Osom Trich 181 Pi

7/29/2019 Osom Trich 181 Pi

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FOR LABORATORY AND PROFESSIONAL USE ONLY

INTENDED USEThe OSOM Tric ho m on a s Ra p id Test is intend ed for the q ua lita tive de tec tion of Tricho mo na s va g inalis( Tricho mo na s ) antig en s from vag inal swa b s or from the sa line solution p rep a red wh en m a king w etm ou nts from va g ina l swa b s. This test is intend ed for use in p a tient s w ith sym pto m s of va g inosis/ va g initis

or susp ec ted expo sure to the Tricho mo na s p a tho g en.

SUMMARY AND EXPLANATION OF TESTTric ho mo na s infec tion is resp on sible fo r the m ost c om m on, no n-vira l sexua lly tra nsm itted d isea se(vag initis or trichomo nia sis) wo rld w ide . Tric ho mo nia sis is a sign ific a nt c a use o f mo rb idity a m ong a llinfected pa tients.(1,2) Effec tive d iag no sis a nd trea tme nt of Tricho mo na s infec tions ha ve b ee n show nto e limina te symp tom s.(2) Co nventiona l ide ntific a tion proc ed ures for Tricho mo na s from vag inal swa b sor va g inal wa shes involve the isola tion and sub seq uent ide ntific a tion of via b le pa tho g en s by wetmo unt microsc op y or by c ulture, (3) a p roc ess tha t c a n ta ke 24 120 ho urs. Wet m ount m icrosc opyha s a rep o rted sensitivity of 58% versus c ultu re. (4) The OSOM Tricho m ona s Ra p id Test is a nimm unoc hrom a tog ra p hic a ssa y that d etec ts p a thog en a ntige ns d irec t ly from vag ina l swa b s.Results a re rap id, oc c urring w ithin ap p roxima tely 10 minutes.

PRINCIPLE OF TESTThe OSOM Tricho mo na s Ra p id Test u ses c olor immu noc hrom a tog ra p hic, c a p illary flow, d ipsticktec hno log y. The te st p roc ed ure req uires the solub iliza tion o f Tric ho m on a s p rote ins from a va g ina l swa bby mixing the swa b in Sa m p le Buf fe r. The O SOM Tric ho mona s Ra p id Test Stic k is the n p lac ed in thesa mp le mixture a nd the mixture m igra tes a long the me mb ra ne surfa c e. If Tric hom ona s is p resent inthe sa m p le, it will form a c om p lex with the p rima ry a nti-Tricho mo na s a ntibo d y co njuga ted to c oloredp a rt ic les (blue). The c om p lex will then b e b ound by a sec ond a nti-Tric hom ona s a ntibo d y co a ted on thenitroc ellulose m em b ra ne. The a p p ea ra nc e o f a visible b lue test line a long w ith the red c ontrol l ine w illind ica te a p ositive result.

REAGENTS AND MATERIALS PROVIDED

25 Test St ic ks25 Ste rile Swa b s25 Test Tub es1 Sa m p le Buf fer via l, 25 m l (sa line b uffe r w ith 0.01% sod ium a zide)1 Sa mp le Buffer drop p er top1 Positive c ontrol swa b (c onta ins sod ium a zid e a nd a d esicc a nt tab let)1 Worksta tion1 Direc tiona l InsertNote: Extra c om p one nts (swa b s, tub es) have b ee n provid ed for your c onve nienc eWa rning: Co nta ins Sod ium Az ide

MATERIAL REQUIRED BUT NOT PROVIDED

A t imer or watc h

WARNING AND PRECAUTIONS For in vitrod iag no stic u se o nly. Follow your c linica l a nd / or la b orato ry sa fety g uide lines in the c ollec ting, ha nd ling, storing, a nd

d isp osing of p a tient sp ec ime ns, a nd a ll item s exposed to p a tient sp ec ime ns. Swa b s, test tub es,a nd Test Stic ks a re fo r sing le use o nly.

