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Rapid Antigen and Antibody test kit covid 19
Manufacturer: Shenzhen Lvshiyuan Biotechnology Co., Ltd / Green Spring Brand
The time required: 15 -20 minutes
Detect the virus 3 days after the infection
Accuracy: High
Specificity: High
Cost Saving : Low cost

Intended use:
AIVD COVID-19(SARS-CoV-2) IgG/IgM Rapid Test is a single use, rapid device for qualitative detection of total antibodies against 2019 novel coronavirus (SARS-CoV-2) in human serum, plasma or whole blood specimens. The kit is intended for screening of patients suspected for infection with SARS-CoV-2, and as an aid in the diagnosis of the coronavirus disease 2019 (COVID-19).

Descriptionï¼?
Novel coronavirus pneumonia (NCP) or SARS-COV-2, that was officially named by the WHO as â??Corona virus disease 2019â?? (COVID-19), is a respiratory infection caused by a new virus that was first identified in late 2019.

IgM/IgG Rapid Kit can specifically detect IgM and IgG antibodies of COVID-19, covering the entire course of infection and recovery period of patients. This approach improves the overall diagnosis of COVID-19 in both acute and recovery phases of illness.

This kit utilizes the principle of colloidal gold immunochromatography to qualitatively detect the new coronavirus (COVID-19) IgG / IgM antibodies in human serum and plasma. Lateral flow immunochromatographic assay provides an easy workflow, short turnaround time, and rapid diagnosis of COVID-19 suspected patients.

This method does not require expensive medical instruments and consumables. Just take the specimen and add it to the sample well, and then add the required amount of a diluent. The IgG / IgM antibodies in the sample will interact with the colloidal gold-labeled COVID-19 recombinant antigen on the conjugate pad. Then the conjugate pad will release re-solubilized conjugate onto the nitrocellulose membrane. The nitrocellulose membrane (NC membrane) diffuses it forward.
As the sample moves along the device binding reagents situated on the nitrocellulose membrane bind to the target at the test line. If the sample contains a COVID-19 IgG antibodies, they will bind to the colloidal gold-labeled novel coronavirus recombinant antigen, diffuse forward, and then react with the anti-human IgG antibodies immobilized on the NC membrane detection line (T2 line). Similarly, if the specimen contains IgM antibodies to COVID-19, the antibodies will react with antigen-coated particles, the conjugate migrate laterally forward, and cause a colored line (T1 line). The darker the color of colloidal gold on the test line, the higher the concentration antibodies to COVID-19 in the sample.

Accuracy:ï¼?> 90%
Specificity: 97%


Basic Protocolï¼?
1. Remove the test specimen, required reagents from storage conditions, and equilibrate to room temperature.
2. Unpack the aluminum foil bag, place the test horizontally on the table and number it.
3. Add 10ul serum, plasma or whole blood sample to the sample well with a pipette or a dropper. Slowly add 2 drops of sample dilution (about 60uL) to the sample well.
4. Read the results within 10-15 minutes after adding the sample, and the results will be invalid after 30 minutes.

Description

This kit utilizes fluorescence quantitative probe-based PCR and guarantees a high specificity to ensure accurate one-step identification of ORF1ab and N genes of 2019-nCoV. The kit offers a highly sensitive test with a limit of detection as low as 500 copies/ml. The results are available within 1.5 hour.

Kit Contents (48 Tests /Kit)
Dual Enzyme solution A 50 µl
Dual Ncvo-O / N reaction solution A 1 ml
Dual Ncvo-O / N positive control A 200 µl
Dual Negative control A 200µl

Applicable equipment
ABI series, Bio-Rad, Roche series and other fluorescent real-time PCR instruments.

Specimens requirements
Specimen type: nasopharyngeal swab from suspected infection; virus cell culture fluid, etc.

Basic Protocol
1. Sample preparation.
Take the test sample and extract the RNA nucleic acid according to the instructions of the nucleic acid extraction kit. The nucleic acid extraction product should be stored at -20 C.
2. Reaction mixture preparation
According to the total number of test samples, the number of PCR reaction tubes needed is. N = number of samples + 1 negative control + 1 positive control.
The following protocol is recommended for a 20 µl reaction volume. If the volume of reaction changes, please adjust proportionally.

