[Product Name] IgG/IgM Antibody Rapid Test Kit ( Colloidal-Gold Immunochromatographic Assay)

[Package] 1 Test, 20 Tests

[Intended Use]This test kit is used to identify the antibodies against virus in human serum, plasma or whole blood of vein/fingertip samples in vitro. It is only used as a supplementary diagnostic for suspected cases which shows negative in nucleic acid test. It is used in conjunction with nucleic acid detection in diagnosis, and cannot be used as a basis for diagnosis and exclusion of pneumonia infection. It is not applicable to screening of general population.
Further confirmation is required if there is a positive test. The possibility of infection cannot be ruled out by a negative test result.
The product is limited to the emergency reserve for clinical use during the pneumonia outbreak, and cannot be used as a routine in vitro diagnostic reagent for clinical practice. The test results of this kit are only for clinical reference, and it is recommended to conduct a comprehensive analysis of the condition in combination with patient's clinical manifestations and other laboratory tests.
The laboratory test should be carried out in accordance with the requirements of Technical Guidelines for Laboratory Test of Pneumonia. Measures to ensure biosafety shall be taken.

Note: the components in kits with different batch number should not be mixed for fear that the results might be wrong.

[Storage and Handling] Store at room temperature or 2˚C~30˚C. The expiry period is 6 months.
The Test Cassette should be used within 1 hour after the aluminum foil bag is opened. The Assay diluents should be capped immediately after opening and placed in cool place. Please use it within the expiry period.
Manufacturing date: see the product label
Expiry date: see the product label

[Sample Requirements]
serum/ plasma/ Venous whole blood/ Fingertip blood.Collection of serum/plasma samples: The serum and plasma should be separated as soon as possible after blood collection, and the test should be conducted within 8 hours. If not detected in time, it should be kept at 2°C ~8°C for 3 days or refrigerated at -20°C for 9 days. Please equilibrate to room temperature before testing and avoid repeated freezing and thawing. Severe hemolytic or thermal-inactivated samples are not recommended.Venous whole blood collection: use anticoagulation tube or add anticoagulant (heparin, EDTA salt, sodium citrate) in blood collection tube to collect blood, shake well. It can be stored for 8 hours at room temperature. If it cannot be detected immediately, it can be stored at 2˚C ~ 8˚C for 7 days. Whole blood samples stored for more than 7 days are not suitable for this test.Fingertip blood collection: wash hands with warm water or rub the fingertips to improve the blood circulation before blood collection. Wipe the left ring fingertip (middle finger of children) of the testee with alcohol wipes. Then, prick the fingertip with the blood needle to form blood drop after the alcohol is dried. Drop two drops of blood into the sampling hole.

[Test Procedure]Please read the instruction manual carefully before testing. The samples to be tested, detection reagents and other materials used for testing need to be equilibrated to room temperature. The test should be performed at room temperature.
Open the aluminum foil bag along the tear, take out the Test Cassette and lay it flat.Add 20 µL of venous whole blood samples or 10 µL of serum or 10 µL of plasma or two drops of fingertip blood samples to the wells of the Test Cassette, and then add approximate 50 µL of the Assay diluents (about 2 drops) to the wells.Observe the results after 10 minutes, and the results displayed after 15 minutes have no clinical significance.
[Interpretation of Results]Invalid: the test is invalid when there is no red line in the quality control area (C). It is recommended to retest with a new test card, and pay especial attention to whether the sample amount is sufficient;
Positive: two red lines, one appears in the detection area (G) or in the detection area (M), and one in the quality control area (C); three red lines, a red reaction line appears in the detection area (G), the detection area (M) and the quality control area (C) respectively.
Negative: one red line, that is, only a red reaction line appears in the quality control area (C).

 [Limitations]
This reagent is only used for the detection of human serum, plasma, vein/fingertip blood samples.The accuracy of the test depends on the sample collection process. Improper sample collection, storage or repeated freezing and thawing of samples will affect the test results.Virus antibody in human blood serum, plasma and vein/fingertip blood samples can only be detected qualitatively by this kit. The content of antibody in samples cannot be accurately determined.Limited by the methodology of antibody detection reagents, the detection results are only for clinical reference, and shall not be the only basis for clinical diagnosis and treatment. The clinical management of patients should be considered comprehensively in combination with their symptoms, signs, epidemic history, other laboratory tests and treatment reactions.Analysis of the possibility of false negative results:
improper collection, transport and treatment of samples and low virus titer in samples may lead to false negative results.the variation of virus gene may lead to the change of antibody determinants, which may lead to false negative results.

[Performance]
1.    Coincidence rate of positive reference
test the IgG/IgM antibody test paper with positive reference P1-P2, the results in IgM lines should all be positive and the coincidence rate is 100%. test the IgG/IgM antibody test paper with positive reference P3-P5, the results in IgG lines should all be positive and the coincidence rate is 100%.
2.    Coincidence rate of negative reference
test the IgG/IgM antibody test paper with negative reference N1-N10, the results in IgM lines should all be negative and the coincidence rate is 100%. test the IgG/IgM antibody test paper with negative reference N1-N10, the results in IgG lines should all be negative and the coincidence rate is 100%.
3.    Limit of detection:
Test the IgG/IgM antibody test paper with the dilution LOD reference product S1. The result of S1 IgM line should be positive while that of S1 1/2 is negative or positive.Test the IgG/IgM antibody test paper with the dilution LOD reference product S2. The result of S2 IgG line should be positive while that of S2 1/2 is negative or positive.
4.    Repeatability:
Test 10 of the IgG/IgM antibody test paper with repeatability reference CV1. The results of IgM line should be all positive with uniform color.Test 10 of the IgG/IgM antibody test paper with repeatability reference CV2. The results of IgG line should be all positive with uniform color.
5.  Specificity: no cross reactivity with antibody of other pathogen in the serum or plasma collected from clinical samples.
6.  Hook effect: within the titer range of a clinically positive sample of novel coronavirus antibody, there is no hook effect in the results of this test.

[Notice]
1. This product is a single-used in vitro diagnostic reagent. Do not reuse it. Do not use it if it is expired.
2.   The high temperature of the experimental environment shall be avoided. To avoid moisture absorption, the Test Cassette and the Assay diluents stored at low temperature shall be opened after the equilibrated to room temperature.
3.    After test, the used  Test Cassette and Assay diluents droplet bottle should be treated as biomedical waste.
4.    The desiccant is contained in the foil composite packaging bag, which should not be taken orally.
5.    Do not use repeated freeze-thaw samples. please equilibrate the samples to room temperature when testing.
6.    The test samples shall be regarded as infectious products. The operation shall be in accordance with the Operation Procedure of Infectious Diseases Laboratory, and pay attention to the biological safety.
7.    As with all diagnostic reagents, the final diagnosis should be decided by the doctor after combining the various detection indicators and clinical symptoms.
8.   If there is any question or suggestion during the use of this test, please contact the manufacturer.

[Information]
Registrant / Manufacturer Name: Jiangsu Simcere Medical Device Co., Ltd.Address: Building 28,No.699-18,Xuanwu Avenue, Xuanwu District, Nanjing City,Jiangsu,China
 
Name of after-sales service unit: Jiangsu Simcere Medical Device Co., Ltd.
 
Production address: Building 7,No.699-18,Xuanwu Avenue, Xuanwu District, Nanjing City,Jiangsu,China
[Approval date and modification date of the manual] May 29th, 2020