The Sa mp le Buffer co ntains sa line solution with a p reservat ive (sod ium a zide) a nd a d eterge nt a t lowc on c en tra tions. If so lution c ome s in co nta c t w ith the skin or eyes, flush w ith lot s of w a te r.

Solutions tha t co nta in sod ium azid e m a y rea c t explosively with lea d o r c op p er plumb ing. Use largeq ua ntities of wa ter to flush d isc a rd ed so lutions d ow n a sink.

Do not u se o r mix c om p on ents from d ifferent kit lots.

STORAGE CONDITIONS Sto re Test Stic ks a nd rea g en ts tigh tly c a p p ed a t room tem p era ture (15 30 C). Do not free ze. Do no t use Test Stic ks a nd rea g en ts a fte r exp ira tion d a te. Disc a rd un used Test Stic ks tha t have b ee n rem ove d from the c a nister afte r 1 ho ur.

SPECIM EN COLLECTION AND PREPARATION Co llec t sp ec imens from the va g inal ca vity with a sterile ra yon swa b from the kit. Use o f the swa b s sup p lied in the kit or BD BBL Cultu reSwa b (ste rile o r w ith Liquid Stua rts Me d ia)

is rec om me nd ed . Swa b s from othe r sup p liers ha ve not b ee n valid a ted . Swa b s with co tto n tip sor woo d en shaft s a re not rec om me nd ed .

C LIA Com plex ity: Wa ivedTrichomonas Rapid Test


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Proc ess the swa b a s soo n as p ossible af ter c ollec ting the sp ec imen. Sp ec imens ma y be he ld a t roo mtem p era ture for no lo ng er tha n 24 ho urs. Swa b s ma y a lso b e stored a t 4 C o r -20 C fo r up to 36 hou rs.

To tra nsp ort pa tient sa mp les p lac e swa b in a c lea n, d ry c onta iner suc h a s a p lastic or glass tub e. The solution rem a ining in the te st tub e used for the w et m ount m a y also b e used a s the sa mp le for

the OSOM test. To use this sa m p le typ e , so a k a ne w k it swa b in this so lut io n. Using this swa b , pe rfo rmth e c o m p l e t e te s t p r o c e d u r e d e ta ile d b e lo w . The re m ust b e e nou g h solution left af ter the wet m ou ntto soa k the ne w swa b c om p letely. These sa line sp ec imen s ma y be h eld a t roo m tem p erature for nolong er tha n 24 ho urs. The se sp ec ime ns ma y a lso b e sto red a t 4 C o r -20 C fo r up to 36 hours.

To run a c ulture a s we ll a s the OSOM Test, sep a ra te swa b s mu st b e c ollec ted b ec a use the Sa mp leBuffe r will kill Tric ho mona s o rg a nism s.

QUALITY CONTROL ( QC)The OSOM Tric ho mo na s Ra p id Test p rovid es tw o m ethod s of c ontrol fo r the a ssa y: interna l co ntrols toa id in dete rmining te st validity, and external co ntrols to d em on stra te p rop er test func tion.

I n te rna l Proc e d ura l C ont ro l s Seve ra l c on tro ls a re inc o rpo ra ted into ea c h Test Stic k for rou tine q ua lity c he c ks.

1. The a p p ea ra nc e o f the c ontrol line in the results wind ow is a n interna l po sitive p roc ed ura l co ntrol.

Te st Syste m : The a p p ea ra nc e of the c ontrol l ine a ssures tha t ad eq ua te sa mp le volume w a s p resent.It also a ssures tha t ad eq ua te c a p illary m ig ra tion of the sa mp le ha s oc c urred a nd ve rifies p rop era ssem b ly of the Test Stic k.

O p e r a t o r : The a p p ea ra nc e o f the c ontrol line indica tes that e noug h sa mp le volume w a s p resentfor c a p illary flow to o c c ur. If the c ontrol line d oe s not a p p ea r a t the rea d time, the test is invalid.

