PRODUCT NAME
MonkeypoxVirusAntigenRapidTestKit
SPECIFICATION
25tests/kit, 5 tests/kit, 1 test/kit
INTENDEDUSE
Monkeypox VirusAntigen Rapid Test is a lateral flow chromatographic immunoassayfor the qualitative detection of monkeypox virus antigen in human rash exudates andbloodsamples.
INTRODUCTION
Monkeypoxisaviralzoonosis.ItspathogenmonkeypoxvirusisaDNAvirus,belongingto the genus orthopoxvirus of poxviridae, which is "close relative" to smallpox virus.Rodents are most likely to be natural hosts, and animals such as squirrels, Gambianrats and different kinds of monkeys may be infected. It is mainly prevalent in Westernand Central Africa. Most of the cases reported so far are distributed in Africancountries such as the Democratic Republic of the Congo, the CentralAfrican Republicand Nigeria. The first human infection was found in the Democratic Republic of theCongo in 1970, and the first epidemic outside the African continent occurred in theUnited States in 2003. Since 2018, Israel, Britain, Singapore and other countries havefound infected people among passengers from Nigeria, Direct contact with the blood,body fluid, skin or mucous membrane of infected animals,eating improperly cookedinfected animals is risk factor. Interpersonal transmission refers to close contact withthe infected person and may be infected, including close contact with the respiratorysecretions, skin damage parts or contaminated articles of the infected person;Prolonged face-to-face contact may cause respiratory droplet transmission; Mother tochild transmission may occur through placenta or close contact during childbirth.
The incubation period is usually 6 to 13 days and may be as long as 21 days; Earlysymptoms include fever, headache, enlarged lymph nodes, muscle soreness, severefatigue and so on; Then it develops into a large-scale rash on the face and body,which may lead to secondary infection, bronchopneumonia, sepsis, etc; Most patientsrecover within a few weeks. Severe cases are common in children or people withimmunedeficiency.Theyarealsorelatedtothebasichealthstatusofinfectedpeople,thedegreeofexposuretovirusandtheseverityofcomplications;Themortalityrateofthe epidemic varies greatly, about 3% to 6% in recent years.
PRINCIPLE
MonkeypoxVirusAntigenTestusedoubleantibodysandwichmethod.Duringthetest,a specimen is dropped into the hole, and then the specimen is superimposed underthe capillary effect. If the specimen contains monkeypox virus antigen , A color bandappearsinthetestarea(T)indicateapositiveresultformonkeypoxvirusantigen.Ifthespecimendoesnotcontainthecorrespondingsubstancetobetested,therewillbenocolorbandsinthetestarea(T),andtheresultwillbenegative. A colorband appears in the quality control area (C) regardless of whether the correspondingsubstance to be tested is present in the specimen. The color band in the qualitycontrol area (C) is the standard to determine whether there are enough specimensand whether the chromatographic process is normal, and also serves as the internalcontrol standard of the test.
 
ControlLineTestLine            SampleWell

MAINCOMPONENTS
Materials Provided

Components	25tests/kit	5 tests/kit	1 tests/kit
Cassettes	25 cassettes withdependentsealedfoilpouch	5 cassettes withdependentsealedfoilpouch	1 cassette withdependentsealedfoilpouch
Sample Diluent SolutionWithDropper	25tubes	5tubes	1 tube
CottonSwab	25pcs	5 pcs	1 pcs
Transfertube	25pcs	5 pcs	1 pcs
Packageinsert	1 pcs	1 pcs	1 pcs

MATERIALSREQUIREDBUTNOTPROVIDED

• Specimencollectioncontainer.
• Centrifuge
• Clock, timer or stopwatch
• Disposablelatexgloves

PRECAUTIONS

• Thistestisonlyusedforinvitrodiagnosis.
• Iftherearetoofewviralantigens,itwillcausefalse negatives.
• Thetestis disposable.
• Thistestisforvisualtesting.Toavoidmisjudgment,pleasedonotreaditindim light.
• Usedtestsandspecimensshouldbeproperlydisposedofasmedicalwastewitharisk of biological transmission.

STORAGEAND STABILITY

• 2~30°Cdryandstoredawayfromlight,validfor24months.
• Productiondateandservicelife:seelabel,donotfreezeoruseafterexpiry date.
• Thecassetteshouldbeusedwithin1hourafterthetearofthealuminumfoilbag;Ifthe temperature is higher
• than30°Corinhighhumidityenvironment,itshouldbetouseimmediately.

