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Rash Exudate Swab Infectious Disease Testing For Monkeypox Virus

Brand Name:	ALLTEST
Model Number:	IMXG-402
MOQ:	N/A
Price:	negotiation
Payment Terms:	Ex works, L/C, T/T
Supply Ability:	10 M tests/month

Detail Information

Product Description

Detail Information

Place of Origin:

China

Certification:

Product:

Monkeypox Virus Antigen Rapid Test

Principle:

Chromatographic Immunoassay

Specimen:

Rash Exudate Swab , Throat Swab, WB/S/P

Certificate:

Reading Time:

10-20 Minutes

Sensitivity:

93.75%

Specificity:

99.50%

Accuracy:

99.07%

Packaging Details:

10T/25T

Supply Ability:

10 M tests/month

Highlight:

Monkeypox Virus Antigen Rapid Test

Rash Exudate Swab Infectious Disease Testing

Monkeypox Virus Infectious Disease Testing

Product Description

Monkeypox Virus Antigen Rapid Test , Rash Exudate Swab, Infectious Disease Testing

Product:	Monkeypox Virus Antigen Rapid Test
Specimen:	Rash Exudate Swab , Throat Swab, WB/S/P
Reading Time:	10-20 Minutes
Specificity:	99.50%
Principle:	Chromatographic Immunoassay
Certificate:	CE
Sensitivity:	93.75%
Accuracy:	99.07%

Monkeypox Virus Antigen Rapid Test , Rash Exudate Swab, Infectious Disease Testing

For professional in vitro diagnostic use only.

INTENDED USE

The Monkeypox Virus Antigen Rapid Test is a rapid chromatographic immunoassay intended for the qualitative detection of monkeypox virus A29L antigen in human serum,plasma, whole blood, rash exudate and throat swab specimens. It is intended for use asan aid in the diagnosis of monkeypox virus infection. Results are for the detection ofmonkeypox virus antigen. Positive results indicate the presence of monkeypox virus antigen.

SUMMARY

Monkeypox is considered a zoonotic disease with transmission primarily occurring from animals, such as rodents and primates, to humans. However, limited sustained human-to-human transmission has been observed with up to 6 generations of human-to-human transmission being previously identified. Transmission of the virus can occur through contact with bodily fluids, wounds on the skin or internal mucosal surfaces, respiratory droplets, or contaminated objects. Consumption of inadequately

cooked meat or other products from infected animals may also pose increased risks of infection.

The incubation period for monkeypox can range from 5–21 days but usually falls within 7–14 days. Clinical presentation of monkeypox can be similar to chickenpox, caused by varicella-zoster virus.2 Symptoms usually begin within 5 days of infection with fever and chills, headache, muscle aches, back pain, fatigue, and swollen lymph nodes (lymphadenopathy), the latter symptom differentiating monkeypox from smallpox and chickenpox. About 1–3 days, sometimes longer, after the initial onset of symptoms, a rash or lesions can appear, usually beginning on the face and spreading throughout the body, often to the extremities rather than the trunk. Notably, monkeypox lesions can appear on the palms of the hands and soles of the feet (75% of cases). Most individuals with monkeypox experience rash with 1 to >100 skin lesions, but some do not experience these lesions.

In most patients, symptoms of monkeypox are usually self-limiting and spontaneously resolve within 14-21 days. However, symptoms can be severe and require medical care.

PRINCIPLE

The Monkeypox Virus Antigen Rapid Test is a qualitative, lateral flow immunoassay for the detection of monkeypox virus A29L antigen in human serum, plasma, whole blood, rash exudate and throat swab specimens. The membrane is pre-coated with anti-MPX A29L on the test line region. During testing, monkeypox virus antigen in the serum, plasma, whole blood, rash exudate and throat swab specimen reacts with the particle coated with MPX A29L antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with monkeypox virus antibody on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

PRECAUTIONS

1. This package insert must be read completely before performing the test. Failure to follow directions in package insert may yield inaccurate test results.

2. For professional in vitro diagnostic use only. Do not use after the expiration date.

3. Do not eat, drink or smoke in the area where the specimens or kits are handled.

4. Do not use the test if the pouch is damaged.

5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the collection, handling, storage and disposal of patient samples and the disposal of used kit contents.

6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

7. Wash hands thoroughly after testing.

8. Please ensure that appropriate amounts of samples are used for testing. Too much or too little may lead to deviation of results.

9. The used test should be discarded according to local regulations.

10.Humidity and temperature can adversely affect results.

11.Where use of a centrifuge is required for a procedure, safety cups or sealed rotors should be used.

SPECIMEN COLLECTION AND PREPARATION

Rash Exudate Swab or Throat Swab

For rash exudate, wipe the rash exudate 5 laps with a sterile swab. For throat swab, insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsilla illarsand posterior oropharynx 5 laps and avoid touching the tongue, teeth, and gums.

Swab specimens should be tested as soon as possible after collection If swabs are not been processed immediately, it is highly recommended the swab sample is placed into a dry, sterile and tightly sealed plastic tube for storage. The swab specimen in dry and sterile condition is stable for up to 24 hours at 2-8°C.

Whole Blood, Serum or Plasma

Collect whole blood specimen into a collection tube (with specified anticoagulant, namely EDTA K2, heparin sodium, sodium citrate or potassium oxalate) according to standard venous blood sampling process. Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzed specimens can be used.