2. The c lea ring of the b a c kg rou nd in the results a rea ma y be d oc um ente d a s a n internal neg a tivep roc ed ura l c ontrol. It a lso serves a s a n a d d ition a l c a p illa ry flow c ontrol. At the rea d time, theb a c kg rou nd shou ld a p p ea r wh ite to lig ht grey a nd no t interfere w ith the read ing of the test. Thetest is invalid if the b a c kg rou nd fails to c lea r a nd hide s the a p p ea ra nc e of a d istinct c ontrol l ine.If the b a c kg roun d c olor do es not c lea r a nd interferes with the test result, the test ma y be inva lid .Ca ll Sekisui Dia g no stic s Tec hnic a l Assista nc e a t (800) 332-1042 if you expe rienc e a p rob lem .

Exte rna l Q ua l ity C o ntro l Te sting

OSOM

Test kits inc lude a Positive C ontrol Swa b for externa l qua lity c ontrol testing . Kit swa b s m a yb e used a s neg a tive c ontrols. Add itiona l Positive Co ntrol Swa b s ma y be p urc ha sed sep a ra tely.The Tric ho m ona s Positive Co ntrol Kit is c a ta log num b er 182. Use t he Co ntrols to e nsure tha t the TestSticks a re func tioning p rop erly. Also, the Co ntrols ma y be used to d em on stra te p rop er pe rforma nc eby the te st op erato r. Qu a lity Co ntrol req uirem ents shou ld be esta b lished in a c c orda nc e w ith loc a l,sta te a nd fe d era l reg ula tions o r a c c red itation req uirem ent s. Minima lly, Sekisui Diag no stic srec om me nd s tha t po sit ive a nd neg a tive externa l c ontrols be run with ea c h new lot, a nd w ithea c h new untra ined o p era tor.

Q C Te st ing Proc e d ure s The Positive Co ntrol Swa b is imp reg na ted w ith suffic ient Tric ho mo na s a ntige n to p rod uc e a v isiblep ositive te st result. To p erfo rm a p ositive o r neg a tive c ontrol test, c om p lete t he step s in the Test

Proc ed ure sec tion trea ting the c ontrol swa b in the sa me m a nne r a s a sp ec imen swa b.

EXPECTED RESULTSStud ies ha ve show n tha t the inc ide nc e o f Tricho mo na s infec tions by c ulture in wo me n p resenting toSTD c linic s is b etween 8 37%.(1,2) In a c linic a l tria l involving the OSOM Tric ho mona s Ra p id Test a t seve nsites, inc luding STD c linics, hosp ita l eme rg enc y d ep a rtme nts, and p ub lic hea lth c linics, the p reva lenc eof Tric ho mo na s Infec tions d ete c ted by cu lture o r we t mo unt ra ng ed from 13% to 29%. Up to 50% ofwo me n infec ted w ith Tricho mo na s ma y not be a wa re of symp tom olog y. The highe st inc id enc e of thisd isea se is found in wo m en w ith at-risk fac tors tha t p red isp ose the m to a c q uiring sexua lly tra nsm ittedd isea ses. Tric ho mo nia sis a lso h a s a high likeliho od of c o -infec tion w ith oth er STDs, inc lud ing t ho se t ha ta lso result in sym pto m s of va g initis.

LIM ITATIONS OF THE PROCEDURE The OSOM Tric ho m ona s Ra p id Test is only for the q ua lita tive d ete c tion o f T. vag ina lisa ntige n from

vag inal swa b s a nd th e sa line solution rem a ining from a w et mo unt of a va g inal swa b. The p erforma nc e of the OSOM Tric ho mo na s Ra p id Test with sp ec ime ns oth er tha n vag ina l fluid o r

the sa line solution rem a ining from a w et mo unt of a va g inal swa b ha s not b ee n esta b lished . The results ob ta ined w ith this kit yield d a ta tha t must b e used on ly as a n ad junct to o the r informa tion