Components Volume
Dual Enzyme solution A 1 µl
Dual Ncvo-O / N reaction solution A 19µl
Final Volume: 20 µl

3. Sample adding.
Add 5 µl each of the extracted RNA, positive and of negative control to corresponding reaction tubes. After assembling all the components, cover the tube caps and gently mix the contents of the tube, mix well, and centrifuge briefly.

4. Perform quantitative PCR
Place the reaction tube inside a real-time PCR instrument.
Set the channel and sample information, reaction system volume 25 µl.
Select the following channels: FAM channel for nCOV-ORF1ab, VIC channel for nCOV-N.
Perform quantitative PCR using recommended cycling parameters settings:

Step Temperature Time Number of cycles Fluorescence Detector
1 50C 15 min 1 Off
2 95C 3 min 1 Off
3 95C 10sec 45 Off
60C 30 sec On
Result analysis:
1) Set the baseline: Generally, it is set to 6-15cycle for ABI 7500, 7700 and other instruments, 3-15cycle for PE5700, and 6-12cycle for MJ Research Option2. Under special circumstances, the baseline can be adjusted accordantly.
2) Set the threshold: The threshold line just exceeds the highest point of the negative control amplification curve (random noise line).

AIVD Biotechs COVID-19 Ag test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein (NP) antigen from SARS-CoV-2 in direct nasal swabs from individuals suspected of COVID-19.

Description
This kit utilizes the principle of latex bead immunochromatography to qualitatively detect the new coronavirus (COVID-19) Np antigen in human nasal swabs. Lateral flow immunochromatographic assay provides an easy workflow, short turnaround time, and rapid diagnosis of COVID-19 suspected patients.
The test contains latex bead conjugate pad and a membrane strip pre-coated with antibodies specific to SARS-CoV-2 antigen on the test lines (T). If SARS-CoV-2 antigen is present in the specimen, a visible band appears on the test lines (T) as antibody-antigen-antibody latex bead complex forms. The control line (C) is used for procedural control and should always appear if the test is performed correctly.
This method does not require expensive medical instruments and consumables. Just take the specimen and add it to the sample well. If sample contains the antigen, it will interact with the latex bead-labeled COVID-19 anti-SARS-COV-2 NP antibodies on the conjugate pad.

Required components
1. A foil pouch with a desiccant and a single-use test card, 1 piece
3. Sterile swab, 1 piece
3. Extraction buffer tube (1 ml), 1 tube.
4. Instructions for use, 1 piece.

Specimen requirements:
1. Nasopharyngeal swab specimen.
2.Specimen should be tested as soon as possible upon collection. If the sample has to be stored, store the swab sample at room temperature for up to 1 hour or 2~8â?? for up to 4 hours prior to testing.

Specimen preparation
1. Insert the extraction buffer tube into the tube rack, make sure that the sample tube is firmly upright and touches the bottom of the rack.
2. Insert the swab into an extraction buffer tube.
3. Gently stir the swab in the tube, and then left swab inside the tube for 1 minute or Mix on the vortex mixer for about 30 seconds,
4. The sample should be tested immediately after collection.
If it cannot be tested in time, it should be stored in the virus transport matrix. The specimens can be stored at 2-8C for 4 hours

Basic Protocol
Step 1: If the sample is refrigerated, remove the sample to be tested and the required reagents from the storage conditions, equilibrate to room temperature (15~30C)
Step 2: When preparing to test, open the aluminum foil bag, take out the test card, and lay it flat on a table.
Step 3: Mark the sample number on the test card,
Step 4: Using pipette add 50ul of the sample into a sample well on the device,
Step 5: Read the result within 15 minutes,
Please read the result after 15 minutes. After observing and recording the result, please discard the test card to avoid affecting the result judgment.
Do not read test results after 30 minutes. It may give false results.