1 - New Coronavirus (COVID-19) Antigen Rapid Test Kit (swab)

New Coro­n­avirus (COVID-19) Intro­duc­tion

The 2019 nov­el coro­n­avirus, abbre­vi­at­ed as SARS-CoV-2, is a nov­el strain of coro­n­avirus dis­cov­ered in the human body. The symp­toms of the virus are fever, fatigue, dry cough, and pro­gres­sive dys­p­neal. In severe cas­es, the symp­toms are acute res­pi­ra­to­ry dis­tress syn­drome, sep­tic shock, meta­bol­ic aci­do­sis and coag­u­la­tion dys­func­tion that can’t be reversed. The virus has been con­firmed the capac­i­ty of human-to-human trans­mis­sion ; the short­est incu­ba­tion peri­od of the virus is only 1 day, while the longest is 14 days.

Prod­uct Infor­ma­tion of New Coro­n­avirus (COVID-19) Anti­gen Rapid Test Kit (swab)

NameSpec­i­menPack­ageStor­age Conditions
New Coro­n­avirus
(COVID-19) Anti­gen Rapid Test Kit (swab)
Nasal Swab and nasal
aspi­rate samples
25 Tests/​box4-30°C stor­age in dark and
dry

Prod­uct Image

1 - New Coronavirus (COVID-19) Antigen Rapid Test Kit (swab)
2 - New Coronavirus (COVID-19) Antigen Rapid Test Kit (swab)
3 - New Coronavirus (COVID-19) Antigen Rapid Test Kit (swab)

Prod­uct Characteristics

Test sam­ple : Nasal Swab and nasal aspi­rate sam­ples
Short detec­tion time : Rapid detec­tion of nov­el coro­n­avirus with­in 15 min­utes (SARS-CoV-2)
Instru­men­ta­tion required : No need for instru­ments and equip­ment, suit­able for rapid screen­ing
Suit­able for pri­ma­ry screen­ing : Screen­ing for sus­pect­ed nov­el coro­n­avirus patients

Intend­ed Use

New (Nov­el) Coro­n­avirus (COVID-19) Anti­gen Rapid Test (swab) is an in vit­ro diag­nos­tic test for the qual­i­ta­tive detec­tion of nov­el coro­n­avirus anti­gens in Nasal Swab and nasal aspi­rate sam­ples, using the rapid immunochro­mato­graph­ic method. The iden­ti­fi­ca­tion is based on the mon­o­clon­al anti­bod­ies spe­cif­ic for the New Coro­n­avirus anti­gen. It will pro­vide infor­ma­tion for clin­i­cal doc­tors to pre­scribe cor­rect medications.

Instruc­tion For Use

Spec­i­men Collection

  1. Nasal Aspi­ra­tion
    Col­lect nasal aspi­rate flu­ids using the spe­cif­ic aspi­ra­tor as instructed.
  2. Nasal Swab­bing
    Com­plete­ly insert the ster­il­ized swab sup­plied in this kit into the nasal basin, and swab sev­er­al times to col­lect the epi­der­mal cells of the mucus. It is rec­om­mend­ed to col­lect sam­ple from nasal basin for more accu­rate results.

Spec­i­men preparation

Add 8 drops (about 0.24 mL) of the sam­ple extrac­tion buffer into the extrac­tion tube sup­plied in this kit, and put it on the tube stand.
(1) Nasal Aspi­rate Flu­ids
Add 8 drops (about 0.24 mL) of the nasal aspi­rate flu­ids into the extrac­tion tube which con­tains 0.3mL of the extrac­tion buffer, and mix well to be used as test sam­ple.
(2) Nasal Swabs
Insert the swab into the extrac­tion tube which con­tains 8 drops (about 0.24 mL) of the extrac­tion buffer. Rotate the swab inside the tube using a cir­cu­lar motion to roll the side of the extrac­tion tube
so that liq­uid is expressed and reab­sorbed from the swab. Remove the swab. The extract­ed solu­tion will be used as test sample.

Test Process

Test process

  1. Remove the test device from the sealed foil pouch and use it with­in 0.5 hour. Best results will be
    obtained if the assay is per­formed imme­di­ate­ly after open­ing the foil pouch
  2. 1). Put the buffer ves­sel in an upright posi­tion.
    2). Gen­tly tap on the upper half of the ves­sel, ensure all buffer has flown to the bot­tom.
    3). Twist the ves­sel neck until it breaks.
    4). Place the ves­sel above the Extrac­tion Tube, upside down. Squeeze the ves­sel hard until every drop of buffer has been trans­ferred to the Extrac­tion Tube.
  3. Place the swab spec­i­men in the Extrac­tion Tube Rotate the swab for approx­i­mate­ly 8 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 drop­per tip on top of the extrac­tion tube. Place the test device on a clean and lev­el surface.
  6. Add three drops of the solu­tion (approx. 80uL) to the sam­ple well and then start the timer. Read the result at 15 min­utes. Do not inter­pret the result after 20 minutes.

Schemat­ic Dia­gram Of Test Process

4 - New Coronavirus (COVID-19) Antigen Rapid Test Kit (swab)

Inter­pre­ta­tion of Assay Result

  1. Pos­i­tive : Two red lines appear. One red line appears in the con­trol region (C), and one red line in the test region (T). The shade of col­or may vary, but it should be con­sid­ered pos­i­tive when­ev­er there is even a faint line.
  2. Neg­a­tive : Only one red line appears in the con­trol region (C), and no line in the test region (T). The neg­a­tive result indi­cates that there are no New Coro­n­avirus par­ti­cles in the sam­ple or the num­ber of
    viral par­ti­cles is below the detectable range.
  3. Invalid : No red line appears in the con­trol region (C). The test is invalid even if there is a line on test region (T). Insuf­fi­cient sam­ple vol­ume or incor­rect pro­ce­dur­al tech­niques are the most like­ly rea­sons
    for con­trol line fail­ure. Review the test pro­ce­dure and repeat the test using a new test device. If the prob­lem per­sists, dis­con­tin­ue using the test kit imme­di­ate­ly and con­tact your local distributor.

Links

This prod­uct is devel­oped by our R&D com­pa­ny Wat­son Bio Ltd (https://​www​.wat​son​-bio​.com/), and here is the cor­re­spond­ing link https://​www​.wat​son​-bio​.com/​n​e​w​-​c​o​r​o​n​a​v​i​r​u​s​-​c​o​v​i​d​-​1​9​-​a​n​t​i​g​e​n​-​r​a​p​i​d​-​t​e​s​t​-​k​i​t​-​s​w​ab/

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