a vaila b le to the p hysic ia n. This test do es not d ifferentiate b etw ee n via b le and non -via b le org a nisms. This test d oe s not d ifferentiate b etw ee n ind ividua ls tha t a re c a rriers a nd individ ua ls tha t ha ve a n

a c ute infect ion. Pa tient s w ith va g initis/ va g inosis sym pto m s ma y ha ve mixed infec tions. The refo re a test ind ica ting the

p resenc e of T. vag ina lisd oe s not rule ou t the p resenc e of Ca nd ida vulvovag initis o r Ba c teria l vag inosis.

A neg a tive result ma y be o bta ined if the spe c ime n co llec t ion is inad eq uate o r if ant ige n co nce ntra t ionis b e low t he sen sitivity of the te st. A ne g a tive OSOM Tric ho m ona s Ra p id Test result ma y wa rra nta d d it iona l pa t ient fol low up.

Wom en w ith vag ina l d isc ha rg e should b e eva lua ted for risk fa c tors of c ervic it is a nd p elvic infla mm a toryd isea se a nd for other orga nisms includ ing Neisseria gonorroeaea nd Chlam ydia trac homa tis.

Sa mp les c onta minated with prep a ra t ions c onta ining iod ine or by the imm ed ia te prior use of vag ina llub ric a nts a re not rec om me nd ed .

Sta p hyloc oc c us a ureusin sp ec imens a t c onc entrations highe r than 1x108 orga nism s p e r mL m a yinterfere with t he test results in neg a tive sa m p les. The se c onc ent ra tions of S. a ureusa re higher thanwo uld b e expe c ted to be p resent in norma l pa t ient sa mp les.(5)


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PERFORMANCE CHARACTERISTIC SVag inal sa mp les we re c ollec ted from a tota l of 449 c on senting a d ult p a tients p resenting to o ne o f sevena d ult hea lth c ente rs. The sp ec imen s we re te sted for Tric hom ona s by w et m ount mic rosc op y, culture(InPouc h TV BioM ed Diag no stic s, Inc ., Sa n Jose, CA) a nd the O SOM Tricho mona s Ra p id Test.

Diag no stic Sen sitivity a nd Sp ec ific ity Versus Wet M ou nt M ic rosc op y Sta nd a rd Ana lysisThe p erforma nc e o f the OSOM Tricho mo na s Ra p id Test wa s d ete rmined using the a c c ep tedc a lc ulations for co mp a ra tive sen sitivity and sp ec ific ity ag a inst the results from wet mo unt m ic rosc op y.(6)The results from th is a na lysis (w ith 95% c onfid enc e inte rva ls in pa renthesis) a re sum ma rized in Ta b le 1.

Ta b le 1COMPARISON OF OSOM TRICHOMONA S RAPID TEST TO WET MOUNT MICROSCOPY

*Of the 20 sa mp les neg a tive b y wet m ou nt 16 were po sitive b y cu lture - 4 we re ne g a tive.

Diag no stic Sen sitivity and Sp ec ific ity Co mp osite Refe ren c e Sta nd a rd Ana lysisThe rela tive insen sitivity of we t mo unt m icrosc op y versus c ulture ha s b ee n rep o rted in the litera ture.(4)Therefore, the p erforma nc e o f the O SOM Trichom on a s Ra p id Test wa s a na lyzed using a c om p ositerefe renc e sta nd a rd (C RS) (7) c a lculat ion, wh ich includ es the results from we t mo unt mic rosc op y andc ultu re ( InPouc h TV, BioM ed Diag no stic s, Inc ., Sa n Jose, CA) . In th is a na lysis, any sa m p le w ith ap ositive result from eithe r we t mo unt o r c ulture wa s d efine d a s p ositive. Acc ord ingly, sa m p les tha t we reneg a tive in bo th wet m ou nt a nd c ulture te sts we re d efined a s neg a tive. The results of the c om p a risonof the OSOM Trich om on a s Ra p id Test using a sta nd a rd va g ina l swa b sa m p le to t he CRS a re show n in

Ta b le 2; 95% c on fide nc e interva ls in p a ren the sis.

