Monkeypox Virus Igg Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HMKP055X
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

INTENDED USE
The Monkeypox virus IgG Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Monkeypox virus in human whole blood, serum, or plasma as an aid in the diagnosis of Monkeypox infections.

SUMMAR
MATERIALS

Materials Provided

Individually packed test devices Disposable pipettes

Package insert Buffer

Materials Required but Not provided

Centrifuge Micropipette

Timer Lancets

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.

For Serum or Plasma Specimens: 
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10 uL), and transfer the specimen to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 mL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 2 drops of whole blood (approximately 20 µL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below.
To use a micropipette: Pipette and dispense 20 µL of whole blood to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 µL) and start the timer.

1. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

 

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

 

PERFORMANCE CHARACTERIST

Cross-reactivity

Cross-reactivity of the Monkeypox virus IgG Rapid Test was evaluated using serum or plasma specimen which contain antibodies to the pathogens listed below. No false positive or false negative was found with the following.
HCoV-OC43 IgG
HCoV-HKU1 IgG
HCoV-229E IgG
HCoV-NL63 IgG
Influenza A IgM/IgG
Influenza B IgM/IgG
Legionella pneumophila IgM
Chlamydia pneumophila IgM/IgG
Mycoplasma pneumophila IgM
HRSV-IgM
Measles IgG
Mumps IgG
Mycobacterium tuberculosis
COVID19 IgG
Human Adenovirus IgG

Precision

Intra-Assay
Within-run precision has been determined by using 10 replicates of four specimens: a negative, an IgG positive, an IgM positive and an IgG dual positive. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 10 independent assays on the same four specimens: a negative, an IgG positive, an IgM positive and an IgG dual positive. Three different lots of the Monkeypox virus IgG Rapid Test have been tested using these specimens. The specimens were correctly identified >99% of the time.