RCHM-02071 Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen
AntigenRapid Diagnostic Test for the Detection ofSARS-CoV-2 AntigenRCHM-02071For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use only For prescription use onlyPackage Insert(Instructions for Use)Intended UseThe CareStartTM COVID-19 Antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within first five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen is generally detectable in nasopharyngeal or anterior nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. 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. For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection. The CareStartTM COVID-19 Antigen is intended for use in point of care settings and operated by healthcare professionals or trained users specifically instructed in the use of the CareStartTM COVID-19 Antigen and proper infection control procedures. The CareStartTM COVID-19 Antigen is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Summary and Explanation of the TestSince the first outbreak reported in December 2019, SARS-CoV-2 has spread rapidly worldwide, and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). Due to its highly contagious nature and global health crises, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO). SARS-CoV-2 continues to have devastating impacts on healthcare systems and the world economy including the U.S. The CareStartTM COVID-19 Antigen is a rapid (approximately 10 minutes) chromatographic immunoassay for the direct detection of the presence or absence of SARS-CoV-2 antigens in the respiratory specimens taken from patients with signs and symptoms who are suspected of COVID-19, or taken from asymptomatic individuals being tested serially, as described in the authorized intended use. The test is intended to be interpreted visually in both laboratory and near patient testing environments without an instrument.
Principles of the TestThe CareStartTM COVID-19 Antigen test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset, or who are asymptomatic and undergoing serial testing, as described in the intended use. Nasopharyngeal and anterior nasal swabs require a sample preparation step in which the sample is eluted into the extraction buffer solution. Extracted swab sample is added to the sample well of the test device to initiate the test. When the swab sample migrates in the test strip, SARS-CoV-2 viral antigens bind to anti-SARS-CoV-2 nucleocapsid protein antibodies conjugated to indicator and capture particles in the test strip forming an immune complex. The immune complex is then captured by the test line on the nitrocellulose membrane as it migrates through the strip. Test results are interpreted at 10 minutes. The presence of two colored lines in the control line region “C” and test line region “T” indicates COVID-19 positive. The presence of one colored line in the control line region “C” indicates COVID-19 negative. No appearance of a colored line in the control region “C” indicates an invalid test
Reagents and Materials Provided
Contents Name
Quantity (in a kit)
Description
Test device
20 each
Foil pouched test device containing one test strip which is encased in plastic device cassette.
Extraction vial / cap
2an0dvicaalsps
The extraction vial contains extraction buffer solution.
N(oarsnaal sopharyngeal) 20 each swab Positive control swab 1 each
Swabs for specimen collection. Recombinant SARS-CoV-2 nucleocapsid protein antigen is dried on the foam-tipped head.
Negative control swab 1 each Blank swab
Package insert
1 each Instructions for use
QInusticrukcRtieofenrse(nQcReI)
1 each Quick reference instructions
The following materials are needed but not provided: Pair of gloves Timer Biohazard or sharps container Micropipette
Warnings and PrecautionsFor prescription and in vitro diagnostic use only. This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. Immediately use after opening the test device in the pouch. In order to obtain accurate results, the test must follow this package insert. Excess blood or mucus on the swab specimen may interfere with test performance and may yield a false-positive result. Avoid touching any bleeding areas of the nasopharynx when collecting specimens. Do not interpret the test result before 10 minutes and after 15 minutes starting the test. Inadequate or inappropriate sample collection, storage, and transport can result in incorrect results. If specimen storage is necessary, swabs can be placed into extraction buffer for up to four hours. Specimens should not be stored dry. Do not use if the test device package is damaged. Do not use the kit contents beyond the expiration date. Do not eat, drink, or smoke in the area where the specimens and kit contents are handled. Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used kit contents. Dispose of used contents as biohazardous wastes in accordance with federal, state, and local requirements. Nitrile or latex gloves should be worn when performing this test. If the extraction buffer contacts the skin or eye, flush with copious amounts of water. The SARS-CoV-2 positive control swabs have been prepared from recombinant viral proteins and do not contain infectious material. Handle all specimens as though they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Reagents contain sodium azide, which is harmful if inhaled, swallowed, or exposed to skin. Contact with acids produces a very toxic gas. If there is contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up. Do not interchange kit contents from different lots. Do not re-use any contents in the kit as they are single-use only. For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS) located at accessbio.net.