The results of t he c om p a rison o f the OSOM Tric ho mona s Ra p id Test using th e sa line rem a ining froma wet mo unt sa mp le a re show n in Ta b le 3. The c om p a ra tive sen sitivity of e a c h m etho d to the CRS isshow n in Ta b le 4.

Ta b le 2COMPARISON OF OSOM TRICHOMONA S RAPID TEST TO COMPOSITE REFERENCE STANDARD

*Of the 20 sa mp les neg a tive b y wet m ou nt 16 were po sitive b y cu lture - 4 we re ne g a tive.

Ta b le 3COMPARISON OF OSOM TRICHOMONA S RAPID TEST SALINE FROM WET MOUNT SAMPLE

TO COMPOSITE REFERENCE STANDARD

M e thod Se nsi tiv i ty

OSOMTric hom ona s Ra p id Test (va g ina l swa b ) 83%

OSOMTric hom ona s Ra p id Test (sa line from wet mount) 75%

Wet Mount Mic rosc opy 71%

Culture (InPouc h TV) 99%

Ta b le 4SENSITIVITY OF EAC H METHO D VERSUS COMPOSITE REFERENCE STANDARD

Sensitiv ity: 79/105 = 75% (95% CI, 67 84%)Sp ec ific ity : 337/ 342 = 99% (95% CI, 97 100%)Ag ree m ent : 416/ 447 = 93% (95% CI, 91 95%)

+ - Tota l

+ 79 5 84

- 26 337 363

Tota l 105 342 447

CompositeReference

Sta nd a rd

O S O M

Tric h o m o n a s

Ra p id Te st(sa line fromwet mount)

Sensitiv ity: 85/ 102 = 83% (95% CI, 76 91%)

Sp ec ific ity : 331/ 335 = 99% (95% CI, 98 100%)Ag ree m ent : 416/437 = 95% (95% CI, 93 97%)

+ - Tota l

+ 85 4* 89

- 17 331 348

Tota l 102 335 437

Composite

ReferenceSta nd a rd

O S O M

Tric h o m o n a s

Ra p id Te st(va gina l swa b)

Sensitiv ity: 69/ 72 = 96% (95% CI, 91 100%)Sp ec ific ity : 345/ 365 = 95% (95% CI, 92 97%)Ag ree m ent : 414/437 = 95% (95% CI, 93 97%)

+ - Tota l

+ 69 20* 89

- 3 345 348

Tota l 72 365 437

Wet MountMicroscopy

O S O M

Tric h o m o n a s

Ra p id Te st(va gina l swa b)


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PO L Stud iesAn eva luation of the O SOM Tric ho m on a s Ra p id Test wa s c on d uc ted a t four physicia n offic es. Ea c h sitetested a ra nd om ly c od ed p a nel of neg a tive (6), low p ositive (3), and high p ositive sa mp les (3). Threeop erato rs a t ea c h site ran a ll 12 sa mp les, which p rod uc ed the follow ing results:

Sa mp le Agreem entNeg a tive 100% (95% CI, 95 100%)Low 97% (95% CI, 85 100%)High 100% (95% CI, 90 100%)

Assa y Re p rod uc ib il ity Intra-a ssa y a nd inte r-a ssa y rep rod uc ibility stud ies d em onstrate d 100% a g ree m ent w ith expec ted results.Testing w a s p erfo rmed by two op e ra to rs, on t hree lots of OSOM Tricho m ona s Ra p id Test kits, usinglab orato ry p rep a ra tions of high p ositive, low p ositive a nd ne g a tive T. vag ina lissa m p les. Fo r intra -a ssa yrep rod uc ibility e a c h sa mp le wa s tested tw ent y times within one run. For inter-a ssa y rep rod uc ibilitysa mp les we re te sted in dup lic a te, tw o runs p er da y, over five c on sec utive da ys.