SPECIMENCOLLECTIONANDHANDLING
Consider any materials of human origin as infectious and handle them using standardbio- safety procedures.
Plasma:

1. Collectbloodspecimenintoalavender,blueorgreentopcollectiontube(containingEDTA, citrate or heparin, respectively, in vacuum blood collection vessel) byvenipuncture.
2. Separatetheplasmabycentrifugation.
3. Carefullywithdrawtheplasmaintoanewpre-labeledtube.

Serum:

1. Collect blood specimen into a red top collection tube (containing no anticoagulantsin vacuum blood collection vessel) by venipuncture.
2. Allowthebloodto clot.
3. Separatetheserumby centrifugation.
4. Carefullywithdrawtheserumintoanewpre-labeledtube.

Test specimens as soon as possible after collecting. Store specimens at 2°C~8°C ifnot tested immediately.
Specimens can be stored at 2°C~8°C for up to 5 days. The specimens should befrozen at -20°C for longer storage.
Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to roomtemperature slowly and mix gently. Specimens containing visible particulate mattershould be clarified by centrifugation before testing.
Donotusesamplesdemonstratinggrosslipemia,grosshemolysisorturbidityinorderto avoid interference on result interpretation.
WholeBlood:
Drops of whole blood can be obtained by either finger tip puncture or venipuncture.Wholebloodspecimensshouldbestoredinrefrigeration(2°C~8°C),ifnottestedimmediately. The specimens must be tested within 24 hours of collection.
Rash Exudate:

1. Wipetherashexudatewithasterileswab;
2. Inserttheswabintotheextractiontubewithbuffer;
3. Roll the swab at least 6 times while pressing the head against the bottom and sideof the extraction tube.
4. Leavetheswabintheextractiontubefor1 minute.

 

1. Squeezethetubeseveraltimeswithfingersfromoutsideofthetubetoimmersetheswab. Remove the swab. The extracted solution will be used as test sample.

TEST PROCEDURE
Read the instructions thoroughly before testing and bring the device and specimen toroomtemperature.
ForPlasma/Serum/WholeBlood:

1. Bring the specimen and test components to room temperature if refrigerated orfrozen. Once thawed, mix the specimen well prior to performing the assay.
2. When ready to test, open the pouch at the notch and remove the test cassette.Place the test cassette on a clean, flat surface.
3. Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense1 drop of serum/plasma or 1 drop of whole blood into the sample well, making surethere are no air bubbles.
4. Immediately add 1 drop (about 35-50 μL) of buffer with the bottle positionedvertically.
5. Wait for colored line(s) to appear. Interpret the test results in 15 minutes. Do notread results after 20 minutes.

ForRashExudate:

1. Remove test cassette from the sealed pouch just prior to the testing and lay flat onworkbench.
2. Insertanozzlewithfilterintothesampleextractiontubetightly.
3. Reversethesampleextractiontube,andadd3dropssamplebysqueezingtheextracted solution tube into the sample window.
4. Wait for colored line(s) to appear. Interpret the test results in 15 minutes. Do notread results after 20 minutes.

RESULTINTERPRETATION
POSITIVE: Two distinct red lines appear. One line should be in the control region(C)and the other line should be in the test region(T).
 
 
 
Note: The color bands in the test area (T) may appear in different shades of color.However, within the specified observation time, no matter the color of the color bandis dark or light, even if there is only a very weak color band, it should be judged as apositiveresult.
NEGATIVE: One red line appears in the control region(C). No red line appears in thetest region(T).The negative result does not indicate the absence of analyses in thesample, it only indicates the level of tested analyses in the sample is less than cut-offlevel.
 
 
 
 
INVALID: No colored lines appear, or control line fails to appear, indicating that theoperator error or reagent failure. Verify the test procedure and repeat the test with anew testing device.
 
 
 
 
LIMITATIONSOFPROCEDURE

• ThepositiveresultsofMonkeypoxVirusAgTestcannotexcludetheinfectionofotherpathogens other than Monkeypox Virus.
• MonkeypoxVirusAgTestcanonlyqualitativelydetectMonkeypoxVirusinthespecimen, and cannot indicate the content of virus in the specimen.
• MonkeypoxVirusAgTestisonlyusedforpreliminaryscreening.Ifitisnecessaryto confirm the diagnosis, clinical symptoms or further laboratory tests should beperformed.

QUALITYCONTROL
Aproceduralcontrolisincludedinthetest.Thelineappearinginthecontrolregion(C)is considered an internal procedural control. It confirms sufficient specimen volume,adequate membrane wicking and correct procedural technique.
Controlstandardsarenotsuppliedwiththiskit.However,itisrecommendedthat

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