Storage and StabilityStore the test kit as packaged between 1 ~ 30°C. The reagents and materials in the CareStartTM COVID-19 Antigen are stable until the expiration date printed on the outer packaging. Do not use beyond the expiration date. The test device must remain in the sealed pouch until use. Do not freeze any contents of the kit.Quality ControlInternal Quality Control:The CareStartTM COVID-19 Antigen contains a built-in internal procedural control that is included in the test device. A red-colored line appearing in the control region “C” is designed as an internal procedural control. The appearance of the procedural control line indicates that sufficient flow has occurred, and the functional integrity of the test device has been maintained. If the procedural control line does not develop in 10 minutes, the test result is considered invalid and retesting with a new device is recommended. If the internal procedural control line is still absent in the retest, please contact the Technical Support at +1-888-898-1270 (Available Hours: Mon. to Fri.: 8 a.m. 5 p.m.) or (24/7 available).External Control:External control is used to demonstrate that the test device and test procedure perform properly. It is recommended that positive and negative external control swabs are run once with every new lot, shipment, and each new user. External positive and negative control swabs are provided in the kit. The external control should be tested using the swab test procedure provided in this package insert or the quick reference instruction card. If the external control results are invalid, please contact the Technical Support at +1-888-898-1270 (Available Hours: Mon. to Fri.: 8 a.m. 5 p.m.) or (24/7 available) before testing patient specimens.Specimen Collection and HandlingAcceptable specimen type for testing with the CareStartTM COVID-19 Antigen is a direct nasopharyngeal and anterior nasal swab specimen. It is essential that correct specimen collection and preparation methods be followed. Inadequate specimen collection, improper specimen handling and/or transport may yield false results; therefore, specimen collection requires specific training and guidance due to the importance of specimen quality to obtain accurate test results. Specimens are stable for 4 hours in extraction buffer. Refer to the CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-nCoV/lab/ guidelines-clinical-specimens.htmlSwab Sample Collection Procedure Nasopharyngeal Swab CollectionProcedural NotesProcess the test sample immediately after collection. Use only recommended nasopharyngeal swab for specimen collection. Collect the specimen wearing safety gloves to avoid contamination. Do not touch the tip (specimen collection area) of the swab. Collect samples as soon as possible within 5 days of symptom onset.
1Remove a nasopharyngeal swab from the pouch.2TGorittnhheinelsaeeteencerthdptlayoeiasrusfttatnaitoenhnttnihdteclhteer’pseseloiosnpssihwsoateteetslaiqyartenirduonicilinrtveo’snabsfeilaasetrshcntneokeotntpshpchtt7eooara0iturlisstyenwhnndtaeuxatet;.rbngetfkrdireielnoeeotmsioprt.3Slowly rotate 3-5 times the swab over the surface of the posterior nasopharynx.4Leave swab in place for several seconds to absorb secretions. Slowly remove the swab from the nostril while rotating it.Anterior Nasal Swab Collection Procedural NotesProcess the test sample immediately after collection. Use only provided or recommended anterior nasal swab for specimen collection. Collect the specimen wearing safety gloves to avoid contamination Do not touch the tip (specimen collection area) of the swab. Collect samples as soon as possible within 5 days of symptom onset.1Remove a nasal swab from the pouch.2Insert the swab into one of patient’s nostrils up to 1 inch from the edge of the nostril.
Description of Symbols
In vitro diagnostic medical device Indicates a medical device that is intended to be used as an in vitro diagnostic medical device. Consult instructions for use Indicates the need for the user to consult the instructions for use. Manufacturer Indicates the medical device manufacturer.
Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified. Do not re-use Indicates a medical device that is intended for one use, or uses on a single patient during a single procedure. Use by date Indicates the date after which the medical device is not to be used.
Positive control Indicates a control material that is intended to verify the results in the expected positive range. Negative control Indicates a control material that is intended to verify the results in the expected negative range. Catalog number Indicates the manufacturer’s catalog number so that the medical device can be identified.
