»~D Bioline . Diagnostics Salmonella typhi (IgG/IgM) Test For rapid qualitative detection of both Salmonella typhi antibodies, 1g ‘and IgM in human serum and plasma, ‘Only for in Vitro diagnostic use. CLINICAL SIGNIFICANCE “Typhoid fever and paralyphi fever are bacterial infections caused by ‘Saimonelia Typhi and paratyohoid A, B, C respectively, which Is transmitted tough the ingestion of tainted food and water. Worldwde an estimated 17 rillon cases end 600,000 associated deaths occur annually. Patients who are Infected with HIV are at signfeanily increased rsk of clinical infection. 1-5% of patients become chronie carers harboring S. typhi in the galladder The nical diagnosis of infections depends on isolation of S. typhi and parayoh {tom blood, bone marrow or a specie anatomic lesien. In facies that can not {atfid fo perform this complicated and time-consuming procedure, Fibs testis used to faciitate clagnosis. However. mary limitations led to difculties inthe interpretation of the Wieal test n contrast, Typhow IgGligh Rapid Tests ‘2 simple fast laberoory test fet simultaneously detects and olerertiates 1g ‘and IgM anibodies to S. typhi and paratyohi antigen thus aiding in the {termination of curent or previous exposure to S. typhi and paralyphi. IgM sitive or IgM gG both postive suggest current infection, whit IgG postve ‘suggests late stage of infection, or previous infection or latent infection, PRINCIPLE “Typhoid IgG/igl Rapid Testis lateral tow ehrematographie mmunoassay. “The test cassette consists of. 1) « burgundy colored conjugate pad containing recombinant Hariigen and © antigen conjugated with colloid gold (HO conjugates) and rabotlgG-gold conjugates, 2) 2 nitocelulose membrane sip Centaring no lest bands (G and M bands) and a control band (C band), The Mand is pre-coated with monoclonal antinuman IgM fr the detection ofl ant-S. typi and patalph, G bands. pre-coaled with reagents for the {tection of IgG ant-S typi and paralyphi and the C band fs pre-coated with ‘goo ant rab 9G. see et [When an adequate volume ol fest specimen & dspeneed ho the sample well fof the cassette, the tet specimen migrates by capilary action across the test ‘casseto. IgM antibodies If presert in te patient specimen wil bind tothe HO ‘conjugates. The immunocomplex is then captured on the membrane by the pie-coated antihuman IgM anibody, forming @ burgundy colored M band, Indicating aS. typhi or parayph Ight positve test result IgG antibodies 11 pesent In the patient specimen Wil bind to the HO conjugates. The Immunocomplax ‘is then captured “by the pre-coated reagents on. the ‘membrane, forming 2 burgundy colored G band, indicating a S. typhi oF [paratyph IgG. postive test result. Absence of any test bands (Mt and G) Suggests a negative rest. The tat containe an infernal cant! (c bane) which ‘sholld exhbita Burgundy colored band ef te immunocompex gost ant rabbr IgGirabbitlgG-gold conjugate regards of the color development on any of the test bands Otferse, the fst result i Invallé and the specimen must be ‘eles wath aromner sevice KIT COMPONENTS Test Device, Assay Butler, Sample Dropper and product insert PRECAUTIONS For in Vitro Diagnostic Use 1. This package insert must be read completly before pertering the test, Failure to follow the inert gee inaccurate test result. Do nol open the sesled pou, unless ready to conduct the assay, (Do not use expired devices. Bing all reagents to room temperature (15°C-20°C) before use Do not use the components in any othe ype of est Kt asa substitute for the components inthis ke ‘Wear protective clothing and disposable gloves whle handling the kt reagents and cinical specimens. Wash hands thorcughly afer performing the tet, 7. Users of hs test should follow the US CDC Universal Precautions for prevertion of ranamission cf HV. HEV and alherbiood-nome pathogens 8. Donot smoke, dink, or eat in areas where specimens or kit reagents are being handles 9. Dispose of al specimens and materials used to perform the test as Diohazardous vaste, 10. Handle the Negative and Postive Contin the same manner as patent specimens. 11, ‘The taeting result shouldbe read within 15 minutes after @epacimen te applied to the eample wel or sample pad ofthe device, Reading the test ‘after 15 minutes may give erroneous results. STORAGE & STABILITY ‘Store 2 packaged in the sealed pouch at 2-30 “C. The test device is stable through the expration date printed on the sealed pouch, The fest cevice must remain in the sealed pouch uni use, Do not feeze. ‘SPECIMEN COLLECTION & PRESERVATION Consider any materials of human origin as infectious and handle them using standard biosafety procecutes. Plasma 4. Collect blood epecimen ino a lavender. blue or green top collection tube (containing EDTA, ciate or heparin, respectively in Vacutainer®) by Yeinpuncture, 2. Separate the plasma by centrifugation. 