• November 27, 2021
sars cov 2 antigen rapid test kit

Centro Diagnostico Delta Sars cov 2 Antigen Rapid Test Kit

Effectivity Traits

JOYSBIO’s coronavirus Ag check out tools was independently evaluated at Centro Diagnostico Delta S.r.l. in Italy between October 2020 and January 2021. An entire of 107 constructive specimens had been examined with JOYSBIO’s COVID-19 Antigen Speedy Test Tools. These specimens had been collected from victims who’re suspected of COVID-19 with nasal swabs. The coronavirus antigen check out tools’s sensitivity and specificity are in distinction in the direction of a CE-IVD marked RT-PCR check out tools. This medical evaluation is carried out beneath the concept that SARS-CoV isn’t spreading regionally. 

Based mostly on the medical analysis of 492 samples, the detection sensitivity is 98.13%, and the specificity is 99.22%.

  • Constructive % Settlement (PPA) = 105/107 (98.13%) (95%CI: 93.4%~99.8%)
  • Antagonistic % Settlement (NPA) = 382/385 (99.22%) (95%CI:97.7%~99.8%)
  • Accuracy = (105+382)/492×100%=98.98%
  • Kappa = 2×(105×382-3×2)/(108×385+107 ×384) = 0.97>0.5

The limit of detection (LOD) of this product is 1.6 x 102 TCID50/mL, calculated by way of a gradient dilution methodology.

Please Observe:

 Underneath listed kits are validated with the talked about batch amount solely. Obligation for batch to batch consistency would not lies with ICMR.
 Minimal acceptance requirements of sensitivity and specificity of Speedy Ag Test Kits:
 Validated as a Stage of Care Test (POCT) with out transport to a laboratory setupSensitivity: 50% and above; Specificity: 95% and above
 Validated in a laboratory setup with samples collected in Viral Transport Medium (VTM)- Sensitivity: 70% and above; Specificity: 99% and above
 Antigen based speedy assessments which can be US-FDA permitted might be utilized instantly after due promoting and advertising and marketing approval from DCGI.

 

In June 2020, JOYSBIO Biotechnology proudly launched a model new COVID-19 Antigen Speedy Test Tools (Colloidal Gold). The model new coronavirus antigen check out tools is a lateral transfer immunoassay for the qualitative detection of SARS-COV-2 antigen (nucleocapsid protein) in larger respiratory samples with nasal swabs or saliva in the midst of the acute part of an an infection. An uncut sheet format is on the market.

Choices

  • 15-minute speedy detection
  • Simple-to-operate coronavirus antigen check out
  • A lot less-invasive nasal (NS) swab sample assortment
  • CE-IVD marked
  • Accessible in half/5/20 assessments/subject.

COVID-19 Antigen Test Course of

  1. Twist off the cap of the buffer bottle, fastidiously dispense all buffer into the extraction tube。 
  2. After accumulating larger respiratory sample with nasal swab, insert the swab into the extraction tube, plunge the swab up and down throughout the fluid for at least 10 seconds. Keep the swab in the direction of the underside of the tube, rotate three turns. DO NOT splash liquid out of the tube. 
  3. Take away the swab whereas squeezing the sides of the tube to extract the liquid from the swab. 
  4. Press the nozzle cap firmly onto the extraction tube. Mix utterly by swirling or flicking the underside of the tube. 
  5. Gently squeeze the tube’s rigid physique, dispense two (2) drops of the buffer-specimen mixture into the sample properly on the coronavirus antigen check out cassette.
  6. Study the check out outcomes between 15 and 20 minutes. Do not study the outcomes after 20 minutes.
sars cov 2 infection
sars cov 2 infection

Key Components

  • This interim guidance is supposed for healthcare suppliers who order antigen assessments, receive antigen check out outcomes, or perform point-of-care testing, along with for laboratory professionals who perform antigen testing in a laboratory setting or on the extent of care and report these outcomes.
  • The intention of this interim technical guidance is to assist environment friendly medical and public nicely being use of antigen assessments for varied testing situations.
  • This guidance applies to all medical and shopper makes use of of antigen assessments and is not specific to any particular age group.

Abstract

Background

The Coronavirus sickness 2019 (COVID-19) pandemic continues to unfold internationally. Due to this fact, there’s an urgent need for quick, straightforward, and proper assessments to diagnose excessive acute respiratory syndrome coronavirus 2 (SARS-CoV-2) an an infection. Effectivity traits of the speedy SARS-CoV-2 antigen detection check out must be evaluated and in distinction with the gold customary real-time reverse transcription-polymerase chain response (RT-PCR) check out for prognosis of COVID-19 situations.

Methods

The speedy SARS-CoV-2 antigen detection check out, Customary Q COVID-19 Ag tools (SD Biosensor®, Republic of Korea), was in distinction with the real-time RT-PCR check out, Allplex 2019-nCoV Assay (Seegene®, Korea) for detection of SARS-CoV-2 in respiratory specimens. Four hundred fifty-four respiratory samples (primarily nasopharyngeal and throat swabs) had been obtained from COVID-19 suspected situations and communicate to folks, along with pre-operative victims at Siriraj Hospital, Bangkok, Thailand all through March–Would possibly 2020.