Caution Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Date of manufacture Indicates the date when the medical device was manufactured.Temperature limit Indicates the temperature limits to which the medical device can be safely exposed.
Do not use if the package is damaged Indicates a medical device that should not be used if the package has been damaged or opened. Contains sufficient for <n> tests Indicates the total number of IVD tests that can be performed with the IVD. Prescription-only
Manufactured by: Access Bio, Inc. 65 Clyde Road, Suite A. Somerset, NJ 08873, USA Tel: 732-873-4040 Fax: 732-873-4043 Email: Website: www.accessbio.netTechnical Support in the U.S. Tel: +1-888-898-1270 (Toll Free) Email:
MIntarnivuofaDcitaugrneodsftoicrs:, Inc. 2021 Santa Monica Blvd, #11 Santa Monica, CA 90404, USA Tel: 888-965-0301 Fax: 888-965-0302 Email: Website: www.intrivo.com
Document number: IFU-RCHM71-E Revision number: E Effective date: Apr. 15, 2021
3Slowly roll the swab 5 times over the surface of the nostril. Using the same swab, repeat this collection process in the other nostril. Take approximately 15 seconds to collect the specimen.4Slowly remove the swab from the nostril while rotating it.Test Procedures Procedural NotesAllow test devices, reagents, specimens, and/or controls to equilibrate to room temperature (15~30°C) prior to testing. Remove the CareStartTM COVID-19 Antigen test device and extraction vial from its foil pouch immediately before testing. The CareStartTM COVID-19 Antigen kit IS INTENDED to be used only with a direct nasopharyngeal or anterior nasal swab specimen. The CareStartTM COVID-19 Antigen kit IS NOT INTENDED for testing other liquid samples such as nasal wash, aspirate samples or samples in viral transport media as results can be compromised by over dilution.Direct Swab Test Procedure
PEEL OFF
1 2 Peel off aluminum foil seal from the top of the extraction vial
Place the swab into the extraction vial. Rotate the swab vigorously
containing the extraction buffer
at least 5 times.
PUSH FIRMLY
CLICK
3 Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab.
4 Close the vial with the provided cap and push firmly onto the vial.
TAP90°
5 Mix thoroughly by flicking the bottom of the tube.
6 Itsgswrirocpnnheeaaaeofeivqsemmsntseluisulsta.epprsllisittytbratllase2.eeetltmmeehdwAd.tpetpwwhliLrollllooeeeelehmepxawbelflittksav.ennreialeasitlsom6gorShctftebqtirdiuniecartuotormtauaehdoeonfilnedpnletyv(ehzse3tivsaedhaed)oaaonlebrmsldidautfaomthnrpmsmov1oiedaloneepepmdrvhselarvtteaopohhlitrooillaiopddeeeesffl the sample are added.
Start the timer
7Read and interpret the test result at 10 minutes. The test result should not be read and interpreted after 15 minutes.
10 min
WarningThe false positive, false negative, or invalid results may occur if the test is interpreted outside of the interpretation window.
Interpretation of Results
NOTE: The test results should be read and interpreted at 10 minutes after the sample application and the reading and interpretation of the results should not exceed 15 minutes. The test results should not be interpreted using any instruments.Positive: two distinct colored lines appear.