A na lytica l Se nsit ivi tyThe OSOMTric ho mo na s Ra p id Test d ete c ted a ntigen d erived from a s few a s 2500 o rg a nism s p er mL,a c onc entra t ion lower than tha t expec ted in the vag ina l d isc ha rge of mo st p osit ive p a tients.(8) For thesestud ies the a na lytica l sen sitivity of th ree rep resenta tive lots of th e O SOM Tric ho mona s Ra p id Test wa sd etermined using a ntige n p rep a red from c ultured T. vag ina lisorganisms.

TEST PROCEDURE

Ab so rb en t End

Test Line

Result Wind ow

Co ntrol Line

Ha nd le End

When o p en ing kit for the first t ime, unsc rew the c a p fromthe Sa mp le Buffer bo tt le and rep la c e it with the d rop p er topinclud ed in the kit. Disc a rd the o riginal Sa mp le Buffer ca p.

STEP 1: ADD SAMPLE BUFFERUsing the sup p lied d rop p er top, ad d 0.5 mL of Sa m p le Buffe r toea c h test tub e. Fill the d rop p er to the line indic a ted on the b a rrelof the d rop p er top a nd e xpe l ent ire c ontents into tube. N o t e : A d dSa m p le Buf fe r to t he t ube be fore p ut ting in the sp e c im e n swa b t op reve nt c ont a m ina t ing t he Sa m p le Buffe r v ia l.

STEP 2: MIX SWAB IN BUFFERPut the sp ec imen swa b into the tub e.

Vigo rou sly m ix the so lution by rota ting the swa b fo rc efu llya g a inst the side o f the tub e a t lea st ten times (while sub me rg ed ).Best results a re o b ta ined w he n the sp ec ime n is vigo rou sly m ixedin the so lution.

Allow the swa b to soa k in the Sa mp le Buffer for one minutep rio r to Step 3.

STEP 3: SQUEEZE LIQUID FROM SWAB

Sq uee ze o ut a s mu c h liq uid a s p ossible from the swa b byp inching the sid e o f the flexib le test tub e a s the swa b isrem oved . At lea st of Sa m p le Buffe r solution mu st rem a inin the tube for a d eq uate c a p illa ry mig ra t ion to oc c ur.

Disc a rd the swa b in a suita b le b ioha za rd ou s wa ste c onta iner.

STEP 4: ADD TEST STICK AND INCUBATERem ove th e OSOM Test Stic k from the c a nister pa c kag e.Rec a p the c a nister imme d iately.

Plac e the a b sorbe nt end (ind ica ted with arrow s, see p icture)

o f the Test Stic k into the Sa m p le Buffe r so lution in the t ub e. Unusedsticks rem oved from the c a nister shou ld b e d isc a rd ed a fter 1 hour.

STEP 5: READ RESULTSRea d results a t 10 m inute s (some p ositive results m a y be seenea rlier). See inte rpreta tion o f results sec tion. Test is inva lid b eyo ndthe stated rea d t ime.

N o te : To se e the Re sult Wind ow c lea rly, re m ove the Te st St ic k fro mthe te st tub e wh ile rea d ing resul ts.

Disc a rd used test tub e s a nd Te st St ic ks in suita b leb i o h a z a rd o u s w a ste c o n ta in e r.

A l low tosoa k for

1 m in

Fill Line

10x

I n c u b a t efo r 10 m in


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INTERPRETATION O F TEST RESULTSThe a p p ea ra nc e o f a red C on tro l Line, w ith or w ithou t a b lue Test Line, ind ica tes a va lid result. A b lueor red line t ha t a p p ea rs uneve n in co lor sha d ing is still co nside red a valid line. In c a ses of m od erate orhigh p ositive sp ec ime ns, some c o lor b eh ind t he Test Line m a y be see n. As long a s the Test Line a nd theCo ntrol Line a re visib le, the results a re va lid .

