Serology Diagnostic Products

Focus Diagnostics recognizes your testing needs becausewe identify and evaluate trends in diagnostic testing.The products listed in this brochure were built in responseto these trends, allowing us to provide your laboratorywith the same assays that we use.We are committed to providing our partners with flexiblesolutions, reliability, and quality you know and trust.That is Focus Diagnostics’ standard of excellence.

Serology Diagnostic ProductsHerpeSelect ® Test KitsCatalog No. Product Description Reactions/KitIB0900G CE HerpeSelect ® 1 and 2 Immunoblot IgG 24FDA For the qualitative detection and differentiation of type-specific IgG antibodies to HSV-1and HSV-2 in human serum.EL0910G CE HerpeSelect ® 1 ELISA IgGFDA Herpes Simplex Virus-1 (HSV-1) ELISA IgG 96The assay utilizes purified recombinant HSV-1 glycoprotein-G antigen (gG1) for thequalitative detection of type-specific IgG antibodies to HSV-1 in human serum.EL0920G CE HerpeSelect ® 2 ELISA IgGFDA Herpes Simplex Virus-2 (HSV-2) ELISA IgG 96The assay utilizes purified recombinant HSV-2 glycoprotein-G antigen (gG2) for thequalitative detection of type-specific IgG antibodies to HSV-2 in human serum.DxSelect ELISA Test KitsCatalog No. Product Description Reactions/KitEL1500G CE Dengue Virus IgG DxSelect 96For the qualitative detection of IgG antibodies to Dengue Virus in human serum.The assay utilizes inactivated antigen for Dengue Virus Types 1 – 4.EL1500M CE Dengue Virus IgM Capture DxSelect 96For the qualitative detection of IgM antibodies to Dengue Virus in human serum.The assay utilizes inactivated antigen for Dengue Virus Types 1 – 4.EL1510 CE Dengue NS1 Antigen DxSelect 96For the early detection of dengue virus NS1 antigen in human serum. This test mayaid in the early diagnosis of dengue virus in human serum prior to the presence ofIgM or IgG antibodies.EL1600G CE Hantavirus IgG DxSelect 96For the qualitative detection of IgG antibodies to Hantavirus in human serum.The assay utilizes a blend of recombinant Hantavirus antigens.EL1600M CE Hantavirus IgM DxSelect 96For the qualitative detection of IgM antibodies to Hantavirus in human serum.The assay utilizes a blend of recombinant Hantavirus antigens.EL1700 FDA Histoplasma DxSelect 96The assay utilizes inactivated purified histoplasma antigen for the qualitativedetection of antibodies (IgG, IgM, and IgA) to Histoplasma capsulatum var.capsulatum in human serum.EL0100G CE Parvovirus B19 IgG DxSelect 96For the qualitative detection of IgG antibodies to parvovirus B19 in human serum.EL0100M CE Parvovirus B19 IgM DxSelect 96For the qualitative detection of IgM antibodies to parvovirus B19 in human serum.EL0300G CE West Nile Virus IgG DxSelect 96FDA For the qualitative detection of IgG antibodies to West Nile virus in human serum.EL0300M CE West Nile Virus IgM Capture DxSelect 96FDA For the qualitative detection of IgM antibodies to West Nile virus in human serum.

