Please Observe:
 Beneath listed kits are validated with the talked about batch quantity solely. Duty for batch to batch consistency doesn’t lies with ICMR.
 Minimal acceptance standards of sensitivity and specificity of Speedy Ag Take a look at Kits:
 Validated as a Level of Care Take a look at (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 mostly speedy exams that are US-FDA permitted can be utilized immediately after due advertising and marketing approval from DCGI.

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 take a look at package is a lateral move 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 section of an infection. An uncut sheet format is offered.

Options

• 15-minute speedy detection
• Simple-to-operate coronavirus antigen take a look at
• Much less-invasive nasal (NS) swab pattern assortment
• CE-IVD marked
• Out there in half/5/20 exams/field.

Efficiency Traits

JOYSBIO’s coronavirus Ag take a look at package was independently evaluated at Centro Diagnostico Delta S.r.l. in Italy between October 2020 and January 2021. A complete of 107 constructive specimens had been examined with JOYSBIO’s COVID-19 Antigen Speedy Take a look at Package. These specimens had been collected from sufferers who’re suspected of COVID-19 with nasal swabs. The coronavirus antigen take a look at package’s sensitivity and specificity are in contrast towards a CE-IVD marked RT-PCR take a look at package. This scientific analysis is performed below the idea that SARS-CoV is not spreading in the neighborhood. 

In line with the scientific evaluation of 492 samples, the detection sensitivity is 98.13%, and the specificity is 99.22%.

• Optimistic P.c Settlement (PPA) = 105/107 (98.13%) (95%CI: 93.4%~99.8%)
• Detrimental P.c 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.

COVID-19 Antigen Take a look at Process

1. Twist off the cap of the buffer bottle, rigorously dispense all buffer into the extraction tube。 
2. 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 towards the underside of the tube, rotate three turns. DO NOT splash liquid out of the tube. 
3. Take away the swab whereas squeezing the edges of the tube to extract the liquid from the swab. 
4. Press the nozzle cap firmly onto the extraction tube. Combine completely by swirling or flicking the underside of the tube. 
5. Gently squeeze the tube’s inflexible physique, dispense two (2) drops of the buffer-specimen combination into the pattern effectively on the coronavirus antigen take a look at cassette.
6. Learn the take a look at outcomes between 15 and 20 minutes. Don’t learn the outcomes after 20 minutes.

Key Factors

• This interim steerage is meant for healthcare suppliers who order antigen exams, obtain antigen take a look at outcomes, or carry out point-of-care testing, in addition to for laboratory professionals who carry out antigen testing in a laboratory setting or on the level of care and report these outcomes.
• The aim of this interim technical steerage is to help efficient scientific and public well being use of antigen exams for various testing conditions.
• This steerage applies to all scientific and shopper makes use of of antigen exams and isn’t particular to any explicit age group.

Summary

Background

The Coronavirus illness 2019 (COVID-19) pandemic continues to unfold internationally. Therefore, there’s an pressing want for speedy, easy, and correct exams to diagnose extreme acute respiratory syndrome coronavirus 2 (SARS-CoV-2) an infection. Efficiency traits of the speedy SARS-CoV-2 antigen detection take a look at must be evaluated and in contrast with the gold customary real-time reverse transcription-polymerase chain response (RT-PCR) take a look at for prognosis of COVID-19 circumstances.

Strategies

The speedy SARS-CoV-2 antigen detection take a look at, Customary™ Q COVID-19 Ag package (SD Biosensor®, Republic of Korea), was in contrast 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 circumstances and make contact with people, together with pre-operative sufferers at Siriraj Hospital, Bangkok, Thailand throughout March–Might 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 length from onset to laboratory take a look at in COVID-19 suspected circumstances and make contact with people 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 end result 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 sufferers.

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