Outcomes

Of 454 respiratory samples, 60 (13.2%) had been constructive, and 394 (86.8%) had been detrimental for SARS-CoV-2 RNA by real-time RT-PCR assay. The size from onset to laboratory check out in COVID-19 suspected situations and communicate to folks ranged from Zero to 14 days with a median of three days. The speedy SARS-CoV-2 antigen detection check out’s sensitivity and specificity had been 98.33% (95% CI, 91.06–99.96%) and 98.73% (95% CI, 97.06–99.59%), respectively. One false detrimental check out consequence was from a sample with a extreme real-time RT-PCR cycle threshold (Ct), whereas 5 false constructive check out outcomes had been from specimens of pre-operative victims.

Toxoplasma Antigen Rapid Test Card

C11352 15T Ask for price

NOVATest Antigen Rapid Test Kit (For Single Use) (NOVA Test)

nCov-500-01 1T
EUR 162

NOVATest Antigen Rapid Kit (NOVA Test)

nCov-500 20 Tests
EUR 162

CPV&CCoV Antigen Rapid Test Card

C11611 10T Ask for price

CPV&CCoV&GIA Antigen Rapid Test Card

C11601 10T Ask for price

Canine Parvovirus Antigen (CPV Ag) Rapid Test Kit

HG001 10 Tests/Kit
EUR 16.1
Description: Contents: (1) 10 Tests/Kit  (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Human Streptococcus Pneumoniae (SP) Antigen Rapid Test Kit

abx092096-20tests 20 tests
EUR 477.6

Canine Coronavirus Antigen (CCV Ag) Rapid Test Kit

HG003 10 Tests/Kit
EUR 16.1
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Feline Herpesvirus Antigen (FHV Ag) Rapid Test Kit

HG005 10 Tests/Kit
EUR 16.1
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Feline Calicivirus Antigen (FCV Ag) Rapid Test Kit

HG030 10 Tests/Kit
EUR 21
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Rapid Response COVID-19 Saliva Rapid Antigen Test

BSV-COV-2C25B 25 tests Ask for price
Description: Rapid Response COVID-19 Saliva Rapid Antigen Test

COVID-19 Antigen Rapid Test Pen (Saliva)

BSV-COV-2PEN20 20 pc Ask for price
Description: COVID-19 Antigen Rapid Test Pen (Saliva)

Feline Coronavirus Antigen (FCoV Ag) Rapid Test Kit

HG006 10 Tests/Kit
EUR 21
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

GA COVID-19 Rapid Antigen Test

BSV-3980 20 tests Ask for price
Description: GA COVID-19 Rapid Antigen Test

Avian Influenza Virus Antigen Rapid Test Kit (Colloidal gold)

abx092015-40tests 40 tests
EUR 518.4

Canine Distemper Virus Antigen (CDV Ag) Rapid Test Kit

HG002 10 Tests/Kit
EUR 16.1
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Canine Influenza virus Antigen (CIV Ag) Rapid Test Kit

HG028 10 Tests/Kit
EUR 16.1
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Feline Leukemia Virus Antigen (FeLv Ag) Rapid Test Kit

HG029 10 Tests/Kit
EUR 21
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Newcastle Disease Virus Antigen Rapid Test Kit (Colloidal gold)

abx092016-40tests 40 tests
EUR 518.4

Human Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal gold)

abx092049-20tests 20 tests
EUR 276

Feline Panleukopenia Virus Antigen (FPV Ag) Rapid Test Kit

HG004 10 Tests/Kit
EUR 16.1
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Avian Influenza H5 Virus Antigen Rapid Test Kit (Colloidal gold)

abx092014-40tests 40 tests
EUR 585.6

Avian Influenza H7 Virus Antigen Rapid Test Kit (Colloidal gold)

abx092017-40tests 40 tests
EUR 518.4

SARS-CoV-2 Rapid Antigen Test Nasal

9901-NCOV-03G 25 Tests/Kit
EUR 112.8
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

HG008 10 Tests/Kit
EUR 21
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Feline Panleukopenia Virus Antigen/Feline Herpesvirus Antigen (FPV/FHV) Rapid Test Kit

HG011 10 Tests/Kit
EUR 17.5
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Canine Relaxin Antigen (RLN Ag) Rapid Pregnancy Test Kit

HG043 10 Tests/Kit
EUR 16.1
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Canine Distemper Virus Antigen/Canine Adenovirus Antigen (CDV/CAV Ag) Rapid Test Kit

HG009 10 Tests/Kit
EUR 21
Description: Contents: (1) 10 Tests/Kit   (cassette,disposable dropper,desiccant) (2) 10 Assay buffer tubes (3) 10 Sterile swabs (4) 1 Instruction manual

Leave a Reply

Your email address will not be published. Required fields are marked *