DxSelect IFA and IHA Test KitsCatalog No. Product Description Reactions/KitIF1450G CE Anaplasma phagocytophilum IFA IgG 120For the detection and semi-quantitation of IgG antibodies to Anaplasmaphagocytophilum, the causative agent of Human Granulocytic Anaplasmosis (HGA)in human serum. The assay uses a human isolate of A. phagocytophilum cultivatedin HL60 cells as the substrate.IF1450M CE Anaplasma phagocytophilum IFA IgM 120For the detection and semi-quantitation of IgM antibodies to Anaplasmaphagocytophilum, the causative agent of Human Granulocytic Anaplasmosis (HGA)in human serum. The assay uses a human isolate of A. phagocytophilum cultivatedin HL60 cells as the substrate.IF0300G FDA Arbovirus IFA IgG 80For the detection and semi-quantitation of IgG antibodies to St. Louis encephalitis (SLE),western equine encephalitis (WEE), eastern equine encephalitis (EEE), and Californiaencephalitis / La Crosse (CE) group viruses in human serum. Slide wells have fixedindividual spots of SLE, WEE, EEE, and CE in each well.IF0300M FDA Arbovirus IFA IgM 80For the detection and semi-quantitation of IgM antibodies to St. Louis encephalitis (SLE),western equine encephalitis (WEE), eastern equine encephalitis (EEE), and Californiaencephalitis / La Crosse (CE) group viruses in human serum. Slide wells have fixedindividual spots of SLE, WEE, EEE, and CE in each well.IF1300G CE Bartonella IFA IgG 80For the detection and semi-quantitation of IgG antibodies to Bartonella henselae andBartonella quintana in human serum. Slide wells have fixed individual spots of B. henselaeand B. quintana infected Vero cells in each well.IF1300M CE Bartonella IFA IgM 80For the detection and semi-quantitation of IgM antibodies to Bartonella henselae andBartonella quintana in human serum. Slide wells have fixed individual spots of B. henselaeand B. quintana cell suspension in each well.IF1250A CE Chlamydia MIF IgA 1200344For the detection and semi-quantitation of IgA antibodies to three Chlamydia speciesinhuman serum. Slide wells have fixed individual spots of C. pneumoniae, C. trachomatis,C. psittaci and background control in each well.IF1250G CE Chlamydia MIF IgG 1200344For the detection and semi-quantitation of IgG antibodies to three Chlamydia speciesinhuman serum. Slide wells have fixed individual spots of C. pneumoniae, C. trachomatis,C. psittaci and background control in each well.IF1250M CE Chlamydia MIF IgM 1200344For the detection and semi-quantitation of IgM antibodies to three Chlamydia speciesinhuman serum. Slide wells have fixed individual spots of C. pneumoniae, C. trachomatis,C. psittaci and background control in each well.IF0500 CE Epstein-Barr Nuclear Antigen (EBNA)FDA ACIF (Anti-Complement Immunofluorescence) 120For the detection and semi quantitation of antibodies to Epstein-Barr virus nuclearantigen in human serum.IF0700 CE Epstein-Barr Virus Early Antigen IFA 120FDA For the detection and semi-quantitation of human IgG antibodies to Epstein-Barr virus earlyantigens, both restricted (R) and diffuse (D), in human serum.IF0600G CE Epstein-Barr Virus VCA IFA IgG 120FDA For the detection and semi-quantitation of IgG antibodies to Epstein-Barr viral capsidantigen (VCA) in human serum.