Positive

A b lue Test Line a nd a red Co ntrol Line is a p ositive result for the d ete c tion o f Tric ho mo na s a ntige n.N o te th a t th e r e d a n d b lu e l in e s c a n b e a n y sh a d e o f th a t c o lo r a n d c a n b e lig h t e r o r d a rk e r th a n th el ine in the p ic ture .

N e g a t i v e

A red C ontrol Line b ut no b lue Test Line is a p resum p tive neg a tive result. A ne g a tive result me a ns tha tno Tricho mo na s a ntigen w a s d etec ted , or tha t the level of the a ntige n in the sa mp le wa s b elow thed etec tion limit of the a ssa y.

Inva lid

If no red Co ntrol Line a p p ea rs or ba c kg roun d c olor ma kes rea d ing the red Co ntrol Line imp ossible,the result is inva lid . If this oc c urs, rep ea t the test on a new Test Stic k or c onta c t Sekisui Dia g no stic sTec hn ica l Assista nc e.

Ana ly t ic a l Spe c ific ity The OSOM Tricho mo na s Ra p id Test ha s b ee n show n to b e no n-rea c tive w ith norma l vag inal flora a ndinfec tious a g ents (inc luding Ga rd nerella vag inalisa nd Ca ndida spe c ies).

Positive a nd neg a tive c ontrol sa mp les we re te sted a g a inst the follow ing p ote ntial interferents with noa ffect on the p erforma nc e of the OSOM Tric ho mo na s Ra p id te st:

O r g a n i s m sBa c teriod es me rd a e Ga rd nerella va g inalis Mo b ulunc us c urtsii Shige lla flexneriCa nd ida a lbic a ns Tritricho mo na s foetu s Mo nella c holerae suis Sta p hyloc oc c us a ureu sChlam ydia tra c hom atis Neisseria go norrhoea e Sa lmone lla typhimurium Strep toc oc c us a ga lac tia e

Esc heric hia c oli

T. foetus, C. tra c ho ma tis, a nd C. albica nssa m p les tested a t a p p roxima te ly 0.5 x 105. All oth er sa m p lestested a t ap p roxima tely 1x108 o rg a nism s/ m L. Sta p hyloc oc c us a ureusin spe c ime ns a t c onc entra t ionshig he r tha n 1x108 o rg a nism s p er m L ma y inte rfere w ith the te st results in neg a tive sa m p les. The sec onc entra tions of S. Aureusa re highe r tha n would b e expe c ted to be p resent in norma l p a tient sa mp les.(5)

O the r Sub sta nc e sCo nd om s, with sp ermic ide HeLa c ells Hum a n b lood Vag inal yea st trea tm entDouc he (vineg a r) HVEC c ells TYM Cu lture Me d ium (Mo nista t brand)

Sa mp les c onta minated with prep a ra t ions c onta ining do uc he me d ic ate d w ith iod ine ma y interferew ith ne g a tive sa m p les (p lea se refe r to Limitat ions sec tion).


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REFERENCES1. Ca tes, W., Estima tes of the inc ide nc e a nd p reva lenc e o f sexua lly tra nsm itted d isea ses in the

United Sta te s, Sex Tra nsm Dis 26: S2 S7, 1999.2. World Hea lth Orga niza tion, An o verview of se lec ted c urab le sexua lly transm itted d isea ses, pp . 2 27,

in Glob a l Prog ra m o n AIDS, Ge neva , Sw itze rlan d, World Hea lth Orga niza tion, 1995.3. Ohlem eye r, C., Hom b erg er, L., Lync h, D. a nd Sw ierkosz, E., Diag no sis of Tric ho m ona s va g ina lis in

a d ole sc en t fem a les: InPou c h TV cu lture versus we t-mo unt m icrosc opy, J Ad olesc Hea lth,22:205 208, 1998.

