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Brand Name : | ZOSBIO |
Model Number : | 2019-nCoV Ag Saliva/Sputum |
Certification : | CE BfArm |
Price : | To be negotiated |
Supply Ability : | 10000 Kit/Kit per Day |
Delivery Time : | To be negotiated |
This kit is used for qualitative detection of novel coronavirus
antigen in 2019. Collect human saliva/sputum samples.
Novel coronavirus is a kind of novel coronavirus which can cause
viral pneumonia. The clinical manifestations are fever, fatigue and
dry cough, and a few patients have symptoms such as nasal
congestion, runny nose, sore throat and diarrhea. Severe patients
usually suffer from dyspnea and/or hypoxemia after one week, and
severe patients rapidly suffer from acute respiratory distress
syndrome, septic shock, metabolic acidosis and coagulation
dysfunction.
The legitimacy of novel coronavirus antigen in suspected
saliva/sputum samples was detected by lateral flow immunoassay.
Antigen is usually detected in saliva/sputum samples at the acute
stage of infection. The positive results indicate the presence of
viral antigen, but the clinical correlation between medical history
and other diagnostic information is also necessary to determine the
infection status. Positive results do not exclude bacterial
infections or infections related to other viruses. The detected
pathogen may not be the exact cause of infection. The negative
results of 2019 coronavirus disease do not exclude 2019, and should
not be used as the basis of treatment or patient management
decisions (including infection control decisions). If the result is
negative, it should be confirmed by nucleic acid analysis based on
the patient's recent exposure history, past medical history,
clinical symptoms and symptoms related to novel coronavirus.
The kit consists of test card, sample buffer and cotton swab.
Test card: It consists of aluminum foil bag, desiccant, test strip
and plastic card. The paper consists of absorbent paper,
nitrocellulose membrane, sample pad, rubber pad and rubber sheet.
2019 nitrocellulose membrane T-line (detection line) is wrapped in
ncov Ab, C-line (QC line) is wrapped in goat anti-mouse polyclonal
antibody, and the binding pad contains 2019 ncov Ab label.
Sample buffer: phosphate, sodium azo, etc.
(1) Saliva sample collection: Do not eat or drink chewing gum or
tobacco products within 30 minutes after saliva sample collection.
Place the tip of the tongue on the palate to collect saliva roots.
Disposable sterile cotton swabs are placed under saliva samples.
Use the tip of the tongue for at least 10 seconds, completely
immerse in saliva and rotate for more than 5 times. (see table 1)
Note: If the saliva sample is not collected correctly.
Figure 1 Methodsfor saliva sample collection
Figure 2 Methods for sputum sample collection
(2) Sputum specimen collection: rinse with water, cough up sputum,
put it into specimen bag, and wipe the specimen with disposable
sterile cotton swabs. (see figure 2)
(3) Sample treatment: use the sample buffer provided in this kit to
treat the collected samples (samples that are not immediately
treated should be stored in dry, sterile and sealed containers).
2-8 degrees Celsius to 24 hours, more than 70 degrees Celsius (but
avoid repeated freezing and thawing).
Please read the instruction carefully before testing. Return all
reagents to room temperature and test at room temperature.
Example processing (see Figure 3).
(1) Insert the sample swab into the sample buffer, rotate the
sample near the inner wall for about 10 times, and dissolve the
sample in the solution as much as possible.
(2) Press the swab head along the inner wall to make the liquid
flow into the pipeline, take out the swab and discard it.
(3) Cover with small water droplets.
Figure 3 Sample processing
Figure 4 Test procedure
2. Test process (see Figure 4).
(1) take out the test card.
(2) Add 2 drops (~80L) of processed sample extract to the sample
well of the test card, and start timing.
(3) Read the card at room temperature for 15 minutes, and the
result is invalid after 20 minutes.
Figure 5 Interpretation of test results
1. This product is a qualitative test, which is only used to assist
in vitro diagnosis.
2. This product is suitable for saliva and sputum samples, and
other types of samples may have inaccurate or invalid sample
results.
3. If the patient has no sputum samples, nasopharyngeal swabs
should be used for detection.
4. Make sure to add the right amount of samples for testing. Or too
many samples may 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. Comprehensive evaluation of all clinical
and laboratory results will finally confirm the disease.
1. detection limit: inactivated SARS-COV-2 virus culture was used
in this study. The lowest detection limit is 6102 tcid50/ml.
2. The test adopts company standard materials, and the test results
should meet the requirements of company standard materials.
2.1 active control pass rate: enterprises actively control p1-p5.
2.2 Negative control pass rate: Our n1-n10 negative control test
was negative.
2.3 detection limit: refer to L1-L3, L1 is negative, L2 and L3 are
positive.
2.4 Reproducibility: J1 and J2 are 10 times positive.
3 Cross-reaction: Inject the following microorganisms and viruses
into specific concentration samples to evaluate their potential
interference with the 2019 novel coronavirus antigen detection
procedures.
4. Interference: Evaluate the potential interference in the 2019
nCoV Ag detection procedure, and add the following drugs at the
specified concentration. The results showed that all kinds of drugs
did not interfere with the detection results of reagents.
5. Hook effect: There is no hook effect in the high concentration
range of 1.0106 TCID50/mL.
6. Clinical study: Using RT-PCR sputum reagent as control reagent
to detect saliva and sputum samples respectively. For each sample
size (RT-PCR test), 120 positive and negative samples were
selected, and the second test was conducted with XIUS reagent. The
survey results are summarized as follows:
1. This product is used for in vitro diagnosis.
2. This product is disposable and cannot be recycled.
3. Please strictly abide by the reagent instructions, and please
read the instructions carefully before the experiment.
4. Avoid testing under harsh environmental conditions (including
high-concentration corrosive gases, such as 84 disinfectant, dust,
sodium hypochlorite, acid and alkali, acetaldehyde, etc.).
Laboratory disinfection should be carried out after the experiment.
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