Testing should be performed immediately after the specimens have been collected.

Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 10 days. For long term storage, they should be kept below -20°C. Whole blood specimens should be stored at 2-8°C if the test is to be run within 3 days after collection. Do not freeze whole blood specimens.

Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents. EDTA-K2, Heparin sodium, Citrate sodium and Potassium Oxalate can be used as

the anticoagulant for collecting the specimen.

DIRECTIONS FOR USE

Allow the test, specimen and buffer equilibrate to room temperature (15-30°C) prior to testing.

1. Remove the test cassette from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2. Place the test on a flat and clean surface, and run test as below for different specimen.

Rash Exudate Swab or Throat Swab

For Rash Exudate or Throat Swab specimen:

1. Remove the cover of the tube with extraction buffer and place the tube in the workstation.

2. For rash exudate, wipe the rash exudate 5 laps with a sterile swab. For throat swab, insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsillar pillarsand posterior oropharynx 5 laps and avoid touching the tongue, teeth,

and gums.

3. Place the swab into the extraction tube. Rotate the swab for 10-15 seconds while pressing the head against the inside of the tube to release the antigen in the swab.

4. Remove the swab while squeezing the swab head against the inside of the extraction tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol.

5. Fit the tube tip or close the cap onto the tube, then invert the extraction tube and add 2 drops of specimen (approximately 50 μL) into the specimen well (S) and then start the timer.

6. Wait for the colored line (s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.

Whole Blood, Serum or Plasma

1. For Serum or Plasma specimen:

Use a dropper: Hold the dropper vertically, transfer 2 full drops (approximately 50 μL) of Serum or Plasma to the Specimen well (S). Start the timer.

Use a pipette: Transfer 50 μL of Serum or Plasma to the Specimen well(S).Start the timer.

For Whole blood specimen:

Use a dropper: Hold the dropper vertically, transfer 3 full drops (approximately 75 μL) of Whole blood to the Specimen well (S). Then add 2 drops of buffer (approximately 50 μL) to the Specimen well (S), and start the timer.

Use a pipette: Transfer 75 μL of Whole blood to the Specimen well(S), then add 2 drops of buffer (approximately 50 μL) to the Specimen well (S), and start the timer.

2. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.

Note: It is suggested not to use the buffer beyond 6 months after opening the vial.

INTERPRETATION OF RESULTS

POSITIVE:* Two colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T). Positive result in the test region indicates monkeypox virus antigen was detected in the specimen.

*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of monkeypox virus antigen present in the sample. So any shade of color in the test region (T) should be considered positive.

NEGATIVE: One colored line appears in the control region (C). No colored line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

The emergence and spread of infectious diseases pose a continuing challenge in the ever-changing global health landscape. Two notable examples, monkeypox and COVID-19, have attracted widespread attention and it is critical to examine the salient features of each outbreak and reliable rapid detection solutions to address them.

Monkeypox and COVID-19: Divergent Paths, Shared Complexities

Monkeypox and COVID-19 are both viral infections, but their epidemiologic characteristics and clinical manifestations are quite different. Monkeypox has historically been confined to central and western Africa and has recently experienced a global re-emergence with cases reported on several continents. In contrast, COVID-19, caused by the SARS-CoV-2 virus, has evolved into a global epidemic affecting populations worldwide.

One key difference is the mode of transmission. Monkeypox is transmitted primarily through prolonged close contact with infected individuals, their body fluids or contaminated surfaces, whereas COVID-19 is more readily transmitted through respiratory droplets and aerosols. Clinically, monkeypox usually presents as a distinctive rash, often accompanied by fever, enlarged lymph nodes and other systemic symptoms. COVID-19, on the other hand, is known for a wide range of symptoms, from mild respiratory illness to severe pneumonia, acute respiratory distress syndrome and multisystem involvement. Although monkeypox and COVID-19 are characterized differently, they share the common challenge of timely and accurate diagnosis, which is essential for effective management and public health interventions.

The Role of Reliable Rapid Testing: AllTest's Comprehensive Solutions

In the face of these evolving health challenges, it has become critical to provide reliable rapid testing solutions. AllTest, a leading manufacturer of in vitro diagnostic products, offers trusted solutions for Monkeypox as well as COVID-19 rapid testing, giving healthcare providers the tools they need to address these complexities.

AllTest offers rapid test kits that provide results in minutes. The high sensitivity and specificity of these rapid tests allow for early detection of infected individuals, facilitating prompt quarantine and contact tracing measures. The results of these tests, validated to the highest standards, are accurate and reliable for effective case screening, surveillance and monitoring.

The versatility of AllTest rapid testing solutions is not limited to clinical applications. From healthcare facilities and laboratories to community screening programs, these tests can be seamlessly integrated into a variety of settings, enabling a wide range of stakeholders to make informed decisions and implement effective public health strategies.

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products details

Rash Exudate Swab Infectious Disease Testing For Monkeypox Virus

Rash Exudate Swab Infectious Disease Testing For Monkeypox Virus

Monkeypox Virus Antigen Rapid Test

Rash Exudate Swab Infectious Disease Testing

Monkeypox Virus Infectious Disease Testing