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NOTE: The color intensity in the test region will vary depending on the amount of SARS-CoV-2 nucleocapsid protein antigen present in the sample. Any faint colored line(s) in the test region(s) should be considered as positive.Negative:Onengearteivde-croeslourlet.d line only next to “C” indicates aNOTE: Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed.Invalid:Ivuiffisstaihinnbegleirnt,ehvtdeah-lecrideormleroesrauseiulndtlitinlsinigsiensovpinbaeltticadhimi.enReeceodn-nrdiutnrunotrhltinhreegeegitxinoetinsrtati”acoCltnit”oeeinssttinvimnioagetl.Serial Testing Results ReportingFmlikooerlliehsceouroliaadrl ottefesCsttOifnoVgrIDnp-e1rgo9a,gtrsiauvmechsr,eassau,dlatdsnitmiionandyaivlbidecuoannlefiwcremitshsaataroyrc,yloifstteehsectoirnengtiascwatitwhhiigthha COVID-19 or with suspected exposure to COVID-19 or in communities wmltiokioetChllieOhhcVouigIolDahd-r1pot9refesoCvtrOafolrVeernIsDpicd-oe1isno9igtf,ivisinneufccerohecmstaiuosmltnisnu. mnAinidatdidyeiivsatiilwdosounitaahbllselcowonwneitficpherromseusvaatatrkloyen,rnyoifcwtetehnosetferineixngpifseowcasitutliohroewnas.Limitations1uotts2whb3a4p5ad6ehu.d…..ieseermhgsrNepTIedrpFFEhetofffohpaaneosixaoeisttln,liegotdrireheslrdroudateormcaepempastcntrauscieemeanlnavydaeulitearnrtedsenelsisoiiftnrffiaeogedocrcwtnatopeelaaenersssffsiefmsrtl,sstosttouiaepsrbthcsarivrslilnfaanterytleinowaoosaest,ndtrcgeer,tiitetwerciif/aumsimt,dreqloennnhhteissaiiutraietoenooaounho(olcinuin>sufrlnngtreetctlrec1setdtsvseheoohd20aissaasnsbimntfia4.mpsluismriesigrtssnepdlathoytgntuptargelayrorifussileyectopynsttwuocecaaataaredwfrtitcttihnbapfiritseliiicolhoooffaldlacdaudsebneustnneenraSaiseslesrnfytddsAynoiwnencof)mipweRor.nntiostinrgSttrpBmopehm4ydhatraistuveehotmiaeuophtciinstesnitrvsammloeeitoubesueantaunterestpgelsmettetetreelteee.sesstpoidsmathvsntvofhw.ietoyeaeenecpardrrnyalhanleesuniendondtlasstloxo,d4aupwivrsmtchcfet8lecirtatiraiaaor2coarsaclhlavscl.eny.unty5oeietpofinbrsiluvoorurry.sµieaemnyrvnbAgsilnpadesilia/diffbetnbricmstcnlaryeifeutaofteetuLhotcffwttenecwedtraeehdtdmowdkyiaetraoeeifleienvootottandsdhohnegrrrtt,,. ebpattiw1parwr7d8pS(c9uFl1he1m1a1o1p11neiaoheuaAnnc4.2vvai7..01356eerrpinmaahhcsnasooeetiaattl..t……RtrRoTtlgTltiduhiiettituwvfmetullovcTguTTeFPcSTninhheuuhToRteolnagrhdietaihthrishr-oehoreehtaairepiemgolspeyCuesonltniiiyeepmiesssettcsniaes,easnvrlosiifeaedinitrtehrnuiwnltoegonttpmnnioats)eadVe-reierceoaolpesdppngntrcventanvahns-eetst.dpfeenisrnesoeoeei2ehuSarnel,nctteetvd.tmesvoglrivgrberhecleecltoydinwtgfeveaaftrreFcwcmaiooxits.pretoscoseafeicmanlnhneaitcoheltrpneletooritylicrnnobhlppludcaglievmreumunesaecnliiatvnnecevseeoseaesmeehdnrccienriia.oecatrlmmelnsn-naineeiteapoiroriattmfrlesnTbtknia.eeidoioehsstgrpflgemtSeaqeogoeemmcrtrnuefliseirseteAirysaarhclumuSfegbnrcumpvtyloenigntbpattRottAlaea.iaealeeiidcpinsetetepvolSdedntovlclRotel2sce.teieiefd.eae-eeefsodidtuoegnivefSn0Cvmvarrnpsmnrluearrt-cat2oeytsoliptpfaiCcehethncptitteeointnea0Vnnhrieatrvectorecoeurnvoyregdededs-eageiiot2mVaftmosmatndisieiiscshstacatposonl-snteftmitilohupeha2enbbenweechichrtnbsndtnaoaeeenedctfrnesldohlaee,etosiiisinoetunustsclsuocvryuehlaeepclfietowusrhpedlaefanrtltmasaddeudDrSndwehcierloino.iffoondwnrefAtlvlcciseedeetrdefishnfbnmdeeagtaveosRotarcveohioeeisupachllnmdodeSsnariucadeacttanloseeor-omslslebseaaemciruaaCuatgfdnpbnneteenoepsohdtocynloa,bsoeedesailpsStotsrecifestyatteVcsschtdmbrAilinanteavnuadehrloeiri-toeyohomorcRlwacebov2soe.oelnvctretwaeinrnaSaltsetogiauiriie2.ashintdota-tisenaerthgplpvelhtCnn0Pi’tchmaSnhbasntghera.edrao2.dooieAbeteallhtogpFel,riheiscir0irVfskntdrlRinmtealavrierwfiauye.m-hateooteeSgilinbna2nhmnsdhlimitenb-ldrtydiadnteeaetovnCesemiihaciscaenrd-staoncfoospodtTpsieestnipuratperesunfhVoreftduhcicoicnencrehravnfttel-idewtruseisseelornohi2ceapncehteipoticplnvecrtoldneiateaeoubotevnioamealgsocclet-vrhpicdaallcfacnnlinvallstaeerbneaosaiilisettapitvditnnumtcaiinvtupcatnvivrtisivecttetiiieornbigitectiisccooehehraaicrauuntsaetnieglsaaaaienoddnnnneeeky.ssstttt.,,llll..