Serology Diagnostic ProductsDxSelect IFA and IHA Test Kits (continued)Catalog No. Product Description Reactions/KitRIF0600M CE Epstein-Barr Virus (EBV) VCA IgM 120FDARecombinant IFA (RIFA ® )For the detection and semi quantitation of IgM antibodies to Epstein-Barr viralcapsid antigen (VCA) in human serum.IF0950 CE Legionella IFA 120FDA For the detection and semi-quantitation of antibodies to Legionella pneumophila serogroup1 and serogroups 2, 3, 4, 5, 6, 8 in human serum. Slide wells have individual spots of L.pneumophila serogroup 1 and a pool of L. pneumophila serogroups 2, 3, 4, 5, 6, 8.IH0100 CE Leptospirosis IHA 120FDAFor the detection and semi-quantitation of IgG antibodies to the genusLeptospira in human serum.IF0200G CE Q Fever IFA IgG 80FDA For the detection and semi-quantitation of IgG antibodies to Coxiella burnetii,the etiologic agent of Q fever in human serum. Slide wells have individual spotsof C. burnetii phase I and C. burnetii phase II in each well.IF0200M CE Q Fever IFA IgM 80FDA For the detection and semi-quantitation of IgM antibodies to Coxiella burnetii,the etiologic agent of Q fever in human serum. Slide wells have individual spotsof C. burnetii phase I and C. burnetii phase II in each well.IF0100G CE Rickettsia IFA IgG 80FDA For the detection and semi-quantitation of IgG antibodies to R. rickettsii,the etiologic agent of Rocky Mountain spotted fever, and to R. typhi, theetiologic agent of murine typhus, in human serum. Slide wells have individualspots of R. typhi and R. rickettsii in each well.IF0100M CE Rickettsia IFA IgM 80FDAFor the detection and semi-quantitation of IgM antibodies to R. rickettsii,the etiologic agent of Rocky Mountain spotted fever, and to R. typhi, theetiologic agent of murine typhus, in human serum. Slide wells have individualspots of R. typhi and R. rickettsii in each well.ConjugatesCatalog No. Product Description VolumeIF0003 EBNA ACIF Conjugate 2.0 mLIF0001 FITC IgG Conjugate 2.5 mLIF0001-3 FITC IgG Conjugate 3.3 mLIF0002 FITC IgM Conjugate 2.5 mLIF0002-3 FITC IgM Conjugate 3.3 mLRIF0610 FITC IgM Conjugate (For use with RIF0602 RIFA slide) 2.5 mLIF0010 IFA Polyvalent Conjugate 3.5 mLIF0011* IgG Conjugate Dual-Species (Blend of anti-human IgG FITC and anti-mouse IgG FITC) 3.5 mLIF0012* IgM Conjugate Dual-Species (Blend of anti-human IgM FITC and anti-mouse IgG FITC) 3.5 mLIF1209* IgA Conjugate Dual-Species (Blend of anti-human IgA FITC and anti-mouse IgG FITC) 3.5 mL*For use with Arbovirus, Bartonella, and Chlamydia controls.

Substrate Slides *Catalog No. Product Description Reactions/SlideIF1403 CE Anaplasma phagocytophilum (HGA) IFA IgG Substrate Slide 12IF1404 CE Anaplasma phagocytophilum (HGA) IFA IgM Substrate Slide 12IF0301 Arbovirus IFA Substrate Slide 8IF0904 Babesia (B. microti) IFA Substrate Slide 10IF1301 CE Bartonella IFA (Vero Cell Co-Culture) Substrate Slide 8IF1302 CE Bartonella IFA (Blood Agar Preparation) Substrate Slide 8IF1201 CE Chlamydia MIF Substrate Slide 120344IF0501 CE EBNA ACIF Substrate Slide 12IF0751 CE EBV Early Antigen IFA Substrate Slide and Sample Diluent 12(Sample diluent bottle comes with each purchase of 10 slides.)IF0601 CE EBV VCA IFA IgG Substrate Slide 12RIF0602 CE EBV VCA IgM Recombinant IFA (RIFA ® ) Substrate Slide 12IF1003 Ehrlichia chaffeensis (HME) IFA IgG Substrate Slide 12IF1004 Ehrlichia chaffeensis (HME) IFA IgM Substrate Slide 12IF0951 CE Legionella (L. pneumophila serogroups 1 and 2, 3, 4, 5, 6, 8) IFA Substrate Slide 12IF0201 CE Q Fever (Phase 1 and 2) IFA Substrate Slide 8IF0101 CE Rickettsia (R. typhi and R. rickettsii ) IFA Substrate Slide 8IF0104 CE Rickettsia conorii Substrate Slide 8*Packaged in multiples of 10 slides (minimum purchase 1 package of 10).Sample DiluentsCatalog No. Product Description VolumeIF0006-5 3% Yolk Sac Diluent 5 mLIF1316 Bartonella IgG Sample Diluent (10X) 6 mLIF0750 EBV Early Antigen Sample Diluent 50 mLIF0208 IgG Sample Diluent (5X) (For use with the Q Fever IFA slides) 5 mLIF0209 IgM Pretreatment Diluent (For use with the Rickettsia and Q Fever IFA slides) 5 mLIF0609 IgM Pretreatment Diluent (For use with the A. phagocytophilum [HGA], Arborvirus, 12 mLBabesia, Bartonella, Chlamydia, and E. Chaffeensis [HME] IFA slides)

