COVID-19 IgG/IgM Test Kit

Novel coronavirus COVID-19 IgG/IgM antibody detection kit (colloidal gold method)
(Whole blood/serum/plasma) product manual

A method for rapid detection of IgG and IgM antibodies to the novel coronavirus COVID-19 in human whole blood, serum or plasma samples. It is only for professional institutions and not for personal self-testing.
【product name】
Novel Coronavirus COVID-19 IgG/IgM Antibody Detection Kit
【Packing specifications】
25 copies/box, 40 copies/box
【expected usage】
The new coronavirus COVID-19 IgG/IgM antibody detection kit (whole blood/serum/plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies against COVID-19 in human whole blood, serum or plasma samples Analytical method.
【principle】
The new coronavirus COVID-19 IgG/IgM antibody test kit (whole blood/serum/plasma) is a qualitative detection method based on colloidal gold immunochromatography technology, which can be used to detect anti-COVID-19 in whole blood, serum or plasma samples IgG and IgM antibodies. This test consists of two parts, an IgG part and an IgM part. In the detection of IgG components, anti-human IgG antibodies are coated on the IgG test line. During the test, the sample reacted with the COVID-19 antigen-coated gold particles in the test box. If the specimen contains IgG antibodies against COVID-19, the mixture migrates upward on the membrane by capillary action and reacts with the anti-human IgG on the IgG detection line. A red line clearly visible to the naked eye will appear in the IgG test area. Similarly, anti-human IgM is coated in the IgM test area. If the sample contains anti-COVID-19 IgM antibodies, the antigen coating-sample complex reacts with anti-human IgM. As a result, a red line clearly visible to the naked eye appeared in the IgM test area.
If the sample contains COVID-19 IgG antibodies, a red line will appear in the IgG detection area. If the specimen contains COVID-19 IgM antibodies, a red line will appear in the area of ​​the IgM detection line. If the sample does not contain any kind of COVID-19 antibody, there will be no red line in any test area, indicating that the test result is negative. To ensure the effectiveness of the product, a red line will always appear in the quality control area of ​​the test kit, which indicates that the correct volume of sample has been added and chromatography has occurred.
【product composition】
The detection area of ​​the test card is coated with mouse anti-human IgG monoclonal antibody and mouse anti-human IgM monoclonal antibody. The sample reaction area contains COVID-19 antigen-coated particles, and the quality control area is coated with mouse anti-goat IgG monoclonal antibody.
【Precautions】
1. It is only used for professional in-vitro diagnosis, and it is prohibited to use after expiration.
2. Do not eat, drink or smoke in the area where the samples or products are processed.
3. If the outer packaging of the test box or the test card is damaged, do not use it.
4. All samples are processed according to the processing standards for samples containing infectious sources. All steps are carried out in accordance with established preventive measures against microbial hazards, and the samples and components of the finished product are properly handled in accordance with standard procedures.
5. When testing samples, be sure to wear protective clothing such as special laboratory clothing, with disposable gloves, disposable masks and goggles.
6. Make sure to drop samples of the correct volume for testing. Too much or too little sample size can lead to deviations in results.
7. The finished waste after use should be disposed of according to local regulations.
8. Temperature and humidity will adversely affect the test results.
【Storage and stability】
This kit should be sealed and stored at room temperature or 4-30℃. It can be stored stably under the sealed condition until the expiration date shown on the sealed part of the package. The product must be sealed and stored when not in use. The product cannot be frozen and cannot be used after the expiry date.
[Sample collection and preparation]
1. Whole blood (collected by venipuncture or fingertip puncture), serum or plasma can be used for COVID-19 IgG/IgM detection kits.
2. Collection of fingertip whole blood samples:
2.1. Wash the patient's hands with warm water and soap, then disinfect the hands with alcohol cotton balls and dry them.