CONDITIONS of AUTHORIZATION for LABORATORYThe CareStartTM COVID-19 Antigen test Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDAwebsite: https://www.fda.gov/medical-devices/coronavirus-disease -2019-covid-19-emergency-use-authorizations-medical-devices/vitrodiagnostics-euas. However, to assist clinical laboratories using the CareStartTM COVID-19 Antigen test (“your product” in the conditions below), the relevant Conditions of Authorization are listed below: A. Authorized laboratories1 using your product must include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media. B. Authorized laboratories using your product must use your product as outlined in the authorized labeling. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted. C. Authorized laboratories that receive your product must notify the relevant public health authorities of their intent to run your product prior to initiating testing. D. Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate. E. Authorized laboratories must collect information on the performance of your product and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: ) and ACCESS BIO, INC. (Technical Support at +1-888-898-1270 or ) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of your product of which they become aware. F. All operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling. G. ACCESS BIO, INC., authorized distributors, and authorized laboratories using your product must ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.1 The letter of authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation” as “authorized laboratories.”Performance Characteristics Clinical Performance Nasopharyngeal SwabTAmhnuetlitgic-elsininteitceapsltropusesprinefogcrtmnivaeasnosctpeuhdacyrhyiannrgatechateel rsUiws.tSaic.bsbseoptfewcteihmeeneCnSaewrpeetSertemarebtvTMearluC2aO0t2eV0dIDai-nn1d9a November 2020 against an FDA Emergency Use Authorized RT-PCR molecular assay as a comparator method. A total of three (3) POC investigational sites throughout the U.S. participated in the study. To be enrolled in the study, patients had to be presenting at the participating scCwtrOuiittVdheyrIinDiac-fi.e1vnA9etlieln(rp5fse)awctditaieitoynhsntCs.oOTfphVsreyeIDmspe-ap1ntt9itoeelmindkteswospnyitrsmheestpfeeatnovttemtihnrsegoatsrnhtaudetdmCylOeesaVeisttIetDisnt-ww1cl9ouelrsieskioyeenmsn/ypermotxolclpelmutdoss.imoonsf Tfrhoemfiorsntecnoollestcrtiel fdronmaseoapchhasruynbgjeecatluosrinagnsttearniodranrdascaolllsewctaibonwmasetchoolledcstfeodr the comparator method. The second collected nasopharyngeal swab from the same nostril was tested directly on the CareStartTM COVID-19 Antigen test to demonstrate the agreement with the comparator method. Testing was performed by six (6) operators with no laboratory experience and who were representative of the intended users. Operators were only using the QRI for the test without any training provided. A total of 180 nasopharyngeal swab specimens collected from individual symptomatic patients (within 5 days of onset) were considered ceovamlupaabreled. tTohtehepecorfmorpmaarantcoer mofetthheodCiasrperSetsaertnTMtedCOinVtIhDe-1t9abAlenstibgeelnowte. st CwaitrheiSnta5rtdTMayCsOoVfIsDy-m19pAtonmtigoennsentaasogpahinasrtytnhgeecaolmclipnaicraaltpoer rmfoertmhoadnce
CareStartTM COVID-19 AntigenPositive NegativeTotal Positive Percent Agreement (PPA) Negative Percent Agreement (NPA)
Comparator
Positive
Negative
Total
30
1
31
2
147
149
32
148
180
93.75% (95% CI: 79.85% 98.27%)
99.32% (95% CI: 96.27% 99.88%)
Tpscharteeieepnnetirnsfogwramitphaponliucctaestoiiogfnnthss,iasantneddsstpyhemarsfpontroommtaysneoctfebremeesanpyicrdalintiffoicerayrlilinynfvtehacletidisoeantpeoodrpffouorlrautsiseoerniiansl.