Serology Diagnostic ProductsOrdering InformationCustomer Service/Placing OrdersTo place an order, contactDiagnostics Customer Service at:Phone: +1.562.240.6500Fax: +1.562.240.6510E-mail: DxCS@focusdx.comMail Address:Focus Diagnostics, Inc.Customer Service11331 Valley View StreetCypress, California 90630 USATerms and ConditionsFinancial PoliciesBased on approved credit, payment in fullis due 30 days from shipping date in U.S.dollars. A service charge of 1.5% per month(18% per annum) from date of invoice willbe charged after 30 days.Credit limits and terms may be changed byFocus Diagnostics due to failure to makepayments in a timely manner. Changes mayinclude requiring payment in full prior tofuture shipments. In the event that FocusDiagnostics is required to take legal or othercollection action on a customer’s account,the customer will be required to assumeresponsibility for all expenses incurredin connection with the collection action,including attorney fees, court costs, andcollection service costs.ShipmentsShipments are made using best routing asdetermined by Focus Diagnostics unlessotherwise specified by Customer. Items areshipped Monday through Friday, unlessotherwise requested.When ordering, please specify:• Company Name• Your Focus Account Number• Purchase Order Number• Ship To and Bill To Address• Product Catalog Number and Description• Quantity and Price• Special Shipping Conditions, if anyPackaging and FreightInternational shipments originating in theU.S.A. are F.O.B. Cypress, California, USA.A minimum packing and handling charge willbe included in the invoice. Customs chargesare the responsibility of the Customer.Any Customs charges incurred by FocusDiagnostics will be billed to the Customer.Biological materials are packaged andshipped in accordance with United StatesFederal regulations.Returned GoodsProducts purchased directly from FocusDiagnostics which are defective and/or donot meet manufacturer’s specifications aresubject to replacement when notified bythe Customer within 30 days of shipment.Return of merchandise and productreplacement must be approved in advanceby Diagnostics Technical Services. Claimsfor merchandise damaged during shipmentshould be filed against the carrier by thecustomer within seven (7) days of receiptof goods.Technical Service/Product InformationFor technical questions and productinformation, please visit our website orcontact our Technical Service Department at:Phone: +1.562.240.6500Fax: +1.562.240.6510E-mail: DxTS@focusdx.comWarrantyProducts will have a minimum of 90 daysshelf life at time of shipment to domesticCustomers and a minimum of 180 daysshelf life to international distributorsunless Customer is notified in advance byCustomer Service and accepts productswith less dating than stated here.Products are warrantied for the shelf lifeof the product against original defects inmaterial and/or workmanship, provided,however, that the product has been usedstrictly in accordance with the productlabeling. Focus Diagnostics disclaims allother warranties, expressed or implied,including without limitation any warrantiesof merchantability, or fitness for a particularpurpose, and in no event shall FocusDiagnostics be liable for consequentialdamages. Replacement of the productor refund of the purchase price is the soleremedy for the purchaser.LITERATURE FOR DISTRIBUTION OUTSIDE THE USA ONLYCypress, California 90630 USAwww.focusdx.com© Focus Diagnostics, Inc., 2013. All rights reserved.Focus Diagnostics, DxSelect, HerpeSelect, RIFA and the associatedlogos are the registered trademarks of Quest Diagnostics.DXCATI1213