4. Wiese, W., Pa te l, S.R., Pa te l, S.C., Ohl, C., and Estrad a , C., A m eta -a na lysis o f the Pa p a nic o laou smea ra nd wet m ount fo r the d iag no sis of vag inal tric hom on iasis, Am J Med,108:301 8, 2000.

5. Hoc hwa lt, A., Berg , R., Meye r, S., a nd Euseb io, R. Site -sp ec ific p reva lenc e a nd c e ll d ensities o f se lec tedmic rob es in the lowe r rep rod uc tive trac t of me nstruating ta mp on users, Infec t Dis Ob stet Gyne c ol,10:141 151, 2002.

6. Ga len, R. an d Ga m b ino, S., Beyond Norma lity: The Pred ictive Va lue a nd Effic ienc y of Me d ica lDiagnoses, New York, John Wiley & Sons, 1975.

7. Alo nzo, T. & Pep e M ., Using a Co m b ina tion of Refe renc e Tests to A ssess the Ac c urac y of a NewDia g no stic Test, Sta tistic s in Me d ic ine, 18: 2987 3003, 1999.

8. Philip, A., Ca rter-Sc ot t, P., a nd Rog ers, C., An Ag a r Cu lture Tec hn ique to Q ua ntita te Tricho mo na svaginalisf rom Wom en, J Infec t Dis155:304, 1987.

ASSISTANCEFor tec hn ica l assista nc e, ca ll Sekisui Diag no stic s Tec hn ica l Assista nc e a t (800) 332-1042.

RE-ORDERNo. 181 OSOM Tricho m ona s Ra p id Test (25 te sts)No. 182 OSOM Tric ho m ona s Positive Co ntrol

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7/8

KEY TO COMPONENT LABELING

Use by YYYY-MM

Ba tc h cod e

Ca ta log numb er

Contents suffic ient for tests

In vitrod ia g nostic med ic a l d evic e

Temp era ture lim ita tion

Ma nufa c turer/ Ma nufa c tured by

Consult instruc tions for use

Autho rized rep resenta tivein the Europea n Community

Ca ution, c onsult ac c om pa nyingdocuments.


8/8

POSITIVE

NEGATIVE

INVALID

QUALITY

CONTROL(QC

)

InternalProceduralCon

trols

1.

Theappearanceofth

econtrollineintheresults

windowi

saninternal

positiveproceduralcontrol.

2.

Theclearingoftheba

ckgroundintheresultsarea

m

aybedocum

ented

asaninternalnegative

proceduralcontrol.

ExternalControls

SekisuiDiagno

sticsrecom

m

endsthatpositiveand

negativeexternalcontrolsberunwitheac

hnewl

otand

witheachnew

untrainedoperator.Onepositivecontrol

swab(pinksha

ft)isincludedwitheachkit.

Foranegative

control,runon

eofthesterileswabssuppliedwiththekit.

Runcontrolsin

thesam

emanneraspatientswabs.

Add

Sam

ple

Buffer

Fillthedroppertothe

lineindicatedonthe

barrelandexpelentire

contentsintotube.

M

ixSwab

in

Buffer

Addswabtotubea

nd

mixvigorously(app

rox.

10times).

Squeeze

Liquid

from

Swab

Squeezesideo

ftubeto

expressasmuc

hliquidfrom

swabaspossib

le.

Add

TestSt

ickand

Incubate

Placeabso

rbentendoftest

stickintoth

esolution.

Trichomon

asRapid

Test

Rev.

3084-0,

06/11

Allowt

o

soakfor

1m

in

4

5

3

2

1

FillLine

10x

Incubate

for10m

in

Posit

ive:A

blueTestLineandare

dControlLine.

Negative:A

redControlLinebut

noblueTestLine.

Invalid:IfnoredControlLineappearsorbackground

colo

rmakesreadingtheredControlLineim

possible.

Documents

Osom Trich 181 Pi