Summary

Effectivity Traits

JOYSBIO’s coronavirus Ag take a look at gear was independently evaluated at Centro Diagnostico Delta S.r.l. in Italy between October 2020 and January 2021. A whole of 107 constructive specimens had been examined with JOYSBIO’s COVID-19 Antigen Speedy Confirm Instruments. These specimens had been collected from victims who’re suspected of COVID-19 with nasal swabs. The coronavirus antigen take a look at gear’s sensitivity and specificity are in distinction within the course of a CE-IVD marked RT-PCR take a look at gear. This medical analysis is carried out beneath the idea SARS-CoV simply is not spreading domestically. 

Based totally on the medical evaluation 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%)
• Adversarial % 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 restrict of detection (LOD) of this product is 1.6 x 10² TCID₅₀/mL, calculated by means of a gradient dilution methodology.

Please Observe:

 Beneath listed kits are validated with the talked about batch quantity solely. Duty for batch to batch consistency wouldn’t lies with ICMR.
 Minimal acceptance necessities of sensitivity and specificity of Speedy Ag Confirm Kits:
 Validated as a Stage of Care Confirm (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 primarily based completely speedy assessments which could be US-FDA permitted will likely be utilized immediately after due selling and promoting approval from DCGI.

In June 2020, JOYSBIO Biotechnology proudly launched a mannequin new COVID-19 Antigen Speedy Confirm Instruments (Colloidal Gold). The mannequin new coronavirus antigen take a look at gear is a lateral switch immunoassay for the qualitative detection of SARS-COV-2 antigen (nucleocapsid protein) in bigger respiratory samples with nasal swabs or saliva within the midst of the acute a part of an an an infection. An uncut sheet format is available on the market.

Selections

• 15-minute speedy detection
• Easy-to-operate coronavirus antigen take a look at
• Lots less-invasive nasal (NS) swab pattern assortment
• CE-IVD marked
• Accessible in half/5/20 assessments/topic.

 

Strategies

The speedy SARS-CoV-2 antigen detection take a look at, Customary Q COVID-19 Ag gear (SD Biosensor®, Republic of Korea), was in distinction with the real-time RT-PCR take a look at, Allplex 2019-nCoV Assay (Seegene®, Korea) for detection of SARS-CoV-2 in respiratory specimens. 4 hundred fifty-four respiratory samples (primarily nasopharyngeal and throat swabs) had been obtained from COVID-19 suspected conditions and converse to of us, together with pre-operative victims at Siriraj Hospital, Bangkok, Thailand all by way of March–May 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 scale from onset to laboratory take a look at in COVID-19 suspected conditions and converse to of us ranged from Zero to 14 days with a median of three days. The speedy SARS-CoV-2 antigen detection take a look at’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 take a look at consequence was from a pattern with a excessive real-time RT-PCR cycle threshold (Ct), whereas 5 false constructive take a look at outcomes had been from specimens of pre-operative victims.

SARS-CoV-2 Antigen Rapid Test Kit
CoV2Ag-25	UnScience	25T/kit	EUR 42
Description: This product is used for in vitro qualitative detection of SARS-CoV-2 antigen in human oropharyngeal swabs, nasal swabs and nasopharyngeal swabs. It is helpful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of SARS-CoV-2 infection.

NOVATest Antigen Rapid Test Kit (For Single Use) (NOVA Test)
nCov-500-01	Atlas Link Technology	1T	EUR 162

Melamine Rapid Test Kit
abx092011-50tests	Abbexa	50 tests	EUR 444

NDV rapid test kit
RG15-03	Bionote	1 box	EUR 166.86
Description: Please check the datasheet of NDV rapid test kit before using the test.

Human Streptococcus Pneumoniae (SP) Antigen Rapid Test Kit
abx092096-20tests	Abbexa	20 tests	EUR 477.6

SARS-CoV-2 Rapid Antigen Test Nasal
9901-NCOV-03G	Roche Diagnostics	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

Avian Influenza Virus Antigen Rapid Test Kit (Colloidal gold)
abx092015-40tests	Abbexa	40 tests	EUR 518.4

Newcastle Disease Virus Antigen Rapid Test Kit (Colloidal gold)
abx092016-40tests	Abbexa	40 tests	EUR 518.4

Human Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal gold)
abx092049-20tests	Abbexa	20 tests	EUR 276

Melamine (MEL) Rapid Test Kit
abx092057-50tests	Abbexa	50 tests	EUR 444

Clenbuterol (CLE) Rapid Test Kit
abx092058-50tests	Abbexa	50 tests	EUR 292.8

Ractopamine (RAC) Rapid Test Kit
abx092059-50tests	Abbexa	50 tests	EUR 292.8

Salbutamol (SAL) Rapid Test Kit
abx092060-50tests	Abbexa	50 tests	EUR 292.8

Tetracycline (TCs) Rapid Test Kit
abx092063-50tests	Abbexa	50 tests	EUR 477.6

Sulfonamides (Sas) Rapid Test Kit
abx092064-40tests	Abbexa	40 tests	EUR 477.6

Quinolones (QNs) Rapid Test Kit
abx092065-40tests	Abbexa	40 tests	EUR 477.6

Ciprofloxacin (CPFX) Rapid Test Kit
abx092066-50tests	Abbexa	50 tests	EUR 477.6

Quinolones (QNs) Rapid Test Kit
abx092067-40tests	Abbexa	40 tests	EUR 477.6

Brucella Antibody Rapid Test Kit
abx092069-40tests	Abbexa	40 tests	EUR 427.2

Rapid Leishmania Ab Test Kit
RB2104	Bionote	1 box	EUR 152.4
Description: Please check the datasheet of Rapid Leishmania Ab Test Kit before using the test.

Rapid PED Ag Test Kit
RG14-01	Bionote	1 box	EUR 191.88
Description: Please check the datasheet of Rapid PED Ag Test Kit before using the test.

IBD rapid test strip
RG15-04	Bionote	10 boxes	EUR 177.6
Description: Please check the datasheet of IBD rapid test strip before using the test.

Rabies rapid test strip
RG18-01	Bionote	10 boxes	EUR 182.3
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	Abbexa	40 tests	EUR 585.6

Avian Influenza H7 Virus Antigen Rapid Test Kit (Colloidal gold)
abx092017-40tests	Abbexa	40 tests	EUR 518.4

Accu-Tell COVID-19 IgG/IgM Rapid Test
GEN-B352-20tests	Accu test	20 tests	EUR 283.2
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	Accu test	40 tests	EUR 385.2
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.

Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva)
IOV87952	INVBIO	20T/kit	EUR 46.8
Description: Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in human saliva, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronvirus antigen. It will provide information for clinical doctors to prescribe correct medications.

Clenbuterol Rapid Test Kit (Colloidal gold)
abx092040-50tests	Abbexa	50 tests	EUR 326.4

×