® HLA-B*81 101.553-06/06u 99X April 2015 Rev. No: 00 Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts Gel Documentation Form and Worksheet HLA-B*81 (101.553-06/06u) Lot: 99X Expiry Date: 2017-October-01 Name:__________________ Test Date: ____________ Review Date:_______________ Sample ID:______________ Tested By: ____________ Reviewed By:_______________ DNA Conc.(ng/ul):________ Interpretation:___________ Failed lanes: ____________ Comments:________________ Gel Picture PHOTO DOCUMENT 1 2 3 4 175 410 405 285 AmpS Well No. Specific Reaction 5 6 7 8 9 800 1070 1070 1070 1070 1070 1070 1070 1 2 3 4 105 80 165 105 5 6 165 140 NC Well No. ICB 7 8 9 ‘ICB’ Internal Control Band, ‘AmpS’ Amplicon size Notes: Product sizes are approximate. For detailed information, see the lot-specific Specificity Table and Interpretation Table. This table is intended as a guide. For interpretation always use the Interpretation Table and/or Specificity Table. HLA-specific PCR products shorter than 125 base pairs have a lower intensity and are less sharp than longer PCR products. Primer mixes 3 and 5 may have tendencies of unspecific amplification. Primer mix 9 contains a negative control, which will amplify more than 95% of HLA amplicons as well as the amplicons generated by the control primer pairs matching the human growth hormone gene. HLA-specific PCR product sizes range from 75 to 200 base pairs and the PCR product generated by the HGH positive control primer pair is 430 base pairs. Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden For In Vitro Diagnostic Use Page 1 of 3 ® HLA-B*81 101.553-06/06u 99X Worksheet Well No. HLA-B allele 1,2,3 *81:01 4 *81:02, 07:174, 07:202, 07:222 *81:03 *81:04N *81:05 *81:06 *81:07 *07:02:01-07:02:38, 07:02:40-07:02:45, 07:04-07:06, 07:09-07:11, 07:15, 07:17, 07:2007:26, 07:28-07:31, 07:34-07:36, 07:39, 07:41-07:46, 07:48-07:49N, 07:51-07:52, 07:5407:59, 07:61-07:64, 07:66-07:68:03, 07:70-07:76, 07:79-07:82, 07:86-07:99, 07:10107:109, 07:111N-07:121, 07:123-07:136:02, 07:138, 07:140-07:161N, 07:164, 07:16607:173, 07:175-07:179, 07:181N-07:192, 07:194-07:195, 07:199-07:201N, 07:203-07:206, 07:208-07:213, 07:215-07:218, 07:220-07:221, 07:223-07:224, 07:226, 07:229-07:231N, 07:233-07:234, 07:236-07:238, 07:240-07:241, 42:05:01-42:05:02 *07:02:39, 07:07, 07:12, 07:14, 07:18:01-07:19, 07:33:01-07:33:03, 07:40, 07:53, 07:60, 07:77-07:78, 07:84, 07:100, 07:122, 07:137, 07:139, 07:162-07:163, 07:165, 07:193, 07:196-07:198, 07:214, 07:225, 07:227, 07:235, 07:239, 08:123, 08:132, 14:21, 38:26, 42:01:01-42:02, 42:04, 42:06, 42:08-42:10, 42:12-42:20, 45:06, 67:01:01-67:01:03, 67:0367:04, 73:01-73:02 *07:03, 07:08, 07:16, 07:27, 07:32, 07:37-07:38, 07:47, 07:50, 07:69, 07:85, 07:180, 07:207, 07:219, 07:228, 07:232, 08:79, 37:07, 40:15-40:16, 40:32, 40:98, 48:05, 48:08, 48:10, 48:12, 48:14 *07:13, 07:110 *07:65 *07:83 *15:20, 15:228, 15:305, 35:01:01:01-35:01:27, 35:01:29-35:30, 35:32:01-35:34, 35:3635:42:02, 35:44-35:45, 35:47-35:56, 35:58-35:59, 35:61:01-35:65Q, 35:67-35:72, 35:7435:75, 