Patient DemographicsAge Group5 Years of Age 6-21 Years of Age 22-59 Years of Age 60 Years of Age
CareStartTM COVID-19 Antigen
Total #
Positive
Prevalence
0
0
0.00%
22
3
13.64%
134
27
20.15%
24
2
8.33%
Positive results broken down by days since symptom onset:
Days Since Symptom Onset1 2 3 45
CumuPlaots(iv+ite)ivReT-PCR CuCmOuVlPaIDotis-v1iet9ivCAeanr(e+tiS)gteanrtTM
0
0
7
7
15
15
23
22
32
30
PPA100.00% 100.00% 95.65% 93.75%
95% Confidence interval
64.57% 79.62% 79.01% 79.85%
100.00% 100.00% 99.23% 98.27%
Clinical Performance Anterior Nasal SwabThe clinical performance characteristics of the CareStartTM COVID-19 Antigen test using anterior nasal swab specimen were evaluated in a multi-site prospective study in the U.S. between November 2020 and December 2020 against an FDA Emergency Use Authorized RT-PCR miesntnuvoredolesyltcleicugdelaantirnitoeantrshssaaewlysistiatthusesdCayOtc,hoVprmIoaDutp-ig1eah9rnaotltsiuoktehratmshdyeemttoUhpot.bSode.m.pApsartraeotnsitcedainplmotaiftneetgehdtraeiintnectt(hluh3es)eiPopsonatiur/ntedti-xcyoci.pflTu-aoCstaiiobnrneeg criteria. All patients presented with fever or at least two symptoms of COVID-19 infection. The patients presenting the COVID-19 like symptoms within five (5) days of symptom onset at the study sites were enrolled. Clinical studies in asymptomatic patients undergoing serial testing are ongoing to establish the clinical performance. Two (2) nasal swabs were collected using the provided swabs. One (1) swab was tested on the CareStartTM COVID-19 Antigen test and the second swab was processed in transport media for the comparator method. Collection order for the swab to be tested on the CareStartTM COVID-19 Antigen test and the swab for reference testing was randomized. Testing was performed by eight (8) operators with no laboratory experience and who were representative of the intended users. Operators were only using the QRI for the test without any training provided. Appaettroifetoanrlmtosfa9n(w2ceinthaoisfnatlhs5ewCadabarysespSetoacfrimtTMoennCssOectVo)IlDlew-c1et9eredAfncrtooigmnesniidnetderivestiddcuoeamvl sapyluamraepbdtleot.moTathhtieec comparator method is presented in the tables below.
CwaitrheiSnta5rtdTMayCsOoVfIsDy-m19ptAonmtigoennseatnatgeariionrstnathsealccolminipcaarlapteorrfomrmetahnocde
CareStartTM COVID-19 Antigen
Positive
Comparator Negative
Total
Positive
34
0
34
Negative
5b
53
58
Total
39
53
92
Positive Percent Agreement (PPA)
87.18% (34/39) (95% CI: 73.29%-94.40%)
Negative Percent Agreement (NPA)
100.00% (53/53) (95% CI: 93.24%-100.00%)
bCOVID-19 was not detected in 0/5 False Negative specimens using an alternative FDA-EUA molecular AssayTpscharteeieepnnetirnsfogwramitphaponliucctaestoiiogfnnthss,iasantneddsstpyhemarsfpontroommtaysneoctfebremeesanpyicrdalintiffoicerayrlilinynfvtehacletidisoeantpeoodrpffouorlrautsiseoerniiansl.
