Adenovirus Antigen Vapid Test

Adenovirus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human Adenovirus antigen in human stool specimen. The test results are intended to aid in the diagnosis of adenovirus infection and to monitor the effectiveness of therapeutic treatment.

Riassuntu

Infantile diarrhea is a group of common pediatric diseases caused by multiple causes and factors, characterized by increased stool frequency and changes in stool characteristics. 80% of infantile diarrhea is caused by virus. The main pathogen of viral enteritis is rotavirus, followed by enterovirus, such as intestinal adenovirus.

Type 40 and 41 adenoviruses can cause gastroenteritis, abdominal pain and diarrhea in infants and young children (under 4 years old). Group C adenovirus can cause intussusception in some infants.

MATERIALI

Almacenamentu è stabilità

• U kit deve esse guardatu à 2 - 30 ° C finu à a data di scadenza stampata nantu à a sacchetta sigillata.
  A prova deve stà in u sbuffatu sigillatu finu à l'usu.
  Ùn congelate micca.
  Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.

Principiu

Adenovirus Antigen Rapid Test is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of diluted stool sample is added to the sample well of the test cassette. The sample flows through a pad containing antibodies against adenovirus coupled to red-colored colloidal gold. If the sample contains adenovirus antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region on which adenovirus specific antibodies are immobilized separately. As the complexes reach the test line, they will bind to the antibody corresponding to the virus on the membrane to form of a line. A red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If virus is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.

Procedura di prova

Portate e teste, specimens, è / o cuntrolli à a temperatura ambienti (15 - 30 ° C) prima di l'usu.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
2. Preparazione di specimen

Unscrew the sample bottle, use the attached applicator stick attached on the cap to transfer small piece of stool (4-6 mm in diameter; approximately 50 mg – 200 mg) into the sample bottle containing specimen preparation buffer . For liquid or semi-solid stools, add 100 microliters of stool to the vial with an appropriate pipette. Replace the stick in the bottle and tighten securely. Mix stool sample with the buffer thoroughly by shaking the bottle for a few seconds.

3. PROCEDURA DI ASSAIN

3.1 Hold the sample bottle upright with the tip point toward the direction away from the test performer, snap off the tip.

3.2. Hold the bottle in a vertical position over the sample well of the test card, deliver 3 drops (120-150 μL) of diluted stool sample to the sample well (S) and start the timer.

Evitate di trappà e bolle d'aria in u mo specimen bè (i), è ùn aghjunghjenu micca alcuna suluzione à u risultatu di u risultatu.

Cumu a prova cumencia à travaglià, u culore migrà à traversu u risultatu di u risultatu in u centru di u dispusitivu.

3.3. Wait for the colored band(s) to appear. Read the result between 5 - 10 minutes. A strong positive sample may show result earlier.

Ùn interpretate micca u risultatu dopu à 10 minuti.

Cumu a prova cumencia à travaglià, u culore migrà à traversu u risultatu di u risultatu in u centru di u dispusitivu.

Interpretazione di risultati

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.

Nota:

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.

Sensibilità relative: 99,40% (95% CI: 96,69% ​​~ 99,98%)

Specifica relativa: 99,56% (95% CI: 97,56% ~ 99,99%)

A precisione: 99,26% (95% CI: 98.17% ~ 99,94%)