In June 2020, JOYSBIO Biotechnology proudly launched a brand new COVID-19 Antigen Speedy Take a look at Package (Colloidal Gold). The brand new coronavirus antigen check equipment is a lateral circulation immunoassay for the qualitative detection of SARS-COV-2 antigen (nucleocapsid protein) in higher respiratory samples with nasal swabs or saliva in the course of the acute part of an infection. An uncut sheet format is out there.
Options
15-minute fast detection
Simple-to-operate coronavirus antigen check
Much less-invasive nasal (NS) swab pattern assortment
CE-IVD marked
Out there in half of/5/20 exams/field
Efficiency Traits
JOYSBIO’s coronavirus Ag check equipment was independently evaluated at Centro Diagnostico Delta S.r.l. in Italy between October 2020 and January 2021. A complete of 107 optimistic specimens have been examined with JOYSBIO’s COVID-19 Antigen Speedy Take a look at Package. These specimens have been collected from sufferers who’re suspected of COVID-19 with nasal swabs. The coronavirus antigen check equipment’s sensitivity and specificity are in contrast in opposition to a CE-IVD marked RT-PCR check equipment. This medical analysis is performed beneath the idea that SARS-CoV is now not spreading locally.
In line with the medical evaluation of 492 samples, the detection sensitivity is 98.13%, and the specificity is 99.22%.
The restrict of detection (LOD) of this product is 1.6 x 102 TCID50/mL, calculated via a gradient dilution methodology.
fast SARS-CoV-2 antigen detection assay
COVID-19 Antigen Speedy Take a look at Precept
The coronavirus antigen fast check equipment is a lateral circulation assay that qualitatively detects the presence of nucleocapsid (N) protein in higher respiratory samples (nasal swabs). This lateral circulation assay is designed with the sandwich immunoassay format. When the specimen is added onto the pattern pad of a check cassette, coronavirus N protein binds with colloidal gold-labeled SARS-CoV-2 N protein antibody to kind an antibody-antigen (Ab-Ag) complicated. The Ab-Ag complicated is captured by SARS-CoV-2 N protein antibody (Rabbit monoclonal antibody) when migrating to the check line beneath capillary motion. A red-colored band will seem on the check line, which signifies the specimen is COVID-19 nucleocapsid protein optimistic. No coloration band will seem on the check line if the specimen doesn’t comprise any coronavirus antigen (N protein), or the antigen degree is under detection restrict.
Twist off the cap of the buffer bottle, rigorously dispense all buffer into the extraction tube。
After amassing higher respiratory pattern with nasal swab, insert the swab into the extraction tube, plunge the swab up and down within the fluid for no less than 10 seconds. Maintain the swab in opposition to the underside of the tube, rotate three turns. DO NOT splash liquid out of the tube.
Take away the swab whereas squeezing the edges of the tube to extract the liquid from the swab.
Press the nozzle cap firmly onto the extraction tube. Combine totally by swirling or flicking the underside of the tube.
Gently squeeze the tube’s inflexible physique, dispense two (2) drops of the buffer-specimen combination into the pattern nicely on the coronavirus antigen check cassette.
Learn the check outcomes between 15 and 20 minutes. Don’t learn the outcomes after 20 minutes.
Stage 1: Nasopharyngeal swab specimen assortment:
1. Gather a nasopharyngeal swab specimen by inserting the sterile swab into the nostril.
2. Push the sterile swab till resistance is met on the degree of the turbinate.
3. Rotate the sterile swab a number of instances in opposition to the nasopharyngeal wall & depart within the place for 10 seconds to saturate the swab tip.
4. Take away the swab from the nostril rigorously.
5. Place the swab specimen into the viral transport medium buffer tube and shut the tube tightly.
6. Transport the swab pattern in VTM to the laboratory in chilly chain.
7. The pattern could be saved within the Room temperature (Beneath 30◦C) as much as 24 hrs from the time of pattern assortment or at 2 – 8◦C for as much as 48 hrs from the time of pattern assortment. Stage 2: Pattern preparation for testing:
1. Pattern preparation must be carried out in BSL-2 degree cupboard within the Laboratory.
2. Combine the swab specimen in VTM tube nicely (vortex roughly 3-5 seconds).
3. Switch 100 μL VITROS SARS-CoV-2 Antigen Extraction Buffer right into a labelled new pattern tube.
covid-19-antigen-rapid-test-kit
4. Add 400 μL viral pattern to the above tube (to take care of 1:Four ratio of extraction buffer: pattern)
5. Combine nicely (Cap/Plug the pattern tube and vortex roughly 3-5 seconds)
Stage 3: Pattern processing in VITROS methods:
1. Place/load the ready/extracted pattern tube in stage 2, after de-capping on to the VITROS® instrument V3600/V5600/XT7600; An quantity of 80 μL of extracted pattern is used for every willpower.
2. Program VITROS 3600 / VITROS 5600 / VITROS XT 7600 system to course of the samples for CV2Ag. The system can used to program check both in a STAT/Random/Batch mode.
3. System processes the samples mechanically utilizing disposable VersaTips for each pattern in addition to reagents to forestall any cross-contamination. The outcomes can be delivered in 48 minutes after pattern aspiration, within the type of S/Co worth.
Description: The SARS-CoV-2 Rapid Antigen Test is a lateral fl ow rapid chromatographic immunoassay for the qualitative detection of nucleocapsid antigen to SARS-CoV-2 present in human nasal samples. This test is intended for use as an aid in detection of SARS-CoV-2 infection in individuals suspected of COVID-19 with clinical symptoms onset within 5 days. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in human nasal swab samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. The SARS-CoV-2 Rapid Antigen Test is intended for use in laboratory or POC settings by healthcare professionals, or self-collection under the supervision of a healthcare worke
Canine Parvovirus Antigen/Canine Coronavirus Antigen (CPV/CCV Ag) Rapid Test Kit
