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Sars cov 2 antigen rapid test

sars cov 2 antigen rapid test kit

please pay attention:
The kits listed below are valid only with the batch number mentioned. ICMR is not responsible for batch-to-batch continuity.
Minimum Acceptance Criteria of Sensitivity and Specificity of Rapid Ag Test Kits
: Validated as point of care testing (POCT) without transport to laboratory setup Sensitivity: 50% and above; Specification: 95% and above
Validated in laboratory setup with samples collected in viral transport medium (VTM) – Sensitivity: 70% and higher; Specification: 99% and above
Antigen based rapid tests that are approved by the US-FDA may be used directly after appropriate marketing approval from the DCGI.

 

In June 2020, JOYSBIO Biotechnology proudly released a new COVID-19 Antigen Rapid Test Kit (Colloidal Gold). The new coronavirus antigen test kit is a lateral flow immunoassay for the qualitative detection of SARS-COV-2 antigen (nucleocapsid protein) in upper respiratory specimens with nasal swab or saliva during the acute phase of infection. An uncut sheet format is available.

Properties
15-minute rapid detection
Simple to Operate Coronavirus Antigen Test
Less-invasive nasal (NS) swab sample collection
CE-IVD Marked
Available in 1/2/5/20 trial/box.
Display Properties
JOYSBIO’s coronavirus Ag test kit was independently evaluated at Centro Diagnostico Delta Srl in Italy between October 2020 and January 2021. A total of 107 positive samples were tested with JOYSBIO’s COVID-19 Antigen Rapid Test Kit. These samples were collected from patients who are suspected of COVID-19 with swelling in the nose. The sensitivity and specificity of the Coronavirus Antigen Test Kit is compared with the CE-IVD marked RT-PCR Test Kit. This clinical evaluation is done under the assumption that SARS-CoV is no longer spreading in the community.

According to clinical analysis of 492 samples, the detection sensitivity is 98.13%, and the specificity is 99.22%.

Positive Percentage Agreement (PPA) = 105/107 (98.13%) (95% CI: 93.4% ~ 99.8%)
Negative Percentage Agreement (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 10 2 TCID 50 /mL, which is calculated via the gradient dilution method.

sars cov 2 antigen rapid test kit
sars cov 2 antigen rapid test kit

 

COVID-19 Antigen Test Procedure

  1. Twist off the cap of the buffer bottle, carefully dispense all buffer into the extraction tube。 
  2. After collecting upper respiratory sample with nasal swab, insert the swab into the extraction tube, plunge the swab up and down in the fluid for a minimum of 10 seconds. Hold the swab against the bottom of the tube, rotate three turns. DO NOT splash liquid out of the tube. 
  3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. 
  4. Press the nozzle cap firmly onto the extraction tube. Mix thoroughly by swirling or flicking the bottom of the tube. 
  5. Gently squeeze the tube’s rigid body, dispense two (2) drops of the buffer-specimen mixture into the sample well on the coronavirus antigen test cassette.
  6. Read the test results between 15 and 20 minutes. Do not read the results after 20 minutes.

Key Points

  • This interim guidance is intended for healthcare providers who order antigen tests, receive antigen test results, or perform point-of-care testing, as well as for laboratory professionals who perform antigen testing in a laboratory setting or at the point of care and report those results.
  • The purpose of this interim technical guidance is to support effective clinical and public health use of antigen tests for different testing situations.
  • This guidance applies to all clinical and consumer uses of antigen tests and is not specific to any particular age group.
sars-cov-2-rapid-antigen-test
sars-cov-2-rapid-antigen-test

Summary
background
The coronavirus disease 2019 (COVID-19) pandemic continues to spread around the world. Therefore, there is an urgent need for rapid, simple and accurate tests for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The performance characteristics of the rapid SARS-CoV-2 antigen detection test should be evaluated and compared with the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) test for diagnosis of COVID-19 cases.

methods
Rapid SARS-CoV-2 antigen detection test, Standard™ Q COVID-19 Ag kit (SD Biosensor®, Republic of Korea), compared with real-time RT-PCR test, Allplex™ 2019-nCoV assay (Seegene®) Went. , Korea) for the detection of SARS-CoV-2 in respiratory samples. Four hundred fifty-four respiratory samples (mainly nasopharyngeal and throat swabs) were obtained from COVID-19 suspected cases and contact persons, including pre-operative patients, at Siriraj Hospital, Bangkok, Thailand during March–May 2020.