2.2. Rub your hand in the direction of the fingertips of the middle finger or ring finger, and do not touch the puncture site.
2.3. Then pierce the skin with a sterile lancet to wipe off the initial bleeding.
2.4 Gently rub from the wrist to the palm to the finger direction until a little blood is produced at the beginning of the piercing, the end of the capillary
2.5 Touch the fingertip blood until it is filled with a volume of about 10μL to avoid air bubbles.
2.6 The fingertip whole blood collected from the capillaries is dripped into the test kit plus the sample to start the test.
3. Obtaining serum or plasma: After collecting whole blood, serum or plasma can be quickly separated to avoid hemolysis. This product is only used for the detection of non-hemolytic clear serum or plasma samples.
4. The blood sample should be tested immediately after collection. Do not leave the sample at room temperature for a long time. Serum and plasma samples can be stored at 2-8®C for 7 days. For long-term storage, serum/plasma samples should be stored in
-20®C. If the test is to be performed within 2 days after blood sample collection, whole blood should be collected by venipuncture and stored at 2-8®C. Do not freeze whole blood. Whole blood collected by fingertip puncture should be tested immediately.
5. Before testing, the sample to be tested must be placed at room temperature. Serum or plasma samples are completely thawed and thoroughly mixed before testing. Do not freeze and thaw repeatedly.
6. If the collected samples need to be transported, they should be packaged and transported in accordance with local regulations and standards related to pathogen transport.
7. EDTA K2, heparin sodium, sodium citrate and potassium oxalate can be used as anticoagulants for sample collection.
[Materials] Materials have been provided 1. Test card
2. Dropper
3. Buffer
4. Packing instructions
Materials needed but not provided 1. Sample collection container
2. Centrifuge (only for plasma)
3. Blood collection needle (only for fingertip whole blood)
4. Timer
【user's guidance】
Before the test, the test card, the sample to be tested, and the buffer solution need to be equilibrated to room temperature. The test should be performed at room temperature (15-30® C). Remove the test box from the aluminum foil bag. Use it within an hour. The best results will be obtained if the test is performed immediately after opening the aluminum foil bag.
Place the test box on a clean and level surface 1. Test serum or plasma samples:
(1) Use the dropper to add the sample: hold the dropper vertically, suck the sample to the filling line (about 10 ³´µL), and then transfer the sample to the sample hole (S). Then add 2 drops of buffer (about 70 ³´µL) and start the timer.
(2) Use a pipette to add sample: Use a pipette to transfer 10 ³´µL of sample to the sample hole (S), then add 2 drops of buffer (about 70 ³´µL), and start the timer
2. For venipuncture whole blood specimens:
(1) Use the dropper to add sample: hold the dropper vertically, draw the sample to about 1 cm above the filling line, and then transfer 1 drop of the complete sample (about 10μL) to the sample hole (S). Then add 2 drops of buffer (about 70 ³´µL) and start the timer
(2) Use a pipette to add sample: Use a pipette to transfer 10 ³´µL of whole blood to the sample well, then add 2 drops of buffer (about 70 ³´µL), and start the timer.
3. For fingertip whole blood specimens
(1) Use the dropper to add sample: hold the dropper vertically, draw the sample to about 1 cm above the filling line, and then transfer 1 drop of the complete sample (about 10μL) to the sample hole (S). Then add 2 drops of buffer (about 70 ³´µL) and start the timer.
(2) Use capillary to add sample: Use capillary to transfer about 10 ³´µL of fingertip whole blood sample to the sample hole (S) of the test box, then add 2 drops of buffer (about 70 ³´µL) and start the timer. See the figure below. Wait for the red line to appear. Read the results in 10-15 minutes. The interpretation is invalid after 20 minutes.
Note: It is recommended not to use the buffer six months after opening the bottle
[Explanation of test results]
1. IgG positive: Two red lines appear. A red line appears in the quality control line area (C), and a red line appears in the IgG line area. IgG positive