Patient Demographics
Age Group5 Years of Age 6-21 Years of Age 22-59 Years of Age 60 Years of Age
CareStartTM COVID-19 Antigen
Total #
Positive
Prevalence
1
1
100.00%
38
13
34.21%
47
20
42.55%
6
0
0%
Positive results broken down by days since symptom onset:
Days Since Symptom Onset01 2 3 45
CumuPlaots(iv+ite)ivReT-PCR CuCmOuVlPaIDotis-v1iet9ivCAeanr(e+tiS)gteanrtTM
3
3
11
10
24
21
33
29
37
32
39
34
PPA100% 90.91% 87.50% 87.88% 86.49% 87.18%
95% Confidence interval
43.85% 62.27% 69.00% 72.68% 72.02% 73.30%
100.01% 98.38% 95.66% 95.19% 94.09% 94.40%
Analytical Sensitivity: Limit of Detection (LoD)The LoD for direct swab was established using heat-inactivated SARS-CoV-2 isolate USA-WA1/2020 (NR-52286). The strain was spiked into the pooled human nasal swab matrix obtained from multiple healthy volunteers eluted in VTM and confirmed as SARS-CoV-2 negative by RT-PCR to prepare positive samples. The estimated LoD found from the initial two-fold serial dilution test was confirmed by testing 20 replicates. The confirmed LoD for direct swab was 8 x 102 TCID50/ml.AMnicarloytbiciaallISnpteercfiefirceitnyc:eCross Reactivity (Exclusivity) andThe potential cross-reactivity (exclusivity) of a panel of common organisms was evaluated with SARS-CoV-2 negative samples using the CareStartTM COVID-19 Antigen test. Potential microbial interference was evaluated with samples containing heat-inactivated SARS-CoV-2 isolate USA-WA1/2020 at approximately 3x LoD. A total of 8 bacteria were tested at a target concentration of acpfpnupe/urmomxl.iomTnhaiateee,1lyw8h1vi0icr7huscwefuass/wmteelsrtweedittehastttaehdfienaaetlxcccooennpccteieonnnttrraaottfiiooMnnsoycfbo1ep.t5lwaxsem1e0na3 105.2and 107.9 TCID50/ml. All negative samples gave negative results at the concentrations of the potentially cross-reactive common organisms tested showing no cross-reactivity with CareStartTM COVID-19 Antigen assay. All samples with SARS-CoV-2 strain tested positive showing no microbial interference at the concentrations of the potentially interfering common organisms tested.
Potential Cross-Reactant
Adenovirus 1
MERS-Coronavirus, Irradiated Lysate
Bodetella pertussis
Adenovirus 7
Parainfluenza virus type 1
Candida albicans
Enterovirus 71, Tainan/4643/1998
Parainfluenza virus type 2
Chlamydophila pneumoniae
Human coronavirus(OC43)
Parainfluenza virus type 3
Haemophilus influenzae
Human coronavirus(229E)
Parainfluenza virus type 4
Legionella pneumophila
Human coronavirus(NL63) Respiratory syncytial virus Type B Mycoplasma pneumoniae
Human metapneumovirus(hMPV)
Rhinovirus
Staphylococcus aureus
Influenza A/Michigan/45/2015
SARS-Coronavirus
Staphylococcus epidermidis
Influenza B/Wisconsin/01/2010 Pooled human nasal wash
Streptococcus pneumoniae
Streptococcus pyogenes, Group A
To estimate the likelihood of cross-reactivity with SARS-CoV-2 of organisms that were not available for wet testing, in silico analysis using the Basic Local Alignment Search Tool (BLAST) managed by the National Center for Biotechnology Information (NCBI) was used to assess the degree of protein sequence homology. https://blast.ncbi.nlm.nih.gov/Blast.cgi?PAGE=Proteins&PROGRAM=blastp &BLAST_PROGRAMS=blastp&PAGE_TYPE=BlastSearch&BLAST_SPEC=blast 2seq&DATABASE=n/a&QUERY=&SUBJECTS=