35:77-35:78, 35:80-35:86, 35:88-35:184, 35:187-35:228, 35:230-35:278, 48:02:0148:02:03, 51:01:01:01-51:24:05, 51:26-51:41N, 51:43-51:46, 51:48-51:156, 51:158:0151:163, 51:165-51:185, 52:01:01:01-52:06:02, 52:08-52:44, 53:01:01-53:39, 58:01:0158:02, 58:04-58:10N, 58:12-58:19, 58:21-58:29, 58:31N-58:69, 78:01:01-78:08 *27:01-27:11, 27:13-27:15, 27:17, 27:19-27:21, 27:25-27:28, 27:30-27:38, 27:40-27:58, 27:60-27:76, 27:78-27:91, 27:93-27:118, 27:120-27:128, 27:130-27:135, 44:90, 44:97, 54:01:01-54:01:06, 54:03-54:29, 54:31-54:34, 55:01:01-55:05, 55:07-55:17, 55:19-55:70, 56:01:01:01-56:04, 56:06-56:16, 56:18-56:20:02, 56:22, 56:24-56:32, 56:34-56:35, 56:3756:41, 56:43, 56:45, 82:01-82:03 *27:24 *35:66 *35:76, 35:186, 35:229, 56:05:01-56:05:02, 56:21, 56:36 *37:52, 38:11, C*03:137, C*03:182, C*07:351, C*12:82 *40:31, 40:45, 40:80, 48:01:01-48:01:06, 48:06-48:07, 48:09, 48:11, 48:15-48:16, 48:1848:20, 48:22, 48:27-48:35 *48:04, 48:24 *48:36 *54:02 *67:02 *67:05 *83:01 C*07:102 Well No. Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts 1 2 1 1 1 1 1 1 1 2 ? ? ? ? ? 3 4 3 ? ? ? ? ? 4 4 4 4 4 4 4 3 4 5 6 7 8 9 5 5 6 6 7 8 3 4 3 2 3 4 4 4 Negative Control April 2015 Rev. No: 00 7 5 6 5 2 1 2 4 2 5 5 7 1 4 1 1 4 7 7 7 2 3 3 5 ? 2 1 2 3 4 5 6 w 7 8 9 1HLA-B*81 alleles in bold lettering are listed as confirmed alleles on the on the IMGT/HLA web page www.ebi.ac.uk/imgt/hla, release 3.19.0, January 2015. 2Alleles that have been deleted from or renamed in the official WHO HLA Nomenclature up to and including the last IMGT/HLA database release can be retrieved from web page http://hla.alleles.org/alleles/deleted.html. 3The B*81:02 and B*07:174, B*07:202 and B*07:2224 alleles will give rise to identical amplification patterns. These alleles can e.g. be distinguished by the HLA-B low resolution kit and/or HLA-B*07 high resolution kit. Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden For In Vitro Diagnostic Use Page 2 of 3 ® April 2015 Rev. No: 00 HLA-B*81 101.553-06/06u 99X Worksheet Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts 4Primer mix 5: Specific PCR fragment of 105 bp in the B*81:05 and the B*07:83 alleles. Specific PCR fragment of 165 bp in the B*81:03 and the B*15:20, 15:228, 15:305, 35:01:01:01-35:01:27, 35:01:29-35:30, 35:32:01-35:34, 35:3635:42:02, 35:44-35:45, 35:47-35:56, 35:58-35:59, 35:61:01-35:72, 35:74-35:78, 35:80-35:86, 35:88-35:184, 35:186-35:278, 48:02:01-48:02:03, 51:01:01:01-51:24:05, 51:26-51:41N, 51:43-51:46, 51:48-51:156, 51:158:0151:163, 51:165-51:185, 52:01:01:01-52:06:02, 52:08-52:44, 53:01:01-53:39, 56:05:01-56:05:02, 56:21, 56:36, 58:01:01-58:02, 58:04-58:10N, 58:12-58:19, 58:21-58:29, 58:31N-58:69, 67:05, 78:01:01-78:08 and 83:01? alleles. Primer mix 6: Specific PCR fragment of 80 bp in the B*81:04N allele. Specific PCR fragment of 105 bp in the B*81:05 and the B*07:83 alleles. ‘w’, may be weakly amplified. ‘?’, the nucleotide sequence of the primer matching region is not known. Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden For In Vitro Diagnostic Use Page 3 of 3