2. IgM positive: Two red lines appear. A red line appears in the quality control line area (C), and a red line appears in the IgM line area. Judged as IgM positive
3. Positive for IgG and IgM: Three colored lines appear. A red line appears in the quality control line area (C), and any shading in the IgG line area and IgM test line area should be considered positive.
4. Negative: A red line appears in the quality control line area (C). No lines appear in the IgG region and the IgM region.
Invalid: The quality control line is not out. Insufficient sample volume or incorrect sample dropping procedure is the most likely cause of quality control line failure. Review this step and repeat the test with a new test board. If the problem persists, please stop using the test kit immediately and contact your local dealer.
【Quality Control】
The inspection card contains a quality control area. A red line appears in the product's quality control line area (C), indicating that the sample amount is sufficient and the sample is added correctly. Although the product does not provide quality standards, the internal quality control process The positive and negative samples are fully tested in the laboratory to ensure that the operation is accurate and the performance verification is correct.
【limitation】
1. The new coronavirus COVID-19 IgG/IgM antibody detection kit (whole blood/serum/plasma) is only used for in vitro diagnosis. This test should be used to detect IgG and IgM antibodies against COVID-19 in whole blood, serum or serum samples. Neither the quantitative value nor the rate of increase of the IgG or IgM antibody concentration of COVID-19 can be determined by this qualitative test.
2. The new coronavirus COVID-19 IgG/Ig M antibody detection kit (whole blood/serum/plasma) test only shows the presence of anti-COVID-19 IgG and IgM antibodies in the sample, and cannot be used as the only criterion for the diagnosis of COVID-19 infection
3. As with all diagnostic tests, all results must be considered together with other reliable clinical information.
4. If the test result is negative and clinical symptoms persist, it is recommended to use other clinical methods for additional random testing. A negative result at any time does not rule out the possibility of contracting COVID-19.
5. The process and scope of the test must follow the principles of the use guide.
6. The test results of this reagent should be considered comprehensively in combination with clinical diagnosis, other laboratory tests and treatment responses.
7. The test results of this reagent are not applicable to the screening of donated blood.
【Performance Evaluation】
1. Sensitivity and specificity
Compare the test results of the new coronavirus COVID-19 IgG/IgM antibody test kit (whole blood/serum/plasma) with the results that have been tested by PCR; the results show that the new coronavirus COVID-19 IgG/IgM antibody test kit (Whole blood/serum/plasma) has high sensitivity and specificity.
IgG test results
Relative sensitivity: 96% (95%CI*: 86.3%-99.5%) *Confidence interval relative specificity: 100% (95%CI*: 94.2%-100%)
Accuracy: 98% (95%CI*: 92.9%-99.7%)
IgM test results
Relative sensitivity: 88.0% (95%CI*: 75.7%-95.5%) *Confidence interval
Relative specificity: 100% (95%CI*: 94.2%-100%)
Accuracy: 94% (95%CI*: 87.4%-97.8%)
2. Cross-reactivity
The new coronavirus COVID-19 IgG/IgM antibody test kit (whole blood/serum/plasma) has been tested for anti-influenza A virus, anti-influenza virus, anti-RSV, anti-Helicobacter pylori, anti-HIV and anti-HCV positive specimens. The results show no cross-reaction
3. Interference
The following compounds have been tested with the new coronavirus COVID-19 IgG/IgM antibody detection kit (whole blood/serum/plasma), and there is no interference.
Triglycerides: 50 mg/dL Ascorbic acid and Vitamin C: 20 mg/dL
Heme: 1000mg/dL Bilirubin: 60mg/dL Total cholesterol: 6mmol/L
[Approval date and revision date of the instruction manual] Approval date: 2020.5.16
Revision date: None
Issue Date: 2020.5.16
[Symbol Index]
See instructions for use
To
Store at 4-30®C
To
Expiration date

For in vitro diagnostic use only
To
Not reusable
To
batch number
To
manufacturer
To
Quantity
REF
Catalog number
To
EU representative
To
Moisture proof
To
Production Date

Biosecurity
To
CE registered

Wenzhou Ostar Biotech Co., Ltd.
Address: No. 38 Dongfang Road, Ouhai, Wenzhou (Room 1208, Building 1, University Science Park Incubator)
Phone: +8613868129154
Email: *