The homology between SARS-CoV-2 nucleocapsid protein and human coronavirus HKU1 nucleocapsid protein is relatively low, at 36.7% across 86.4% of sequences, but cross-reactivity cannot be ruled out. The homology between SARS-CoV-2 nucleocapsid protein and Mycobacterium tuberculosis total protein (3,991 proteins) is relatively low, homology-based cross-reactivity can be ruled out. The homology between SARS-CoV-2 nucleocapsid protein and Pneumocystis jirovecii total protein (3,745 proteins) is relatively low, homology-based cross-reactivity can be ruled out. The homology between SARS-CoV-2 nucleocapsid protein and human coronavirus 229E nucleocapsid protein is relatively low, at 28.8% across 72.1% of sequences, but cross-reactivity cannot be ruled out. However, a result of the cross-reactivity wet study showed that CareStartTM COVID-19 Antigen had no cross-reactivity against human coronavirus 229E. No homologous protein was detected as a result of in silico assay with all the proteins (686 proteins) of Mycoplasma pneumoniae and the nucleocapsid protein (NP) of SARS-CoV-2.Endogenous Interfering Substances EffectTo assess substances with the potential to interfere with the performance of the CareStartTM COVID-19 Antigen, positive and negative samples were tested with the addition of potentially interfering substances. The SARS-CoV-2 target concentration in the positive samples was approximately 2x LoD. All samples tested produced expected results, demonstrating that the CareStartTM COVID-19 Antigen test performance was not affected by any of the 30 potentially interfering substances listed in the table below at the concentrations tested.
Potential Interfering SubstancesAcetaminophen Acetyl salicylic acid BeclomethasoneBenzocaine Budesonide Chlorpheniramine maleate Dexamethasone Dextromethorphan HBr Diphenhydramine HCl Ephedrine HCl Flunisolide Fluticasone Guaiacol Glyceryl Ether Histamine DihydrochlorideMenthol
Concentration10 mg/ml 15 mg/ml 0.5 mg/ml 5 mg/ml 2 mg/ml 5 mg/ml 1 mg/ml 2 mg/ml 5 mg/ml 10 mg/ml 5 mg/ml 1 mg/ml 20 mg/ml 10 mg/ml 10 mg/ml
Potential Interfering SubstancesMometasone MucinMupirocin OTC Throat drop (Halls) OTC Throat drop (Ricola) OTC Nasal spray (Afrin) OTC Nasal spray (VicksSinex) OTC Nasal spray (Zicam)Oxymetazoline HCl Phenylephrine HCl PhenylpropanolamineTobramycin Triamcinolone Whole BloodZanamivir
Concentration1 mg/ml 2%1 mg/ml 15% 15% 15% 15% 15%10 mg/ml 5 mg/ml 5 mg/ml 1 mg/ml 1 mg/ml4% 1 mg/ml
The interfering effects of biotin concentrations ranging between 625 ng/mL and 10 µg/mL were tested in a separate study. Biotin concentrations up to 1.25 µg/ml did not lead to false results. Biotin concentrations 2.5 µg/ml can cause false-negative COVID-19 results with the CareStartTM COVID-19 Antigen.High-dose Hook EffectThe CareStartTM COVID-19 Antigen was tested up to 105 TCID50 /ml of heat-inactivated SARS-CoV-2 strain and no high-dose hook effect was observed.Point of Care UseThe CareStartTM COVID-19 Antigen was demonstrated at near patient or Point of Care (POC) testing that non-laboratory personnel can perform the test accurately in the intended use environment. In addition, the robust use of the CareStartTM COVID-19 Antigen for near patient or Point of Care (POC) testing was demonstrated by thirteen (13) Flex studies.Technical SupportFor questions, or to report a problem, please call Technical Support at +1-888-898-1270 (Available Hours: Mon. to Fri.: 8 a.m. 5 p.m.) or (24/7 available).Test system problems may also be reported to the FDA using the MedWatch reporting system (phone: 1-800 FDA-1088; fax: 1-800 FDA-1078: or http://www.fda.gov/medwatch).
QRI-RCHM-E / Rev. C / Apr. 15, 2021
References
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