Result
Of the 454 respiratory samples, 60 (13.2%) were positive, and 394 (86.8%) were negative for SARS-CoV-2 RNA by real-time RT-PCR assay. The period from onset to laboratory testing in COVID-19 suspected cases and contact persons ranged from 3 days with an average of 0 to 14 days. The sensitivity and specificity of the rapid SARS-CoV-2 antigen detection test were 98.33% (95% CI, 91.06–99.96%) and 98.73% (95% CI, 97.06–99.59%), respectively. One false negative test result was from a sample with a high real-time RT-PCR cycle limit (CT), whereas five false positive test results were from samples from pre-operative patients.

 

 

Human Streptococcus Pneumoniae (SP) Antigen Rapid Test Kit

abx092096-20tests 20 tests
EUR 398

Avian Influenza Virus Antigen Rapid Test Kit (Colloidal gold)

abx092015-40tests 40 tests
EUR 432

Newcastle Disease Virus Antigen Rapid Test Kit (Colloidal gold)

abx092016-40tests 40 tests
EUR 432

Human Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal gold)

abx092049-20tests 20 tests
EUR 230

Rapid Leishmania Ab Test Kit

RB2104 1 box
EUR 127
Description: Please check the datasheet of Rapid Leishmania Ab Test Kit before using the test.

Rapid PED Ag Test Kit

RG14-01 1 box
EUR 159.9
Description: Please check the datasheet of Rapid PED Ag Test Kit before using the test.

Melamine (MEL) Rapid Test Kit

abx092057-50tests 50 tests
EUR 370

Clenbuterol (CLE) Rapid Test Kit

abx092058-50tests 50 tests
EUR 244

Ractopamine (RAC) Rapid Test Kit

abx092059-50tests 50 tests
EUR 244

Salbutamol (SAL) Rapid Test Kit

abx092060-50tests 50 tests
EUR 244

Tetracycline (TCs) Rapid Test Kit

abx092063-50tests 50 tests
EUR 398

Sulfonamides (Sas) Rapid Test Kit

abx092064-40tests 40 tests
EUR 398

Quinolones (QNs) Rapid Test Kit

abx092065-40tests 40 tests
EUR 398

Ciprofloxacin (CPFX) Rapid Test Kit

abx092066-50tests 50 tests
EUR 398

Quinolones (QNs) Rapid Test Kit

abx092067-40tests 40 tests
EUR 398

Brucella Antibody Rapid Test Kit

abx092069-40tests 40 tests
EUR 356

IBD rapid test strip

RG15-04 10 boxes
EUR 148
Description: Please check the datasheet of IBD rapid test strip before using the test.

Rabies rapid test strip

RG18-01 10 boxes
EUR 151.92
Description: Please check the datasheet of Rabies rapid test strip before using the test.

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

abx092014-40tests 40 tests
EUR 488

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

abx092017-40tests 40 tests
EUR 432

Accu-Tell COVID-19 IgG/IgM Rapid Test

GEN-B352-20tests 20 tests
EUR 236
Description: A rapid test for detection of antibodies (IgG and IgM) for 2019-nCoV, the novel Coronavirus from the Wuhan strain. The test is easy to perform, takes 10 minutes to provide reliable results and is higly specific to the 2019-nCoV Coronavirus.

Accu-Tell COVID-19 IgG/IgM Rapid Test

GEN-B352-40tests 40 tests
EUR 321
Description: A rapid test for detection of antibodies (IgG and IgM) for 2019-nCoV, the novel Coronavirus from the Wuhan strain. The test is easy to perform, takes 10 minutes to provide reliable results and is higly specific to the 2019-nCoV Coronavirus.

Anigen Rapid FIV Ab Test Kit

RB22-01-DD 10 tests/Kit
EUR 129.8
Description: Please check the datasheet of Anigen Rapid FIV Ab Test Kit before using the test.

Rapid Bovine Brucella Ab Test Kit

RB23-01-DD 1 kit/10 tests
EUR 151.79
Description: Please check the datasheet of Rapid Bovine Brucella Ab Test Kit before using the test.

Rapid Bovine TB Ab Test Kit

RB23-02-DD 1 box
EUR 128.4
Description: Please check the datasheet of Rapid Bovine TB Ab Test Kit before using the test.

Rapid FMD NSP Ab Test Kit

RB28-02-DD 1 box
EUR 135.4
Description: Please check the datasheet of Rapid FMD NSP Ab Test Kit before using the test.

Ag rapid CDV Ag Test Kit

RG11-03 1 box
EUR 138.2
Description: Please check the datasheet of Ag rapid CDV Ag Test Kit before using the test.

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