the XIUS reagent.The study results
are summarized as follows:
Precautions
1. This product is used for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Strictly follow the reagent instructions, and read the
instructions carefully before the experiment.
4. Avoid testing in harsh environmental conditions (including high
concentration of corrosive gases, such as 84 disinfectant, dust,
sodium hypochlorite, acid-alkali, or acetaldehyde, etc.).Laboratory
disinfection shall be carried out after the experiment.
Logo interpretation
| Do not re-use | Store at 2℃～30℃ | ||
| Consult instructions for use | In vitro diagnostic medical device | ||
| Batch code | Use-by date | ||
| Keep dry | Keep away from sunlight | ||
Authorized representative in the European Community | Manufacturer |
Basic Information
ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD
Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA
Tel:+86-371-55016575
Email:zosbio@zosbio.com
Web:www.zosbio.com
SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
Company profile
Zhongxiu Science And Technology Co.,Ltd., is a high-tech enterprise
engaged in the research and development, production and operation
of in vitro diagnostic products. The in vitro diagnostic products
developed by the company cover POCT series, microbial series,
biochemical series and immune series reagents and supporting
instruments.
The company has always adhered to the core concept of "fast and accurate, living up to life", committed to providing society with excellent products and services, and contributing to the cause of human health.
The company has always adhered to the core concept of "fast and accurate, living up to life", committed to providing society with excellent products and services, and contributing to the cause of human health.
2019-NCoV Ag Rapid Saliva / Sputum Test Usage Manual Interpretation Test Card
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