3. Carefuly witheraw the plasma into a new prelabeled tube, ‘serum 1. Collect blood specimen into a red top collection tube (containing no “articoagutanten Vaculainer®) by velnpuncture ‘Allow the blood to clot Separate the serum by centiftugaton, Carey witha th serum into a new prelabeled tube Test specimens as soon as possible after collecting. Store specimens at 2°C-8°C if nol tested mmediaely. Store specimens at 2°C-8°C for up to 5 ‘ays. The specimens should be azen at-20°C for longer storage [Avold multiple feeze-thaw cycles. Prlor ta testing, ong frozen specimens to oom temperature siowy and mix gently. Specimens containing vsile Particulate mater should be clarified by ceniifugation before testing. Do not {ise samples demonetating gross lipemia, gross hemolysis or turbidity In order to avoid inerterence on result interpretation Directions for Use 1. Bring the specimen and test components to room temperature i refrigerated o frozen. Mit the specimen wel pir to assay once thawed 2. When ready to tes, open the pouch at tne notch and remove device, Place the test device na clean, fat surface. 3. Be sure fo label the device with specimer's IO number 44. Filthe pete dropper withthe specimen. Holcing the dropper vertically, dspense 2 drop of specimen into the sample well making sue that there are no ai bubbles Then add drop of bufer immediately. e —— Resuit 5. Setuptin 5. Results can be readin 15:20 minutes, Don't read result after 20 minutes. To avoid contusion, discard the test device ater interpreting the result. INTERPRETATION OF RESULTS NEGATIVE OR NON-REACTIVE RESULT. Ifonly the C band is present, the Absence of any burgundy cele inthe Bol test ands (M and G)ineates that1 ants. yh or paretypy antibody Is detected in the specimen, The results negative or nonreactive. POSITIVE OR REACTIVE RESULT. 1, In adion to the presence of C banc, if only M band js developed, the test Indicate for the presence of ant S. bhi or partyphi Ight the specimen. The result ie Igh postive or reactive Zin aaliton to he presence of Cand, only G band is devetoped, the test Indicates for the presence of anl-S. hh or paratyi IgG in the specimen. The results IgG posi or reactive, Tw adalion 10 Ue presence Of C band boi Mand G bards ave developed, the test indicates forthe presence of ant-S. ph or partyah IgG and igM in the specimen. The resus both IgG and Igh postive of reactive ‘Samples with postive or reactive results should be confimed with atematve {esting metnea(s) and clinical fraings bofore a postive dotarmation i made. INVALID: Ino C band is developed, the assay is inva regardless of any ‘burgundy color inthe test bands as indicated below. Repeat the assay wih 2 new device PERFORMANCE CHARACTERISTICS 4. Clinical Performance for IgM Test A total of 334 samples from susceplble subjects were tested by Typhoid IgGiigh Rapid Test arc by a cemmercial 8. yphi IgM EIA, Comparison for al sbjects is shown n the folowing table Typhoid igGigh Rapid Test IgM ETA Posiive Negative Toial Positive 31 3 Es Nogative 2 25 30 “Total 35 302 336 Falatve Sensiiy. 91%, Relive Spectily. 8.3%, Overal Agieamert 98.5% 2. Clinical Performance For IgG Test A total of 914 samples from susceptible subjects were tested by Typhoid IgGiigh Rapid Test and by @ commercial S. typ IgG EIA kit Comparson for a eubjec le chown Inthe folowing table “Typhoid IgGiiga Rapid Test 1gG EA Positive Negative Toial Positive 43 i 14 Nogative 2 208 300 “Total is 29 ae Relative Sensitivity: 92.0%, Relative Specify: 99.9%, Ove 930% 3. Performance comparison with blood culture Nine (8) 5. paratypni and eleven (1) S:typhi specimens confimed wih the blood culture were tested with Typhoid IgGilgM Rapid Test Typhod IgGioM Repid Test correctly indented 9 S. peralyhi A and 10 S. typhi specimens. ‘The agreement was 95%. LIMITATIONS: 1. The Assay Procedure andthe Test Resul Interpretation must be folowed closely when testing the presence of antibodies fo S. typhi or paratyph in fetum or plasma from Individual subjects. Failure to folow the procedure may give inaccurat resus 2. Typhoid IgGiight Rapid Testis limited to the qualitative detection of arliboties to S. (yphi or paratyphi in human serum of plasma. The intensiy’ of the test band dose not have linear correlation wit the antibody tern the specmen 3. Anegatve resul for an individual subject inccates absence of delectable ‘antiS. toh or paratyh antibadies. However. 2 negative test resut does nel preclude the posstaly of exposure to S. typhi or paralyph 4. negative resut can occur fhe quantiy of ani-S. typhi or parlyehi ‘ntibodies present in the specimen is below the detection limit of the ‘nesey,orthe antibodies that are detected are not present ding the fogs ‘of aiscase in which @ sample scolected, 5. tthe symptom pefsists, while the feu rom Typhold IgGght Rapid Test 's negative or non-reactive result, it is recommended to re-sample the Petlert few days late of test with an altematve test method, such as bacteria cutture method, 8. Some specimens containing unusualy high iter of heteropile antibodies ‘or rhoumatoi factor may aflect expected resis. 7. The results obtained with this test should only be interpreted in cenjunction wih other diagnostic procedures and enical ings BIBLIOGRAPHY 1. Ivanoff BN, Levine MM, Lambert PH. Vaccination agalnst typhoid fever: present status. Buletin ofthe World Health Orgarization 1904; 72: 957- 71, 2 Goluzz0 F, Frisancho ©, Sanchez J, Liendo 6, Carilo C, Black RE, Mortis JG, Association beiween the eoquied immunodetciency syndrome ‘and infection with Salmonela typhi or Salmonella parstyoh in an endemic ‘typhoid area, Arches of Internal Medicine 1991; 151, S81-2 ul Bioline Diagnostics LLP #41478 USDC Nalanda re, ah 120040 (NOK) E sini nregyit