Testsealabs Monkey Pox Antigen Test Cassette (Swab)
1.The Cassette is used for in vitro qualitative detection of suspected cases of Monkeypox Virus (MPV), clustered cases and other cases that need to be diagnosed for Monkeypox Virus infection.
2.The Cassette is a chromatographic immunoassay for the qualitative detection of Monkey Pox antigen in oropharyngeal swabs to aid in the diagnosis of Monkey Pox virus infection.
3.The test results of this Cassette are for clinical reference only and should not be used as the sole criterion for clinical diagnosis. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests.
INTRODUCTION
| Assay type | Oropharyngeal swabs |
| Test type | Qualitative |
| Test material | Prepackaged extraction bufferSterile swab Workstation |
| Pack size | 48tests/1 box |
| Storage temperature | 4-30°C |
| Shelf life | 10 months |
PRODUCT FEATURE
Principle
The Monkey Pox Antigen Test Cassette is a qualitative membrane strip based immunoassay for the detection of Monkey Pox antigen in oropharyngeal swab specimen. In this test procedure, anti-Monkey Pox antibody is immobilized in the test line region of the device. After a oropharyngeal swab specimen is placed in the specimen well, it reacts with anti-Monkey Pox antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-Monkey Pox antibody. If the specimen contains Monkey Pox antigen, a colored line will appear in the test line region indicating a positive result.
MAIN COMPONENTS
The kit contains reagents for processing 48 tests or quality control, including the following components:
①Anti-Monkey Pox antibody as the capture reagent, another anti- Monkey Pox antibody as the detection reagent.
②A Goat anti-Mouse IgG is employed in the control line system.
Storage Conditions And Shelf Life
1.Store as packaged in the sealed pouch at room temperature or refrigerated (4-30°C)
2.The test is stable to the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use.
3.DO NOT FREEZE. Do not use beyond the expiration date.
Applicable Instrument
The Monkey Pox Antigen Test Cassette is designed for use with oropharyngeal swabs.
(Please have the swab performed by a medically trained person.)
Sample Requirements
1.Applicable sample types: Oropharyngeal swabs. Please do not return the swab to its original paper wrapper. For best results, swabs should be tested immediately after collection. If it is not possible to test immediately, it is
strongly recommended that the swab is placed in a clean, unused plastic tube
labelled with patient information to maintain best performance and avoid possible contamination.
2.Sampling solution: After verification, it is recommended to use Virus preservation tube produced by Hangzhou Testsea biology for sample collection.
3.Sample storage and delivery: The sample can be kept tightly sealed in this tube at room temperature (15-30°C) for a maximum of one hour. Make sure that the swab is firmly seated in the tube and that the cap is tightly closed.
If a delay of more than one hour occurs, discard the sample. A new sample must be taken for the test.If specimens are to be transported, they should be packaged according to local regulations for the transport of atiological agents.
Testing Method
Allow the test, sample and buffer to reach room temperature 15-30°C (59-86°F) before running.
① Place the extraction tube in the Workstation.
② Peel off aluminum foil seal from the top of the extraction tube containing the
extraction tube containing the extraction buffer.
③ Have the oropharyngeal swab carried out by a medically trained person as
described.
④ Place the swab in the extraction tube. Rotate the swab for about 10 seconds
⑤ Remove the swab by rotating against the extraction vial while squeezing the sides
of vial to release the liquid from the swab.properly discard the swab.while pressing
the head of the swab against the inside of the extraction tube to expel as much liquid
as possible from the swab.
⑥ Close the vial with the provided cap and push firmly onto the vial.
⑦ Mix thoroughly by flicking the bottom of the tube.Place 3 drops of the sample
vertically into the sample window of the test cassette. Read the result after 10-15 minutes. Read the result within 20 minutes. Otherwise, a repetition of the test is recommended.
Results analysis
1.Positive:Two red lines appear. One red line appears in the control zone (C) and one red line in the test zone (T). The test is considered positive if even a faint line appears. The intensity of the test line can vary depending on the concentration of the substances present in the sample.
2.Negative: Only in the control zone (C) a red line appears, in the test zone (T) no line
appears. The negative result indicates that there are no Monkeypox antigens in the sample or the concentration of the antigens is below the detectionlimit.
3.Invalid: No red line appears in the control zone (C). The test is invalid even if there is a line in the test zone (T). Insufficient sample volume or incorrect handling are the most likely reasons for failure. Review the test procedure and repeat the test with a new test cassette.
Quality control
The test contains a coloured line that appears in the control zone (C) as an internal procedural control. It confirms sufficient sample volume and correct handling. Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and verify proper test performance.
Interfering substances
The following compounds were tested with the Monkey Pox rapid antigen test and no interferences was observed.
